Originally published February 8 2010
CSPI calling for outright censorship of "structure and function" claims for nutritional supplements
by Ethan A. Huff, staff writer
(NaturalNews) The Center for Science in the Public Interest (CSPI) has put together a 158-page report for the Food and Drug Administration (FDA) that contains detailed information about food manufacturers that it says are making false or misleading health claims about their products. The powerful lobbying group is urging a restructuring of the regulatory system that would likely damage the nutritional supplement industry and eliminate freedom of health speech.
On the surface, the CSPI report primarily targets "Big Food" manufacturers like Kellogg's and Nestle which have been making embellished, deceptive health claims about products that are essentially junk foods with miniscule amounts of vitamins and minerals thrown in. But rather than address the need for the FDA to crack down on these illegitimate claims, CSPI is seeking to abolish the freedom to make health claims altogether.
The CSPI tactic is a popular one, identifying a legitimate problem while suggesting an illegitimate solution. While on the surface regulatory "reform" seems to have consumers' best interests in mind, the kind of reform suggested by CSPI would actually eradicate free speech by muzzling all legitimate health claims made for natural products.
DSHEA and the freedom to make health claims
As it stands under the Dietary Supplement Health and Education Act (DSHEA) of 1994, health product manufacturers can legally make legitimate health claims about their products. The Act provides for structure/function claims, which are not reviewed and authorized by the FDA, and qualified health claims, which are typically supported by conclusive scientific evidence.
Both types of claims are regulated by the FDA using an "innocent until proven guilty" approach which allows product manufacturers to include information at their discretion. The FDA can challenge questionable claims if it perceives them to be false but it must provide conclusive evidence before requiring it to be removed. If the FDA is unable to prove that a statement is false, manufacturers are permitted to print the information as long as the mandatory dietary supplement disclaimer is included on the container explaining that the FDA has not evaluated the claims.
Supplement manufacturers legally use both types of claims to educate consumers about the health benefits of their products. However CSPI and other groups seem to believe that such a system should be disbanded. Many organizations mistakenly believe and perpetuate the false idea that dietary supplements are wholly unregulated and that the entire sector is a free-for-all. While there are some bad players, including Kellogg's and Nestle, the majority of companies within the industry are making truthful, valid claims about their products.
Advocates worked very hard to pass DSHEA in 1994, the single most important piece of legislation in protecting freedom of health speech in the U.S. So why the push to eliminate it by the very groups and agencies that claim to support the public interest?
Food control by a few
It is important to understand that the players who stand to lose the most from increased restrictions and regulations are small- to medium-sized nutritional supplement companies, the true pioneers in the natural health world, not the large multi-national corporations operating supplement divisions. Small manufacturers make up the majority of the supplement industry.
In 2007, the FDA initiated its "current Good Manufacturing Practices" (cGMP) guidelines in accordance with DSHEA provisions that tasked the agency with ensuring that dietary supplements are manufactured safely and accurately. As worthy as it sounds, the FDA ended up designing cGMP with large manufacturers in mind, placing an immense new burden on small manufacturers.
The one-size-fits-all requirements for daily operations and record keeping are expensive and laborious, making it virtually impossible for small manufacturers to comply. The rules also mimic pharmaceutical requirements, many of which are pointless and unnecessary for supplements.
Hundreds of supplement manufacturers will likely be put out of business once the three year phase-in of cGMP is complete in June of 2010. The final installment on this date will force companies with fewer than 20 employees, which represent a large portion of the industry, into compliance. This final group is said to be hit the hardest by mandatory compliance.
Many dietary supplement trade groups are on board with the FDA's agenda, including the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN). The CRN membership roll is filled with multi-national giants such as Archer Daniels Midland, Bayer, Cargill, and Dow Chemical Company, as well as pharmaceutical companies like GlaxoSmithKline, Novartis, and Pfizer.
Copying the EU to bring about a world standard
According to Dr. Robert Verkerk, the executive and scientific director of the Alliance for Natural Health, the two primary sources of attack against natural health freedom are European Union (EU) regulations and Codex Alimentarius.
The EU's Nutrition and Health Claims Regulation (NHCR) is arguably the most restrictive health law yet to be passed anywhere in the world. Established in 2006, NHCR allows health claims to be made only if they have been preliminarily approved by the European Food Safety Authority (EFSA). In opposition to the U.S. model where a health claim is supposed to be considered valid unless proven false, the EU now operates under the Napoleonic law structure where a health claim is false and restricted until declared valid by an unelected body of bureaucrats.
Under the NHCR restrictions, no unauthorized health claims can be made in either print or speech. This means that doctors are not allowed to recommend foods or supplements to their patients, nor can they offer any other type of health advice unless it has been rubber-stamped by the EFSA. Even if scientific studies prove that a nutrient or food is effective at treating a certain disease, a doctor is prohibited from speaking about it unless it is formally approved.
The consequences of such a draconion restriction on free speech is the decimation of the natural products industry, including everything from trade shows and educational seminars to naturopathic practices and health food stores. The restrictions on the free flow of health information also has the potential to eliminate over time all knowledge amongst the population about natural health, other than what is approved by the overlords.
Codex Alimentarius, the world food code
All of this ties into Codex Alimentarius, the world food code designed to integrate and harmonize the world's food guidelines for the purpose of power and control. While Codex has not yet been fully implemented worldwide, the pieces are slowly being assembled as to eliminate all national sovereignty and bring all nations into unified, international compliance with its dictates.
In the United States, provisions in the NAFTA and CAFTA treaties helped to facilitate the harmonizing of U.S. law between North and South America, a precursor to late compliance with Codex. Similar to the NHCR in the EU, Codex will operate under the Napoleonic law system, permitting only what has been approved to be lawful.
Codex's Vitamin and Mineral Guidelines are also being designed to dictate which vitamins will be permitted for use and in what doses. According to researchers, vitamin doses will be assessed using toxicity risk assessment, the method used in pharmaceuticals to determine the dose at which a drug becomes identifiably toxic. When applied to vitamins, this method will ensure that permitted doses remain below therapeutic levels, rendering them useless.
The CSPI recommendations are merely a stepping stone toward a much larger goal of global control over food, for which supplements are only a part. If successful, it could become illegal to even buy and sell unadulterated foods and supplements, let alone speak freely about their health benefits.
Sources for this story include: http://www.anhcampaign.org/news/anh-feature-... http://www.newswithviews.com/Richards/byron3... http://www.thenhf.com/press_releases/pr_26_j...
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