Archives
September 15, 2011
Congressman Ron Paul Introduces Bill to Protect Consumer Testimonials. HR 2908 the Testimonial Free Speech Act.
To protect the First Amendment rights of individuals to share their experiences and perceptions of the effects of foods and dietary supplements. In introducing this Bill, Congressman Paul stated, "...restricting communication of individuals' accounts of their experiences with foods and dietary supplements is a blatant violation of the First Amendment. The necessity for this bill shows how little respect the federal bureaucracy has for the Bill of Rights and the principles of a free society. I therefore urge my colleagues to join me in taking a small step toward restoring free speech by cosponsoring the Testimonial Free Speech Act."
Please sign and fax this letter to urge your Representative to co-sponsor HR 2908.
Stopping S. 1310: Lots of letters have gone to Capitol Hill urging Senators to block S. 1310; however, the battle is not won yet. Our immediate concern is getting through the next few weeks when omnibus appropriations bills go through to keep the government running. We are working hard to make sure Senator Durbin does not sneak all or part of this Bill onto one of these "must pass" bills.
FDA: 17 years after the passage of DSHEA, the FDA, when forced by a legislative deadline issued a Draft Guidance Document on New Dietary Ingredients (NDI) [Docket No. FDA–2011–D–0376]. The document is couched as a ‘non-binding’ guidance document which represents the agencies current thinking on new dietary ingredients. It is an 86 page document with 58 attachments. If finalized in its current form, it likely would curtail innovation, and potentially cause many products that were introduced after 1994 to come off the market until or unless they went through the NDI process. It could force many companies to fight the FDA in court to keep products in the marketplace. The 86 page document is highly technical and with many nuances. We as a community have succeeded in getting the FDA to extend the comment period to December 2. There is a move within the community to have the entire Guidance Document withdrawn. To support that position, please sign and fax in this letter.
A full analysis of the NDI will be posted on CodexFund.com shortly. Please come back to the site to learn how you can use the analysis to submit comments as well.
July 7, 2011
ALERT! Senator Dick Durbin's Latest Attack on Dietary Supplements - S. 1310
The war on health freedom has a new battle developing.
Stop Durbin Now: Senator Durbin, the Number 2 democrat of the United States Senate has launched a new battled against the dietary supplement industry. S. 1310 the Dietary Supplement Labeling Act of 2011 can only spell trouble for the industry and quick, decisive and sustained action by the entire community from consumers to industry leadership is going to be needed to stop him. Senator Durbin, whose leadership position is often referred to as the Democratic Whip, has for many years attempted to undermine the hard won victories of Proxmire, NLEA, and the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Durbin Wants to Give the FDA Even More Power: Just as the Senate was leaving Washington for the July 4th holiday, Senator Durbin (D-IL) and Senator Richard Blumenthal (D-CT) issued a press statement announcing this new legislation. According to press accounts, Senator Durbin is seeking the FDA to draw a strong line between dietary supplements and food additives, the Durbin/Blumenthal "legislation would require FDA to establish a clear definition of which products are foods and should be regulated as such and which products are meant to be health aids and should be regulated as dietary supplements."
Camel's Nose Under the Tent of DSHEA: In typical Durbin fashion, the press statements and the actual text of the legislation tell different stories. Senator Durbin is using his gripe with MonsterTM drinks and melatonin bars as the camel's nose under the tent to chip away at the founding principles of food law as they relate to dietary supplements.
S. 1310 Would:
- " Add Additional and Burdensome Registration Requirements for Manufacturers;
- " Seek to Supersede US Law with the Implementation of a European Union Style List of food ingredients and products which can be sold as supplements ; and
- " Be the Death Knell for Proprietary Blended Products
Dietary Supplements and other Food are Already Heavily Regulated: All foods including dietary supplements are already heavily regulated. The laws on the books are sufficient. Take part in Stopping S. 1310. Send a message to your Senator to tell them to Stop Durbin's S. 1310.
Only by working together are we going to keep quality products in the marketplace.
Take Action Now. Click Here for Letter to send your Senator.
April 2011
Court Finds the FDA Violated the Constitution
Fax Your Letter to Chairman Kingston Today
The ongoing constitutional fight of the health freedom community scored a partial victory in April 2011. Since the Clinton Administration, Durk Pearson and Sandy Shaw with attorney Jonathan Emord have challenged the Food and Drug Administration (FDA) in court on violations of the US Constitution regarding health claims and dietary supplements.
The latest decision, out of the US Court District Court found that the FDA violated the First Amendment of the Constitution (Freedom of Speech) by denying two health claims related to the ability of antioxidant vitamins to reduce the risk of cancer. One of the tactics the FDA has used is to change the language submitted by a company to so dilute it with disclaimers as to make it meaningless. This victory comes on the heels of another victory in October 2010 in which the court ruled that the public may be told that "selenium may reduce the risk" of prostate, colon, bladder, or thyroid cancer.
The original legal challenge in the early 1990s known as Pearson Versus Shalala forced the FDA to clarify their significant scientific agreement standard for authorizing health claims and to develop mechanisms for dietary supplement claims when this standard is not met. Even with this initial victory, a clear declaration by the courts that the FDA was abridging free speech by rejecting qualified health claims of dietary supplements, the agency has not modified its practices to comply with the Constitution and the Courts. Instead, the FDA has dragged the court proceedings out for years (at taxpayer expense) and multiple lawsuits with varying co-plaintiffs joining with Pearson and Shaw.
Congress intended for consumers to be informed about the true health benefits of food and dietary supplements. In 1990, Congress enacted Nutrition Labeling and Education Act (NLEA). While it gets less attention than the Dietary Supplement Health and Education act of 1994 (DSHEA) it is no less important. NLEA created a 'safe harbor' for foods and dietary supplements from a 'drug' designation by the FDA when making a health claim. The pathway to making such a claim was intended by Congress to be easier to achieve than the drug label approval process. The FDA now for 21 years has failed to fully and fairly implement NLEA instead rejecting claims or changing them so much as to make them meaningless. The courts have been clear, "where the evidence supporting a claim is inconclusive, the First Amendment permits the claim to be made; the FDA cannot require a disclaimer that simply swallows the claim."
It is time that we asked Congress to reprimand the FDA and instruct them to fully and fairly implement NLEA, comply with the court and modify its health claim approval process so as not to violate the Constitution. Please download, sign and fax this letter which will be personally delivered to the Chair of the House Appropriations Subcommittee that handles the FDA's budget and other key Appropriators.
