I thought I'd post this here as it may be of interest for consumers of nutritional supplements. (or drugs for that matter) This is from the June 12th issue of Smart Life News, the newsletter published by the Cognitive Enhancement Research Institute. Frankly I thought the .8mg/800mcg dose of folic acid was considered okay for pregnant women, but maybe the official view is that we're all supposed to take 400mcg regardless...
The FDA's new policy is a renewed attack on the First Amendment and a reaffirmation of their resistance to the Pearson decision. Rather than abandon their prior-restraint approach (i.e., mandatory FDA preapproval of all health claims), the FDA is softening their significant-scientific-agreement standard (which was never defined in the first place) into a preponderance-of-evidence standard (which is also undefined).The definition of regulatory standards is statutorily required by the Administrative Procedures Act (APA), which forbids "arbitrary and capricious" actions on the part of any admistrative agency. This is why the U.S. Court of Appeals for the District of Columbia 1) invalidated the FDA's decision to prohibit four specific health claims submitted by Durk Pearson and Sandy Shaw, and 2) ordered the FDA to define their significant scientific-agreement standard. But rather than work within the APA, the FDA has created a new undefined standard.
Why is the FDA doing this? It's simple. They are completely and unequivocally committed to arbitrary and capricious actions. Some instances? How many readers remember that the FDA arbitrarily applied food-additive regulations to dietary supplements? That led to the Dietary Supplement Health & Education Act of 1994. This year, the FDA is claiming that dietary supplements added to foods are food additives requiring separate FDA approval.
How deep does the FDA's reliance on arbitrary and capricious actions go? The answer is: all the way to the core of the drug approval process. You see, the very "standards" by which the FDA approves or rejects drugs have never been defined! The "highest standards of safety and efficacy in the world" are not written down anywhere. They make it up as they go. As Dr. Robert Temple of the FDA said, "We know efficacy when we see it." Indeed, the FDA's commitment to arbitrary and capricious action is fundamental.The FDA's preponderance-of-evidence standard is not just undefined, it is arbitrary. In the October 6, 2000 Federal Register, the FDA wrote, "the court said that FDA could prohibit a health claim where the evidence in support of the claim is outweighed by evidence against the claim, either quantitatively or qualitatively" [65(195): 59855-7, online at http://vm.cfsan.fda.gov/~lrd/fr001006.html]. Note the use of the word qualitatively. What this means is that the FDA is still determined to hold on to the arbitrary power to emphasize or deemphasize whatever evidence they wish so that they can justify their political agenda - the continuing denial of Pearson's health claim that "0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form." This claim is truthful, not misleading in any significant way, and the FDA still denied it. Arbitrary and capricious to the max!
Fortunately, the U.S. Federal District Court was not deceived by the substitution of the preponderance-of-evidence standard for the significant-scientific-agreement standard that the U.S. Circuit Court had already found to be unconstitutional. In February, Judge Gladys Kessler cited the FDA for continuing violations of Pearson's free-speech rights.
Judge Kessler wrote, "The [U.S. Circuit Court] implied, though it did not state explicitly, that when 'credible evidence' supports a claim, such as the Folic Acid Claim, that claim may not be absolutely prohibited". (emphasis added). This forceful restatement of the Circuit Court's decision is a second shot across the FDA's bow.
"It is not so much that you use your mind wrongly--you usually don't use it at all. It uses you. This is the disease." -Eckhart Tolle, The Power of Now
