Durk Pearson & Sandy Shaw’s®
Life Extension NewsTM
Volume 15 No.
2 • March-April 2012
IS THE FDA TRYING TO KILL THE GRANDFATHERS? ARE THEY AIMING AT YOUR FAVORITE GRANDFATHER RIGHT NOW?
FDA Expands Into New Territory Where NOBODY Has Standing To Challenge Them Before a Court
If an agency announces in the Federal Register that it is considering adopting some regulation, which then allows for public comment, this is called “notice and comment” and is how regulations are supposed to be introduced under the Administrative Procedures Act. Anybody can comment for the record and anyone who comments automatically has “standing” to sue the agency before a federal court in an objection to issues brought up by themselves or anybody else in public comments that they deem not to have been adequately dealt with by the agency.
Now the FDA has cleverly broadened the scope of some earlier regulations by simply adding lots of stuff that was never in the regulation originally filed in the Federal Register as a proposed new regulation and allowing for a “notice and comment” period. Nobody can comment on these new regulations that are simply tacked onto existing regulations without an announcement in the Federal Register and, hence, without public “notice and comment;” therefore, nobody has the automatic standing and, folks, it is very hard to get standing where courts are overloaded or don’t really want to hear your complaint.
We are thinking here, specifically, of new rules — cleverly called a “policy guidance” — tightening restrictions on what constitutes an “old dietary ingredient” (that is, one that was on the market — grandfathered — as of the passage in 1994 of the Dietary Supplement Health and Education Act (DSHEA). We call it the FDA’s War on Grandfathers. An example of a rule change is found in this description from a trade publication: “A key issue is determining whether an ingredient is in fact an NDI [new drug ingredient, a non-grandfathered dietary supplement that is not FDA approved] or whether it is an old dietary ingredient (ODI) that has been ‘chemically altered.’ Chemical alteration of a botanical does not include physical alterations such as drying or pulverizing but does include, according to FDA’s new draft guidance, the use of any extraction solvent other than water and/or ethanol.” This is a usurpation, without any legal basis, of the statutory limitations set by Congress in the DSHEA that is the law without any new Congressional legislation or, if in the form of a regulation, any public notice and comment. What about extractions with supercritical carbon dioxide among many other long-used and safe methods? Presumably they are no longer allowed for dietary supplements. Another gift to the pharmaceutical industry.
One Grandfather That Has Already Been Declared Not to Be a Dietary Supplement — You’ll Need a Prescription to Get It
An example of a dietary supplement that has already been removed by the FDA from the grandfathered list was one listed by the Natural Nutritional Foods Association (downloaded in 1995) as being in use before October 15, 1994 (the date when DSHEA took effect); this was pyridoxamine, a lipid soluble form of vitamin B6, that has been found to have potent protective effects against the formation of AGEs (advanced glycation end products), which have been identified as causative factors in aging, diabetes, cardiovascular, and other diseases. A couple of years ago, the FDA suddenly banned pyridoxamine from being sold as a dietary supplement (without any basis in terms of health and safety); a pharmaceutical company has subsequently filed for approval of pyridoxamine to be sold as a prescription drug at an immensely higher price. If pyridoxamine had still been available for use in dietary supplements, we would have included it in our anti-AGEs formulation AGEless,™ but we did include vitamin B6 which has some anti-glycation effects, though not as potent as those of pyridoxamine.
But there’s more — and worse. The FDA “Guidance” says that any new combination of old grandfathered ingredients constitutes a “new dietary ingredient.” There is no basis in either law or existing regulations for that innovation-killing usurpation, either.
- Mark Blumenthal, Dear reader. HerbalGram 91 (2011).