1Statement in Memorandum Order signed by US District Judge Beryl A. Howell in Civil Action No. 09-1546 (BAH) on 13 April 2011 (page 35), http://www.courthousenews.com/2011/04/15/Supps.pdf
| Protecting Your Food Supply Choices |
Health Freedom and the Food Supply
The desire for Americans and our global neighbors to maintain liberty has never been stronger than it is as we enter April 2011. The focus on health freedom is a cornerstone of that liberty. What happens in the agricultural community directly affects consumers' access to quality dietary supplements as dietary supplements are foods.
Budget Battle: Washington is embroiled in budget battles that will go on for months. The hard truth that we as a nation are grappling with is that for every dollar being spent by the United States Government, 45 cents of it is borrowed. This is called deficit spending. There are only two ways to solve deficit spending - to decrease spending or to increase income. Increasing the income of the United States means raising taxes, and the 50% of Americans who pay taxes in this country are not okay with that. We've seen the size of government grow dramatically, with more than 100,000 federal jobs created and massive government programs like health care reform be enacted into law. All of the economic experts and most Americans understand this is not sustainable.
Families around the world are feeling the crushing weight of increased food and fuel prices. In the United States, food prices have gone up about 8 %. In North Africa and Middle East, countries such as Syria, Egypt, Tunisia, Bahrain, Jordan, and Libya have seen food prices skyrocket, more than 25% in under a year. It is a contributing factor to the instability of these countries. Food shortages are not uncommon. Just a few years ago, the Codex Alimentarius instructed its member countries to pass food control legislation (which in the US called food safety) and something. Increased regulations contribute to increased pricing as companies always pass the additional costs on to the consumer.
Health Freedom Cannot Fall by the Wayside: Health freedom is not just a battle to protect access to dietary supplements. The right to maintain control of your own decision making in health including in the foods you purchase is as key to liberty as freedom of speech. The founders of this great nation wrote of the right to life, liberty and the pursuit of happiness. Nutritional liberty including informed consent through proper labeling and maintaining an active free market with expanded choices are essential.
Food Safety Battle Continues: During the last few years as the federal government has sought to expand its regulatory powers for the food supply, the USDA has announced it will in essence deregulate certain GM products. The announcement in January that the USDA will allow the unrestricted commercial cultivation of GM alfalfa sees has many in Congress and the public outraged. The environmental impact statement recently released is inadequate. Alfalfa is the 4th largest crop planted in the United States and the hay it produces is used to feed cattle and horses.
American consumers and farmers like our global neighbors have rejected the industrial push for genetically modified (GM or GMO) seeds and continue to fight tough battles to keep these seeds away from agricultural communities especially organic farms. Everyone desires clear and accurate labeling on foods, including GM foods including meats from animals fed GM grains. The public has also rejected the concept of mandatory irradiation of their foods, including organic foods (even herbs). There is a broad consensus among the public that if GM foods are going to enter the market place, and if foods are irradiated, that they ought to be truthfully labeled. The consumer should be accurately informed and be given the liberty to make their own choices.
Attempts at one size fits all regulation in agriculture, puts many small, local, and specialty farms at risk for elimination. Americans want raw foods including herbs to truly be raw. In addition to the irradiation battle farmers have been challenged with, now forced pasteurization is being forced upon more industries than just the dairy industry. Most consumers do not realize that when they pay extra for eggs that are organic, when there is an ink stamp on the egg, it means the eggs were heated up.
Keep in mind, if an organic herb farmer is forced to compromise their techniques through onerous government regulations, then the dietary supplements that are made from those herbs are compromised as well. At every turn, government gives the appearance of ignoring the desires of the public as it relates to protecting organic and promoting techniques and products the public opposes.
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Genetically Modified Foods
Genetically modified (GM) or engineered foods affect the entire food supply including dietary supplements. The risks are not fully understood. Consumers and farmers alike oppose their broad adoption. During the last few years as the federal government has sought to expand its regulatory powers for the food supply, the USDA has announced it will in essence deregulate certain GM products. The announcement in January that the USDA will allow the unrestricted commercial cultivation of GM alfalfa sees has many in Congress and the public outraged. The environmental impact statement recently released is inadequate. Alfalfa is the 4th largest crop planted in the United States and alfalfa hay is used to feed dairy cattle and horses.
GM Alfalfa - the battle rages on: One of the most pressing issues that the USDA has not resolved for GM foods is product drift. Organic farmers say their crops and their livelihoods can be damaged by pollen drifting from neighboring fields. Crops cannot qualify as organic, and the premiums often accompany the designation, if they contain GM material. The National Organic Coalition says all GM crops should be regulated and there should be a ban on GM corn, sugar beets, alfalfa and canola and other GM crops "too promiscuous to prevent GM contamination."
In March farmers and a number of consumer groups filed a lawsuit against the USDA stating the approval of the unrestricted planting of GM alfalfa seeds is unlawful because it will according to their own data lead to a dramatic increase in the use of toxic herbicides. "USDA data show that 93% of all the alfalfa planted by farmers in the U.S. is grown without the use of any herbicides. With the full deregulation of GE alfalfa, USDA estimates that up to 23 million more pounds of toxic herbicides will be released into the environment each year."
Genetically Engineered Salmon: A genetically engineered salmon is likely to be sold in the United States in the near future. This salmon has higher hormone rates in than wild salmon and the risks to humans is not fully understood. Unless the FDA changes its current policies, the industry would be allowed to market these salmon without any notification on the label that it is GE salmon. This labeling issue is at the core of consumers' concerns.
Legislation:
H.R. 521 and S. 2230 introduced by Congressman Don Young of Alaska and Senator Mark Begich to prevent the FDA from approving genetically engineered fish.
These same legislators introduced H.R. 520 and S. 229 to "deem a food to be misbranded if it contains genetically-engineered fish unless the food bears a label stating that it contains genetically-engineered fish."
There are only a few sponsors of these bills to date. Click Here for the attached letter of support for these bills.
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The European Union Continues is Regulatory Assault
on the Natural Health Community
With signature of the Treaty of Maastricht in 1992, the European Union Treaties were begun and the concept of a 'super nation' with one currency (the Euro) and open borders among member countries was born. This was done for political and economic purposes. Citizens of each member country (originally the United Kingdom of Great Britain and Northern Ireland, France, Spain, Italy, Belgium, Denmark, Germany, Greece, Ireland, Luxemburg, the Netherlands, and Portugal) also have EU citizenship.
In addition the European Union formed a new layer of legislative, administrative, regulatory, and judicial bureaucracies and gained its own seat at the table in international bodies such as the United Nations and CODEX. As part of this the EU Parliament and Commissions began developing laws and regulations to harmonize the member countries' regulations.
While traditional health systems, sometimes referred to as complementary and alternative medicine (CAM) and natural health practices have often flourished and been widely practiced in countries of the European Union, over the last two decades there has developed a decidedly "anti" CAM attitude among regulators. This is in part due to the widespread popularity and increased media discussion, and potentially as a perceived threat to the large and powerful pharmaceutical companies, many of whom originated out Europe. The same mindset that always existed within the US FDA, desiring to force dietary supplements into the patented pharmaceutical pre-market approval process exists within the EU without great defenders such as Senators Orrin Hatch and Tom Harkin in the EU Parliament and Commissions to promote and protect the position of consumers and health freedom advocates.
In 2004 the European Union (EU) established directive 2004/24/EC on Traditional Herbal Medicinal Products to provide a regulatory process for the approval of what they call herbal medicines within the EU countries. Previously the regulation of these products was handled by the individual member countries. The 2004 regulation required Distributors never before marketed herbal products to obtain an authorization to market within the EU and gave companies who were already marketing products in member countries until 20 April 2011 to obtain authorization. (A copy of the actual Directive can be found here).
It is important to note that the terminology used in EU directives related to herbal products is not exactly the same as that used by US legislators. The EU has taken a very harsh stand that herbal products are medicines (i.e. not dietary supplements which is a victory for those with the mindset that would like to treat all products like pharmaceuticals.)
The EU directive requires that companies demonstrate that safety and efficacy of the herbal product through traditional use within the EU for at least 30 years or 15 years within the EU and 30 years outside the EU.
It is important to note that "the only herbal medicines that are exempted from the provisions of the Traditional Herbal Medicinal Products Directive are those unlicensed remedies that are made up for a patient following a consultation with an herbalist."
The EU implemented a good manufacturing practices (GMP) requirement for all herbal products as well.
According to the Directive, these herbal products must meet the following key eligibility criteria:
- Must be administered orally, externally, or by inhalation are suitable.
- Products intended for use without supervision by a medical professional
- The intended use of an herbal medicine will only be authorized on the basis of its traditional history and/or the recognized pharmacological properties of the herbal ingredient(s).
- Vitamins and minerals may be added to the herbal medicine provided that their use is ancillary to the herbal ingredient(s)
- If the competent EU member judges that the herbal medicine fulfills the criteria for a marketing authorization, then an authorization under Traditional Herbal Medicines Product Directive should be granted.
- Herbal medicine products manufactured using isolated active ingredients from plants will not be regarded as herbal medicines and will not receive an authorization under this scheme.
The Traditional Herbal Medicines Product Directive does allow medicinal claims to be made on the label of the final product, although restrictions do apply on the final wording.
The Public Realized that the 11th Hour Has Arrived: With the deadline just weeks away, there are currently a number of online petitions in an attempt to stop the implementation of these regulations. The only way this law can be delayed or changed is by an act of the EU Parliament. EU citizens and organizations currently operating in the EU or with member companies in the EU are the organizations that will need to exert their political power to affect any change.
Companies that have not yet complied with the regulatory requirements must either comply or exit the market place.
The Traditional Herbal Medicine Product Directive is secondary to the onslaught of restrictions placed on dietary supplements in general within the EU.
The EU calls dietary supplements, 'food supplements' and defines them as concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. They are marketed 'in dose' form i.e. as pills, tablets, capsules, liquids in measured doses etc.
In 2002, The European Parliament and Council passed Directive 2002/46/EC established harmonized rules for the labeling of food supplements and introduced specific rules on vitamins and minerals in food supplements. There was a push to create a 'positives' list and the EU annexed the directive with a list of permitted vitamin or mineral preparations that may be added for specific nutritional purposes in food supplements.
The EU Commission issued an additional Directive (2006/37/EC) and Regulation (1170/2009) to expand the list of substances. Beginning in 2005, products that contained ingredients that were not on these approved lists were barred from the marketplace in EU countries. Products already in the marketplace were given until December 2009 to submit a dossier of safety and efficacy data to gain approval.
After curtailing products in the marketplace, the next action to further restrict access to nutritional supplements has been in the setting of maximum and minimum limits on vitamin and minerals in products.
The Citizens of the European Union have access to far fewer dietary supplements than the Americans. Unless they take action, their access will continue to diminish by increasing restrictions on the potency of products.
That the EU chose not to simply grandfather in products that have been in the marketplace for years, instead requiring what equates to a re-approval process which will discriminate against many high quality smaller companies. It is likely that the large corporations, may have the financial capacity to prepare the required documentation required to have their products approved, but will likely not put the effort forward for their entire product lines. This regulatory burden which eliminates products from store shelves will likely backfire and lead to a thriving black market environment for favored products where quality control measures will not be in play.
March 2011
The focus of Codexfund.com activities is to insure that neither the Congress, any US Federal agency (such as the FDA or FTC) nor an International Rulemaking body (such as the Codex Alimentarius Commission) takes any action that restricts or impedes access to dietary supplements.
For too long, the dietary supplement community has operated from a defense posture, only taking action in response to an attack. 2011 is a time to move into an offensive position instead. We seek to further educate Congress and policymakers and reaffirm:
- Consumers feel strongly about health freedom.
- Consumers feel strongly about preserving and promoting their rights to continued access to the foods they choose, including dietary supplements.
- Consumers desire Congress to remain vigilant and act as needed to protect their health freedom, access to dietary supplements, and freedom of speech.
112th Congress
The November 2010 elections sent a clear message to Washington that Americans value liberty and limited government. Americans want the government to reduce spending so that it is no longer borrowing 45 cents of every dollar it spends. Unemployment is high, food costs are rising and fuel prices are skyrocketing. Lawsuits by various states on Obamacare as the health reform law is known are likely to end up before the Supreme Court.
The 112th Congress has a Senate with Democratic majority and a House with Republican majority. Having netted 63 House seats in the November midterms, the Republicans are going into this session with a solid 242-193 majority over the Democrats. In the Senate however, the Democrats have managed to hold onto control and will gavel-in with 53 seats to the Republicans' 47.
It promises to be an interesting Congressional session. We have many new members to educate about health freedom, CODEX and dietary supplements.
Food Safety Bill Becomes Law
CodexFund.com has reported throughout the 111th Congress Congressional action on food safety legislation that was introduced after a number of food safety alerts across the United States. In late December, after some slick political maneuvering HR 2751, originally entitled, Consumer Assistance to Recycle and Save Act, was renamed the FDA Food Safety Modernization Act and passed the Senate under Unanimous Consent.
