I would hope the trade associations, individual companies and consumers file comments in the 90-day comment period that take strong issue with the FDA positions on what constitutes proof that an ingredient is grandfathered, the criteria under which an existing dietary ingredient becomes an NDI, synthetic production of natural extracted ingredients and the need for manufacturers to notify products containing ingredients that have already been the subject of an NDI. The idea that this is business as usual and the industry will adapt is a bad one, and numbers and political influence are critical to getting this guidance reversed.
If nature-identical synthetic compounds are to be considered novel, then by all rights the proteins expressed by synthetically assembled oligonucleotides in the form of genes that have been artificially inserted into species which would not otherwise or naturally translate or express those genes into proteins, should also be considered novel. However the FDA's position on GMO proteins is that they are "substantially equivalent" to naturally existing proteins. Clearly a major hypocrisy or double standard.
Technical Director, Extracciones Naturales S.A. de C.V.
Is FDA limiting the marketplace? I think FDA wants to have 100% safety, and this has always been a challenge for our industry. We ought to move the grandfather date from 1994 to 2007 because that’s when AERs went into effect and we have three years of AER data.
If it were me and I was FDA and was really interested in cleaning up the markeplace, I would have set a medium wall I could reasonably enforce given the funding I’m going to get. It would separate companies that do the right thing from companies selling anabolic steroids, which clearly are new. If I were FDA I would have allowed a reasonable acceptance, with the balance of safety and acess, and identify rogue guys that are ignoring the law, and direct eenvorcement against them. Instead they build this bill about 100% safety, and a lot of decent companies will not be able to jump over. At the end of the day you want to drive out the bottom feeders of the industry that are making things that should not be in the marketplace.
President and CEO
Council for Responsible Nutrition
Why isn't there an economic impact report attached to this guidance document? It appears that almost all dietary supplements on retail store shelves will have to submit an NDI or a waiver for an NDI. Does [the FDA] have any idea how much that would cost industry? Does [the FDA] have any estimation of what it would cost to have toxicity tests performed for a single dietary supplement? It appears many supplements simply do not generate sufficient revenues to justify investment in such testing?
Under the guidance document as written, the FDA presumes all dietary supplements produced after 1994 to be impure and toxic until proven otherwise. Yet there have been no widespread reports of toxicity or birth defects. So is this just a paperwork exercise? Will dietary supplements be safer by complying with this guidance document? Since dietary supplements have been shown to be safer than aspirin, table salt, tap water and even food, what does [the FDA] expect to find by this expensive exercise? What public health problem does the draft guidance actually fix?
Resveratrol Partners, LLC