Is the clock ticking on Natural Supplements?
This article is not intended to spread fear, but rather to keep you informed about what could potentially be a crippling blow to the natural supplement industry.
Over the past few months, we have learned (and are continuing to monitor) that the FDA could be preparing to unleash an anti-supplement act targeted towards the natural supplement industry as early as next year (2022). This new policy has the potential to eliminate tens of thousands of natural products from the market—in the middle of a pandemic.
Recently, the FDA announced by the end of June 2022, it plans to draft a number of policies, among them 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 natural supplements we’ve seen in decades.
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” (NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. With the implementation of this proposed new policy, however, the FDA has turned a simple notification procedure into ade facto pre-approval process akin to that which is required of pharmaceutical drugs.
The FDA’s policy is nothing less than a massive directive aimed at crippling the supplement industry.
Next year we may see:
- tens of thousands of natural products disappearing from store shelves
- an industry-wide cost of between $2 billion and $165 billion in animal and human safety studies to comply with the FDA’s NDI notification protocols
- the loss of between 50-100,000 jobs in the supplement industry
How will the FDA’s new guidance do this? First, it will impose 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 are required with an NDI notification. The agency states additional safety studies may 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 children, the FDA would require another NDI notification. Not even drugs are held to this standard: the FDA simply states“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 thus are not typically patentable, so if they are also required to conduct pre-market studies, they won’t have the same ability as a drug manufacturer 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.
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 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 ignore the fact that new and more effective ways of producing supplements have arisen in the last 22 years since DSHEA was passed.
If the FDA sticks to its timeline of June 2022, the release of the final guidance could seriously hinder our ability to stay healthy, naturally, during this pandemic.
As indicated at the beginning of this article, this is not intended to spread fear, but rather to provide education on what the natural health industry is potentially looking to surmount in the near future.