Thanks To Your Efforts, Dietary Supplements Were Protected by Congress
Civic Participation Does Make a Difference! While many felt the food safety bill inserts government too much into the food industry, and was too costly, the final bill much better bill than the one that was introduced, especially for supplements. That is directly because of all the faxed letters you send and the telephone calls you made.
CODEX Guidelines Cannot Simply Be Adopted
As a result of the consistent and persistent grass roots efforts of the Codexfund.com and other organizations, a year ago, Senators Tom Harkin and Orrin Hatch confirmed during Committee proceedings that the US Food and Drug Administration (FDA) were not allowed to simply to adopt or harmonize recommendations of the Codex Alimentarius Commission. They confirmed that only Congress could change the laws as they relate to dietary supplements. This was a great victory for us.
Additionally, the final bill exempts dietary supplements from the provisions on international harmonization.
To reach the full report, please click here.
December 31at, 2010
Food Safety Bill to Become Law in 2011
(28 December 2010) Several weeks ago, S. 510 passed the Senate but was found to have an unconstitutional provision and thus did not move swiftly to the House for passage. By most accounts, food safety was considered a dead issue in the waning days of the Lame Duck session of the 111th Congress.
However, in a surprise maneuver by Senate Majority Leader Harry Reid, food safety legislation was passed under a unanimous consent procedure on Sunday, December 19, 2010. Some are reporting that as few as two senators were in the Chamber at the time.
Senator Tom Coburn, the lone hold out to the Bill, who repeatedly stated his objections to S. 510 negotiated on a bigger picture issue - and did not object to the final passage. As we learned the next day, the Senate Democrats had the votes to pass a Continuing Resolution with the food safety tacked on, opening the door for hundreds of other ear marks to be added on. Sadly, only Senator Coburn was holding out on the Republican side, so with minor revisions that will be reported below, HR 2751 passed the Senate by a voice vote of Unanimous Consent. The negotiation was, to pass a modified version of S510 on another House bill in order to satisfy the Parliamentarian. This move saved tax payers billions in ear-marks this fiscal year.
In what was technically a legal maneuver, but by many American's perspectives, a slick political maneuver, HR 2751, originally entitled, Consumer Assistance to Recycle and Save Act was used as the vehicle to pass food Safety. The Senate leadership took HR 2751which has originated in the House so they could resolve the constitutional provision that requires all bills that create new taxes come from the House, they changed its name to FDA Food Safety Modernization Act and removed all the provisions of the original bill which was to "…accelerate motor fuel savings nationwide and provide incentives to registered owners of high polluting automobiles to replace such automobiles with new fuel efficient and less polluting automobiles" and converted it to the Food Safety Bill.
The original version of HR 2751 focused on fuel recycling had passed the House in June 2009 with a vote of 298 to 119. The Senate passed the revised HR 2751 and returned it to the House for passage, no conference process took place. Instead, the House voted and passed HR2751 after one hour of debate by a vote of 215to 144. The Bill has been sent t the White House for signature by the President to make it public law.
Ripped from the Headlines Legislation
CodexFund.com has reported throughout the 111th Congress Congressional action on food safety legislation that was introduced after a number of food safety alerts across the United States. This type of legislation can be known as 'ripped from the headlines' legislation because the stories in the media about tainted spinach, tainted eggs, and adulterated products from China were used in concert with the behind the scenes push by FDA supporters who want to see the agency get more power and staff to get Congress to act. What gets lost in most of these discussions is typically, the issues arose as a result of a failure for those in positions of authority to do fulfill their duties. Using the egg recall as an example, one government agency who inspected the farm in which the eggs were produced in unsanitary conditions, failed to notify the FDA who had new broader authorities under the recently finalized egg production regulations. Furthermore, the concerns about products imported from China are not new concerns. These concerns have been expressed for two decades, and the authority to inspect imported food products existed through these two decades. What did not exist was the will by the authorities to be more aggressive with imported food inspections and implement existing laws.
Standing Up For US Law
As a result of the consistent and persistent grass roots efforts of the Codexfund.com and other organizations, a year ago, Senators Tom Harkin and Orrin Hatch confirmed during Committee proceedings that the US Food and Drug Administration (FDA) were not allowed to simply to adopt or harmonize recommendations of the Codex Alimentarius Commission. They confirmed that only Congress could change the laws as they relate to dietary supplements. This was a great victory for us. Throughout 2010, we have educated legislators about your concerns with proposed food safety legislation. We worked hand in hand with key legislative staff and members to make improvements, and to remove deleterious provisions. We repeatedly delivered thousands of letters throughout the year to alert Senators about concerns with S. 510, the food safety bill. These efforts were important in stemming the tide of those who were pushing from the pro-government control positions.
Nine months into 2010, Senator Harkin introduced a revised version of S. 510 known as the Manager's Amendment. In this revision, a seemingly minor edit, with major implications was made regarding Codex. Section 306 for example originally included a provision which called for the Secretary of Health in coordination with the Secretary of Agriculture and other agencies to "develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments, and their respective food industries, from which foods are exported to the United States" to include, "Recommendations to harmonize requirements under the Codex Alimentarius." . Because of your efforts, the Codex provision was changed to read, "Recommendations on whether and how to harmonize requirements under the Codex Alimentarius." This tiny edit means that harmonization with Codex on all food categories is not automatic. A subsequent conforming amendment detailed below again reiterates that no harmonization activities can undermine DSHEA.
Objections to the Bill reached across many constituencies. The health freedom/dietary supplement community was the first to speak out. They were followed closely by the small farmers, organics community, and after both Bill O'Reilly and Glenn Beck talked about the issue, even the Tea Party began voicing concerns. Objections included the cost, the growth of government, and the reality that expanding government regulations affects small businesses adversely and will also drive the cost of food higher. The affect on road side food stands and Farmer's Markets was addressed
The Final Food Safety Bill
There was one change from the Bill that originally passed the Senate and that which was passed under HR 2751. In Section 743, a limitation on the use and amount of fees the FDA can charge related to issuing food exportation certificates.
The Congressional Research Service Provided the following summary of the Bill:
FDA Food Safety Modernization Act - Title I: Improving Capacity to Prevent Food Safety Problems - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the food safety activities of the Secretary of Health and Human Services (HHS), including to authorize the Secretary to inspect records related to food.
Exempts certain establishments that sell food directly to consumers, such as roadside stands, farmers markets or participants in a community supported agriculture program, from specified requirements of this Act.
Requires each owner, operator, or agent in charge of a food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by such facility. Sets forth provisions governing exemptions from such requirements for certain facilities.
