The FDA’s New Dietary Ingredient (NDI) notification process threatens consumer access to thousands of dietary supplements. The biggest issues in the original guidance remain in the latest revised version, and it is critical that the document be revised again to reflect what was intended in DSHEA: to expand, not restrict, consumer access to supplements, and not to turn supplements over to drug companies.
The 2011 draft guidance threatened to cripple — if not eliminate — the supplement industry. An economic analysis at the time from an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant: the elimination of tens of thousands of supplements from the market; an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and the loss of between 55,270 and 104,475 jobs in the supplement industry.
FDA Wants to Regulate New Dietary Ingredients like Drugs
The guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, not of supplements. In addition the agency states that additional safety studies would be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification.
Are other drugs–even dangerous antipsychotics, antidepressants, and stimulants–subject to population-specific safety studies when they are used on children? The answer is a resounding No. In the FDA’s own words, “Most drugs prescribed for children have not been tested in children.” The same is true for use with elderly people. The drugs have almost never been tested on elderly people. This makes the FDA’s new position on supplements especially hypocritical.
The section on investigational new drugs (INDs) also remains. These provisions could destroy the future availability of many supplements. The jargon used here in the guidance is confusing, probably intentionally so, but bear with us.
Remember that an IND refers to a new drug, while an NDI refers to a new supplement. Under current law, if an IND application is filed for an ingredient-that is, an ingredient is being studied for use as part of a new drug-that ingredient can no longer be produced or included in a supplement if an NDI has not previously been accepted. This has already happened to pyridoxamine, a form of vitamin B6, even though in the end it resulted in this valuable form of natural B6 being no longer available either as supplement or drug.
The FDA explicitly states that even when an IND is rescinded or does not lead to a new drug, the supplement form is still banned. Under this new FDA Guidance, a drug company can corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever more, if they so choose.
The FDA is also broadening the group of substances that must submit NDIs by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting a NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed. This to me seems intentional: the FDA is trying to destroy the supplement industry by making innovation impossible.
Don’t let the FDA Do It!
The FDA has also kept intact its ridiculous position that synthetic botanical ingredients are, for the most part, not dietary ingredients. This would likely remove many products from store shelves, such as vinpocetine, which is needed to keep our brains healthy. There is an exception for synthetic botanicals that are lawfully used as an ingredient in the conventional food supply, such as vanillin. What makes this even more confusing is that the FDA has already accepted NDI notifications for vinpocetine from a number of supplement producers.
Probiotics–the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on–could also be on the chopping block. The agency cites risks for these supplements which are purely theoretical and have never posed a problem. Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product. Having probiotics subject to prescription or costing $100 a bottle will be a disaster for the health of Americans.
Moreover, this guidance is just one more of an unending series of attacks on supplements by the FDA that are clearly intended to benefit the drug industry. By now, it should be clear that the FDA cannot provide credible oversight, or unbiased regulation, of the supplement industry. Another regulator is needed.
The NDI guidance needs to be amended to protect my supplement access and to reflect what Congress intended in DSHEA. Click here to send a message to the FDA and your State Representatives:
Let them know that you want them to STOP trying to take away your access to safe and effective nutritional and herbal supplements because the FDA and Big Pharma want to remove these supplements from the competition or to make them drugs.
We cannot stress how critical it is for everyone who has not yet submitted a comment to the FDA on this issue to do so now. The guidance will threaten too many vital supplements and effectively kill innovation in the supplement industry. We must stop the FDA from moving forward with its new regulations disguised as a “guidance” document.
Highest-Level Action Alert! If you haven’t already, send a message to the FDA, please send your message immediately! Here is what I just sent. You can write your own, or you can just send a duplicate of the same thing by clicking here: