The FDA has been controlling the market of natural supplementation and vitamins, suppressing free speech by not allowing suppliers and manufacturers to state the potential health benefits of a product on its label. A federal case brought against the FDA by Alliance for Natural Health-USA (ANH-USA) and other plaintiffs have made some powerful headway against the agency on this gag order and the emerging science behind healthy foods and dietary supplements.
The case was centered on the mineral selenium, in 2009 the agency denied several claims about the effectiveness of selenium and vitamins C and E in reducing cancer risks. In September of 2009, the ANH-USA, dietary supplement formulators Durk Pearson and Sandy Shaw and the Coalition to End FDA and FTC Censorship, represented by Jonathon Emord and the Emord law firm, filed three separate lawsuits against the FDA. The lawsuits sought to reverse the denial of qualified health claims for these supplements, and bring the FDA back into compliance with the law.
The case revolved around “qualified health claims”, where the producer of a food or supplement tries to share the science behind possible benefits of a product with the public. If the science is less than completely conclusive, usually the case with food or food related items, the claim is referred to as “qualified”.
Of course, the FDA doesn't want to support these claims as it will create incentives for consumers to purchase vitamins or minerals instead of going to see a doctor and stepping into the pharmaceutical trap. The agency wants beneficial foods and supplements to be treated like drugs, forcing manufacturers of the product to submit to the full FDA approval process in order to make any health claims. The approval process is of course out of reach for these companies as food and supplements, being natural, cannot usually be patented; subsequently, no manufacturers can afford the billion dollar approval processes. This is the agencies ticket to suppressing the market of the alternative health world, guaranteeing a competition-less environment for the pharmaceutical companies that pay the FDA's bills.
This past June, Judge Ellen Huvelle US District Court of the District of Columbia ruled in favor of ANH-USA in the case against the FDA and the judge rendered a summary judgment showing the case was clear from the start.
ANH-USA sums up the judgement-
“The FDA was indeed violating freedom of speech by saying that no cancer-related health claims about the selenium could be made unless the science was completely conclusive or unless ridiculous and misleading disclaimers were added to the message.”
“Under pressure of our court victory, the FDA is for the first time allowing reasonable “qualified health claims” for some supplements.”
The settlement agreement with the FDA concluded that selenium supplements can state on their packaging “selenium may reduce the risk” of prostate, colon, bladder, or thyroid cancer.”, it must also include the following “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers”. These disclaimer statements are the shortest and clearest ever approved. The last sentence of this disclaimer holds the FDA to expressing only their opinion and is not scientific fact, “based on its ‘review'”, which reinforces to the public the agencies long-time stance against natural medicine.
This is the largest number of dietary supplement/cancer-risk-reduction claims ever approved by the FDA and though this case was focused on selenium, this settlement with the agency is a win at a time when they are poised to gain an exorbitant amount of unconstitutional control (http://www.healthfreedoms.org/2010/12/04/unconstitutional-s-510-food-bill-driven-by-big-food-lobby-dollars/).
What the judge has ruled in the case can and should be applied to any food or dietary supplement producers for they all have a right under the free speech doctrine to talk about the benefits of a product when they can accurately present the science of the claims. Now, without jumping through impossible approval processes, manufacturers and companies can use the boundless amounts of research done on natural foods and medicines to display their potential benefits.
What a great win by these agencies and Emord law for the citizens of the United States.
Illustration by Larry West