Requires the Secretary to: (1) issue guidance documents to reduce the risk from the most significant foodborne contaminants; and (2) establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks. Authorizes the Secretary to issue exemptions and variances from such standards.
Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection.
Directs the Secretary to develop voluntary food allergy and anaphylaxis management guidelines for schools and early childhood education programs.
Title II: Improving Capacity to Detect and Respond to Food Safety Problems - Requires the Secretary to: (1) allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food; and (2) establish a product tracing system to track and trace food that is in the United States or offered for import into the United States.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses.
Gives the Secretary the authority to order a recall of an article of food.
Title III: Improving the Safety of Imported Food - Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded.
Requires the Secretary to establish a program to expedite review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such program.
Authorizes the Secretary to: (1) require a certification that an article of food imported or offered for import complies with applicable requirements of this Act; and (2) enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Requires food to be refused admission into the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent or the foreign country.
Sets forth provisions governing the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that foreign entities meet applicable FFDCA requirements for importation of food into the United States.
Title IV: Miscellaneous Provisions - Authorizes appropriations for FY2011-FY2015 for the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration (FDA). Directs the Secretary to increase the field staff of such Centers and Office.
Establishes whistleblower's protections for employees of entities involved in the manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food who provide information relating to any FFDCA violation.
Without question, this Bill gives the FDA a lot more power than most citizens are comfortable with. Furthermore, it will be expensive and grow the size of the FDA staff tremendously. FDA is expanding its reach onto foreign soil and creating massive databases of information about every aspect and organization involved with the growth, manufacture and production of food ingredients and products. There will be massive new paperwork requirements for businesses to comply with, and fear that once the FDA does one inspection they will insist on re-inspections, which the business will have to pay for. The cost of food products for consumers many of whom are struggling to survive will most certainly rise. Furthermore, the expanded levels of bureaucracy may cost jobs and mean the end of some small businesses who cannot stay afloat while conforming to the new law.
Dietary supplements were specifically mentioned in several sections of the law. This information is provided below.
Dietary Supplement Specific Language
While all food regulations also effect dietary supplements, unless they are specifically exempted, the following language in the new law is specific to dietary supplements.
New Dietary Ingredients
Since the passage of DSHEA in 1994, the FDA has failed to publish guidelines on new dietary ingredients. Section 113 addresses concerns of a number of legislators regarding steroids being marketed as supplements.
''(c) NOTIFICATION.-
''(1) IN GENERAL.-If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has.
''(2) DEFINITIONS.-For purposes of this subsection- ''(A) the term 'anabolic steroid' has the meaning given such term in section 102(41) of the Controlled Substances Act; and
''(B) the term 'analogue of an anabolic steroid' means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.''.
(b) GUIDANCE.-Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.
International Harmonization Issues Will Not Affect DHSEA
In Section 305, entitled Building Capacity of Foreign Government with Respect to Food Safety, a clarification again was included that DSHEA is protected.
SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO FOOD SAFETY.
(a) IN GENERAL.-The Secretary shall, not later than 2 years of the date of enactment of this Act, develop a comprehensive plan to expand the technical, scientific, and regulatory food safety
capacity of foreign governments, and their respective food industries, from which foods are exported to the United States.
(b) CONSULTATION.-In developing the plan under subsection (a), the Secretary shall consult with the Secretary of Agriculture, Secretary of State, Secretary of the Treasury, the Secretary of
Homeland Security, the United States Trade Representative, and the Secretary of Commerce, representatives of the food industry, appropriate foreign government officials, nongovernmental
organizations that represent the interests of consumers, and other stakeholders.
(c) PLAN.-The plan developed under subsection (a) shall include, as appropriate, the following:
(1) Recommendations for bilateral and multilateral arrangements and agreements, including provisions to provide for responsibility of exporting countries to ensure the safety of food.
(2) Provisions for secure electronic data sharing.
(3) Provisions for mutual recognition of inspection reports.
(4) Training of foreign governments and food producers on United States requirements for safe food.
(5) Recommendations on whether and how to harmonize requirements under the Codex Alimentarius.
(6) Provisions for the multilateral acceptance of laboratory methods and testing and detection techniques.
(d) RULE OF CONSTRUCTION.-Nothing in this section shall be construed to affect the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417).
Section 103 -Hazard Analysis
The hazard analysis and extensive documentation requirements of Section 103 do not apply to dietary supplements.
(g) DIETARY SUPPLEMENTS.-Nothing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).
Exemptions Can Be Lifted
While small businesses, farmer's markets, road side stands and dietary supplements were exempted from certain provisions, the Congress included an exemption to the exemption.
In the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under this subsection.
What Can We Do Now?
There will over the next few years be a series of public meetings and proposed rules issued to implement this law. Codexfund.com will monitor these activities, keep you informed and alert you when and how to take action to have your voice heard.
With more than 50 new members of Congress coming to Washington in January, we will be busy educating and re-educating legislators and staff about issues that matter to Codexfund.com supporters. We are developing a proactive legislative agenda for the 112th Congress which we will share early in 2011. Our goal is to facilitate a course correction within statutes and regulations to favor the citizenry. Remember we are a government, 'of the People, by the People, and for the People'. Our desire is to implement that as it affects dietary supplements and health freedom. Your thoughts on this are always welcomed.
2011 New Years Website Update
With the launch of a new legislative year, and to prevent confusion, we will be archiving much of the information from the last year and launching a revised site shortly. If you have ideas or information you would like to see included, please let us know by emailing info@codexfund.com.
The CodexFund.com was formed in 2009 as an activity to bring together all parties interested in maintaining and promoting health freedom in particular as it relates to dietary supplements and complementary and alternative health practices.
A primary concern, through which our name was drawn, is the Codex Alimentarius Commission, an activity of the United Nations begun in the early 1960s to ensure food safety and fair practices in food trade.
The food standards, guidelines and related texts such as codes of practice are increasingly being drawn upon as the basis for regulations.
In the matter of dietary supplements, the CODEX Commission has become a vehicle through which those who desire to reduce access to vitamin and mineral dietary supplements have operated. As a result, many countries around the world, in particularly in Europe. Consumers have far fewer products available to them in the marketplace.
CodexFund.com has actively worked to insure that Congress stands strong in protecting and promoting health freedom and insuring the protection of the hard won victories in dietary supplement legislation such as the Proxmire Amendment and the Dietary Supplement Health and Education Act of 1994.
Working together as a community, we can maintain and promote health freedom.
December 9th, 2010
Alert on Food Safety
Call Your Senators Friday and Monday
- Demand a NO vote on Cloture to the Continuing Resolution.
