Recently, the FDA announced that, by the end of June 2022, it plans to release drafts or final versions of a number of policies, and among them is the “new dietary ingredient” (NDI) guidance (“new supplement” guidance, in plain English). It is no exaggeration to say that this is the most dangerous threat to supplements we’ve seen in decades. We must continue to vehemently oppose the guidance as currently written and demand that substantial changes are made before the final version is released. It is especially dangerous given that we are in a pandemic situation that is constantly evolving, with scientists warning of viral variants that evade vaccine-induced immunity.
Here is some brief background. Under the Dietary Health and Supplement Education Act (DSHEA), any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. In implementing this policy, however, the FDA has turned a simple notification procedure into a de facto pre-approval process akin to that which is required of pharmaceutical drugs.
The FDA’s policy is nothing less than a massive broadside aimed at crippling the supplement industry. How do we know this? An economic analysis estimated that the guidance would result in:
- tens of thousands of products disappearing from store shelves;
- 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.
How does the FDA’s guidance do this? First, the guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA’s guidance describes how to determine what kind of safety studies to submit with an NDI notification. The agency states that additional safety studies may be needed if the target population of supplements 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. Not even drugs are held to this standard: the FDA states that “most drugs prescribed for children have not been tested in children.”
Safety studies for supplements may sound reasonable, but just remember: requiring these studies is part of the FDA approval process for drugs. Drugs can afford them because they are patentable. Supplements are natural and are not strongly patentable, so if they are also required to conduct pre-market studies, they don’t have the same ability to recoup those costs. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market. Supplements also have a consistently sterling record of safety.
The FDA is also broadening the group of substances that must submit new supplement notifications 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 an 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.
There are even more problems with the guidance that interested readers can reference in our previous coverage of this topic.