…by now changing the rules of the original Dietary Supplement Health and Education Act of 1994. This was designed to allow Americans more access to health freedom and supplements in doses that previously had been very small. Prior to that vitamin C was only available in doses of 60 mg or less, eg. Under the guise of providing the patient public with a “greater level of safety”, the whole thing stinks of drug industry collusion with the government agency it essentially owns in order to impair competition and perhaps allow a drug company to patent a supplement. Care to guess if this will possibly increase the price? To wit…
One key goal of this guidance is to improve the rate of compliance with the NDI notification requirement. In 2012, FDA estimated that the number of dietary supplements on the market was 55,600 and that 5,560 new dietary supplement products come on the market each year.5 This is in contrast to the approximately 4,000 products that were on the market in 1994, when DSHEA was enacted.6 As of December 2014, we had received and completed our evaluation of just over 750 NDI notifications since the first notification was received in 1995.7 These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles.8 To improve public understanding of the NDI notification requirement, this guidance includes an in-depth discussion of the scope of the requirement, along with detailed examples of situations in which a notification would or would not be required.
The entire draft can be seen here. Of course, one might expect that there has been a rash of dietary supplement incidents — death, disability, adverse reaction reports, etc. But compared to the drug industry that the FDA is chartered to regulate — 120,000 deaths per year from adverse drug events when they are PROPERLY prescribed (an underestimate) — the serious and reportable events associated with dietary supplements are almost non-existent.
But how does this work? If a supplement was available prior to 1994, then it is “grandfathered”, as it were. But any new substance, extraction of a substance (more purified version of curcumin, eg), or a combination of substances (a traditional Chinese medical formula that has been used for centuries, eg) might be subjected to this NDI or “New Dietary Substance” scrutiny. This would make this new regulatory vetting so expensive that many (and I mean MANY) smaller supplement manufacturers would be unable to comply. Enter a drug company like Lilly. I have personal knowledge of this company’s strategic interest in taking a big piece of the market for supplements someday. So they might work with our government to rig the game. The real joke on the public is that this government agency cannot properly regulate drugs. They should start there before they take a few $M under the table so the consumer can no longer have access to inexpensive supplements. The game is on. Write your congressperson (unless they have already been bought — which is probable).