The House Representatives on Wednesday voted along party lines to pass a Continuing Resolution to keep the government running through Fiscal Year 2011. They have not as you may recall passed even one of the appropriations bills that is their job to do each year. Without a Continuing Resolution the government officially shuts down.
In an extremely unusual move, the House inserted food safety legislation into the Continuing Resolution. Many spoke against this measure, and the vote was close.
The next step in the legislative process is for the Senate to vote on this Continuing Resolution. The Senate procedures call for a vote on Cloture, which would limit debate on the Senate floor. To get cloture, 60 votes are needed. To stop this forward motion of the Food Safety legislation, we need to get 41 Senators to Vote NO on Cloture. If cloture is not reached, the Senate will not vote on the Bill.
We Need You To Call Your Two Senators Friday.
Message: "Vote No on Cloture for H.R. 3082, Making Further Continuing Appropriations for Fiscal Year 2011 and the Food Safety Enhancement Act."
Click Here for a list of your Senators.
December 6th, 2010
Constitutional Violation Blocks Forward Motion on S. 510
While the Senate voted to pass the newer version of S. 510, the Bill may not actually make it to the President's desk for signing into law this year after all. We are now learning that Senate staff were informed from the outset that the 'reinspection fees' provision of S. 510 violated the Constitutional provision that states that all tax provisions (any provision in legislation that levy's fees) must begin in the House of Representatives.
Typically there would be a Conference process where members of the House and Senate of both parties would sit down and work through the differences in the two Bills. However, because the Congress is running out of time, (the 111th session of Congress ends at the end of 2010) the leadership determined they would side step this process and simply send S. 510 to the President.
This is not a new or unusual sidestepping, but typically only happens when there is no controversy attached to legislation. The rules that govern the parliamentary procedures allow for such an action, but with the Constitutional violation, this is not possible.
Keep in mind, the conference process would have been arduous and filled with opportunities to make the Bill unpassable in either the House or the Senate because the House food safety bill passed earlier this year is completely different than the Senate version. As one staffer said, "they are similar in name only".
The issue is not dead however; there is much negotiations going on between the House and Senate Leadership. One discussion is to introduce S510 with a House number and to pass it quickly. There is not as yet agreement to do this because with the fee provision, both the Energy and Commerce and the Ways and Means Committees have to vote it out of Committee and so far, the Ways and Means Committee is rejecting the Senate created language. Keep in mind that this Committee sees more than just this Bill affected. Such a move would in the minds of some, undermine their Constitutional authorities and lessen their power.
Congress will remain in session probably right up until Christmas and is entrenched other matters related to the Bush era tax cuts that expire at the end of the year, the unemployment benefits extension issue, and the military's Don't Ask, Don't Tell Policy.
While the Bill that passed was much better than what we started with in 2009, the core issues of expanding FDA's authorities. We cannot assume that S. 510 is dead. We will keep you posted.
November 24th, 2010
Act Now – Call Your Senators and Urge to Vote NO on S. 510
S. 510, Food Safety Legislation is slated to come to a vote on the Senate floor on Monday, November 29. While the bill has been improved from a year ago, it still provides an expansion of government into the lives and decisions of Americans regarding foods, farming, and dietary supplements. This bill includes provisions that authorize the government to map the entire food production system and to track every food product you purchase, every dietary supplement you purchase.
This Bill is expensive, intrusive, and will not make the food supply safer. It will however compromise your liberty and privacy while driving the costs of foods (including supplements) higher.
We made major progress last year in getting Senators Hatch and Harkin to clarify that the FDA cannot adopt CODEX guidelines affecting dietary supplements without Congressional approval, but it has not stopped the discussion on harmonization of food standards internationally. It is important to keep in mind that behind the scenes orchestrating ‘food safety’ legislation in the United States is a strategic plan of the UN’s Codex Alimentarius Commission for every nation to develop “national food control systems’ including legislation on food safety and which promote and adopt Codex Guidelines. The fabric of America does not include ‘food control’ laws, but that is exactly what S. 510 launches.
We have a chance to stop this Bill before it becomes law. Call your own two Senators (click here to see the list in a new window). If we can convince 51 Senators to vote NO on S. 510, Victory is ours. A * in the last column means they are a Republican that voted yes on the motion to proceed and should also be called to encourage a NO vote.
Please check out www.codexfund.com for updates. If you have any questions of updates to provide based on your calls to the Senate, email them to Beth Clay at bclay@dc-strategy.com.
October 2010
June 10 Presidential Executive Order 13544
Not a Crisis - But Cause for Continued Monitoring
CodexFund.com has been contacted by numerous individuals concerned by internet stories that make statements like, "Obama Implements Codex Alimentarius by executive order - This effectively makes herbs, alternative medicine, backyard gardens, and many other things illegal." or "Obama signs legislation to make supplements and alternative remedies illegal."
These stories are factually inaccurate and sadly create 'the sky is falling' stress when a calming steady perseverance is called for. On June 10, 2010, President Obama President signed, an Executive Order Establishing the National Prevention, Health Promotion, and Public Health Council which is part of the implementation of the new health care law, often referred to as 'Obama Care'. This Executive Order does not implement Codex and does not make dietary supplements or alternative therapies illegal.
Does the Council and the new law create potential problems for the health freedom, natural health communities?
Yes. This is part of the bigger movement to put government in charge of all health decisions. When that happens, liberty is compromised and natural, alternative, and otherwise non-main stream therapies and products are often marginalized.
The National Prevention, Health Promotion, and Public Health Council is being organized to set the framework for providing coordination and leadership at the Federal level, and among all executive departments and agencies, with respect to prevention, wellness, and health promotion practices, the public health system, and integrative health care in the United States. It will also offer recommendations on incorporating the most effective and achievable means of improving the health status of Americans and reducing the incidence of preventable illness and disability in the United States. Further it is required to provide recommendations to the President and the Congress concerning the most pressing health issues confronting the United States and changes in Federal policy to achieve national wellness, health promotion, and public health goals, including the reduction of tobacco use, sedentary behavior, and poor nutrition; as well as consider and propose evidence-based models, policies, and innovative approaches for the promotion of transformative models of prevention, integrative health, and public health on individual and community levels across the United States.
Engaging in the Process is Essential
Too often, the natural/alternative health communities do not engage in the entire process, but come in at the 11th hour. We have for the first time in many years the opportunity to be engaged from the inception of this activity. We need to be factually accurate and reasoned in our presentations while maintaining the values of our community and personal perspectives.
If we do not actively engage in the public forum input that will be a major thrust of this activity, then we are likely to see the terms "science-based" and "evidence-based" used as a means of excluding some of the most effective natural and traditional approaches to healing.
Furthermore, if we do not actively engage in every aspect of this activity, it is not impossible to see recommendations put forward on certification and licensure and changes to the regulations on dietary supplements, homeopathy, and other natural healing practices. We must make sure we prevent this forum being used to attack the community or to reduce access to care and products. If we are wise and consistent, we can show the value and the cost savings opportunities.
CODEX Has Not Been Implemented by Executive Order
As to the references in these Internet stories to CODEX, there is nothing at all in this Executive Order that points to CODEX. We have on the record from Senators Harkin and Hatch that the Administration may not implement any provision of CODEX regarding dietary supplements without first obtaining Congressional approval. And given the precedent set by Mrs. Obama, backyard gardening is being promoted by this White House. There is legislation pending that addresses food safety. It appears to be stalled. If this should change, you will be alerted at the Codexfund.com website.
We will keep you informed about this and other Administration and legislative activities that may affect your health freedom and access to dietary supplements. Check back regularly to www.codexfund.com for the facts. Click here to view the Executive Order.
August 2010
Good News About Dietary Supplements in Health Promotion
A majority of Americans use dietary supplements. Too often the headlines are filled only with negative findings. There is a lot of good news about the benefits of using dietary supplements. Our first focus as we launch this segment of our website is on the 'Sunshine Vitamin" Vitamin D.
Vitamin D: Studies around the world are showing an increasing world -wide trend of Vitamin D deficiency. This includes the United States and all age groups.
Vitamin D has many benefits such as helping our bodies absorb calcium as well as playing a major role in the development and maintenance of strong bones.
Researchers from the Georgia Prevention Institute studied a group of black teens and found that supplementing with 400 IU of vitamin D per day was not sufficient. Their study found that 2,000 IU was needed daily. After 8 weeks vitamin D sufficiency was achieved. The researchers measured arterial stiffness and found the vitamin D supplementation at 2,000 IU offered greater arterial flexibility. This is direct evidence that the 2000 IU a day may protect vascular systems.
According to a recent article by Dr. Ernest Levister Jr., "studies have linked Vitamin D deficiency to a number of serious health problems, including heart disease, several types of cancer, osteoporosis, diabetes, Alzheimer's disease and some autoimmune disorders. Low levels of Vitamin D are even associated with high blood pressure.
There is new enthusiasm with Vitamin D studies showing that it does boost the immune system and fight off viral infections such as flu and at the same time tempers the immune system from overworking, which can create more mucus and fluids in the lungs, causing further problems such as pneumonia." He goes on to state, "Vitamin D signals the intestines to absorb calcium. With low levels of Vitamin D, the body will break down bones to get the calcium it needs. Without enough Vitamin D, the body cannot absorb enough calcium to satisfy the body's need, no matter how much calcium you consume in food supplements." He concludes his article by stating, "…many experts recommend adults take 1,000 to 2,000 units a day, an amount only possible to get though supplements." (blackvoicenews.com, 2010)
Dr Mehmet Oz often talks about the importance of Vitamin D on his top rated television show. He says that as many as 60% of his viewers are likely Vitamin D deficient and specifies that the type of Vitamin D supplement that should be taken is Vitamin D3.
Another recent study looking at senior citizens requiring home care, found that only 35% had sufficient levels of Vitamin D. Those with sufficient levels "… had better cognitive performance on the tests than those in the deficient and insufficient categories, particularly on measures of "executive performance," such as cognitive flexibility, perceptual complexity, and reasoning. The associations persisted after taking into consideration other variables that could also affect cognitive performance." Another study found that seniors with low levels of Vitamin D were at greater risk of developing Depression. (Natural Products Insider.com)
Another study conducted at Memorial Sloan Kettering found a correlation between higher rates of Vitamin D at the time of diagnosis and survival in colorectal cancer.
In the 1960's when Clinton Ray Miller was in Washington fighting the FDA's attempt to set upper limits on vitamin supplements, Vitamin D was among the products the FDA was trying to set potency limits on.
What Can You Do While Congress is on Break?
Congress will be going home shortly for their annual August break. All members of the House of Representatives and 1/3rd of the United States Senate are running for re-election and will be actively campaigning leading up to the November election.
While Codex Fund.com as a non-profit cannot and does not endorse any candidate and does not actively engage in elections, we are allowed to educate consumers about the issues and to advocate for civic participation.
As citizens, you have the individual liberty to participate and actively inquire of those running office what their positions are on issues that you care about.
Questions you might consider asking?
- Do you support the rights of all Americans to make personal health decisions including the decision to use dietary supplements?
- Do you support the Dietary Supplement Health and Education Act of 1994 (DSHEA)?
- If elected, or re-elected, will you work to make sure consumers continue to have access to dietary supplements and complementary and alternative health practices?
- If elected, or re-elected, will you work to make sure practitioners of complementary and alternative health therapies are not forced out of the health promotion marketplace through onerous legislation or regulations?
- Do you and will you support health freedom?
Please share your stories about attendance at town hall meetings or other activities with legislators with our lobbyist. You can email her at bclay@dc-strategy.com.
August 12, 2010
CODEX and Food Safety Legislation
2010 has proven a very active year for the dietary supplement/health freedom activities in Washington. We had a major victory with Senators Harkin and Hatch, both of whom finally put on the record that the FDA does not have the authority to adopt regulations affecting dietary supplements from CODEX without Congress' instruction. This occurred during the mark up in the Senate of S.510 the Food Safety Bill. The bill technically could come to the Floor in the Senate for a vote at anytime, and Majority Leader Reid noted in mid-July after the Climate Bill and other legislation they were promoting failed to obtain the 60 votes needed to bring it up before the Supreme Court nomination vote; however, this did not occur. We are told by some off the record that the bill has no chance of moving forward in the 111th Congress.
Our primary goal in the legislation was achieved in the mark up. We will use the fall/winter to go back to legislators and work on improved language for the next drafting of the bill as well as to make sure, if the Bill should go forward that nothing deleterious slips in. The thousands of letters delivered to the Senate on CODEX are the reason we got the statements from Senators Hatch and Harkin. Because of those thousands of letters, when our lobbyist, Ms. Beth Clay reached out again to Senators Hatch and Harkin's staff the day before and the day of the hearing, she was able to provide to them once again the specific reasons the Senators needed to make this clarity a part of their opening statements.
Those of you who participated in gathering letters and sending them in, please know that you are the reason we finally have clarity on the Congressional Record from the Senators who are our top bipartisan champions. All of the letters were specifically mentioned in their statements.
FTC
The Federal Trade Commission (FTC), like many Federal agencies under the current Administration, has been pushing to expand their authority. The FTC wants to have broader Administrative Rulemaking Authority than they currently have, as well as broader authorities to levy fines and use their own lawyers rather than the lawyers at the Justice Department to take companies to court. During the legislative process to pass Financial Reform legislation language to accomplish the FTC's expanded authority was included at the last minute in the House version of the Bill. We aggressively fought keeping it out of the Senate's version of the Bill and succeeded. Beth took part in dozens of meetings with Senators and their staff, including most of the members of both Committees of jurisdiction.
During the conference process in which the House and Senate Bills are merged, Congressman Waxman attempted three times to have the language put in the final version. He was rebuffed every time. This was an issue that we and many others in the dietary supplement industry and many other industries fought. Beth participated with the US Chamber of Commerce during this process.
The FTC for two reasons should not have this authority. First they are an 'independent' agency and their rule making does not even have to be cleared by the President's staff before being published. Other non-independent Federal agencies have to clear their proposed rules through the Office of Management and Budget, who work directly for the White House. Second, the FTC is an agency that has authority over every industry in the country and not just one. This is unique. They have in past years proven to over use their authority and in the 1970s Congress clipped their wings through the Moss Magnuson Act. The thousands of letters we delivered mattered a great deal to legislators.
S. 3414
Towards the end of May, Senators Hatch and Harkin introduced S. 3414, the Dietary Supplement Full Implementation and Enforcement Act of 2010. Senator Bob Corker of Tennessee is a cosponsor as well. While we are supportive of the concepts of this Bill, there is work that needs to be done to make the Bill something we can consider endorsing. We are currently working with staff from both Senators Harkin and Hatch's offices to improve the language. It is according to all sources unlikely this Bill will move forward in the 111th Congress; it was introduced as a 'placeholder' to lay the ground work in the 112th Congress for a bill everyone can endorse to be introduced and passed.
Going Forward
Through the Fall, leading up to the election, we will be monitoring both the House and the Senate to make sure no deleterious language affecting the industry sneaks its way into any Bills slated for passage. If predictions are correct and the Republicans take control of the House and or the Senate, the Lame Duck session of Congress from November until the end of 2010 will be a potentially dangerous time for the industry and the nation. If democrats are slated to lose control either the House or the Senate (or both) it is likely they will attempt to pass as many of their Bills of the House, they may attempt to shove through every possible bill they can. Republicans are already considering what bills or sections of bills they want to see repealed. The Lame Duck session will be a time of great monitoring and continued education.
2009 End of Year Celebration
Sunshine Health Freedom Foundation Donors and Participants
A Victory Achieved Because of Your Support and Participation with
CODEXFUND.COM
November 19, 2009: This week all of our hard work paid off. Senators Tom Harkin and Orrin Hatch took an official and public stand that CODEX would not undermine the Dietary Supplement Health and Education Act (DSHEA). Persistence, team work, and taking a stand for what is right have paid off for us. After months of delivering letters, educating legislators and staff in meetings, making phone calls, sending emails and at times being a bit of a pest, our lobbyist Beth Clay was able to get Senators Harkin and Hatch to include in their opening statements for the Senate Health, Education, Labor and Pensions Committee mark up of the food safety bill S510 a declaration that Congress would continue to determine the laws that regulate dietary supplements in the United States and that CODEX would not undermine DSHEA.
Ms. Clay is quick not to take all of the credit however. She worked in collaboration with lobbyists with other key organizations like the National Products Association and the National Health Federation to raise attention to the risk that the language in the original Food Safety bill (S510) regarding CODEX posed to DSHEA and the importance of acknowledging this in the hearing. "It really made a difference that so many people from so many states sent in letters when asked. Having the website, www.codexfund.com, as a resource focused solely on this issue, and kept focused on the facts rather than the hysteria so many internet sites resort to helped our cause significantly." Ms. Clay stated. Senator Harkin, who serves as Chairman of the Committee was clear in his declaration that Congress, was not asking the FDA to look at adopting CODEX guidelines affecting supplements.
Senator Orrin Hatch addressing Chairman Tom Harkin In his written comments which he was unable to deliver personally but submitted to the record, "Mr. Chairman, I too have recently heard from some of my constituents that they are concerned that standards adopted by the United Nation's Codex Alimentarius Commission will restrict their ability to purchase dietary supplement products in this country, so I echo your statements and look forward to working with you and the other sponsors of the bill to make it absolutely clear that access to dietary supplements is governed by laws established by Congress, including DSHEA, and not by Codex standards."
You can go rest easy today that unlike some of the stories you have heard from other sources, your vitamins are not going to be banned by the FDA on December 31, 2009. Tomorrow, however, wake up knowing that we must remain vigilant. Ms. Clay continues to work with Senate staff on the language in the Food Safety bill and warns that Congressman Waxman as Chairman of the House Energy and Commerce Committee is positioned to launch an attack on DSHEA in 2010. We are going to have to keep working hard to make sure that none of the CODEX suggestions on setting maximum upper limits on vitamins and mineral supplements creeps into US regulations. Please visit the website (www.codexfund.com) regularly to be kept informed.
None of this would have happened if it had not been for the following people:
The Sunshine Health Freedom Board:
President - Joan Vandergriff Vice-President - Jim Jenks
Treasurer - Jackie Pinkham Secretary - Kirk Bashaw
The SHFF CODEX Fund Committee: Roger Price and Jackie Pinkham
NSP Managers who have been our biggest advocates faxing in hundreds of letters some on a weekly basis. Every letter mattered. Every donation large and small mattered and continues to matter.
Chris Ritchason and Jack Ritchason, ND, PhD for donating the codexfund.com website and the services of their amazing webmaster.
Dick and Joy Williams - As NSP National's President for energizing all of us and sending out timely information to keep the Nationals informed.
The NSP Executive Team especially Denise Bird, Craig Daily, Greg Halliday, Doug Faggioli, and the Hughes Family for encouraging NSP distributors to participate in SHFF and making time available at our conferences to share information.
And the biggest thank you to our Legendary Health Freedom Activist Clinton Ray Miller who serves as senior advisor to Beth Clay and has throughout the last year provided daily words of wisdom and inspiration and historical perspective on why protecting US dietary supplements against all enemies foreign and domestic.
"We have won a major victory this week and should celebrate. I know from more than a half century of advocating that the battle for health freedom will continue. I look forward to continuing our efforts into 2010. As long as God keeps me on this earth, I will be fighting the good fight of liberty and preserving access to dietary supplements." Clinton stated.
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