Higher costs and regulatory hurdles could keep promising supplements out of reach—and leave consumers paying more for fewer options. Action Alert!
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THE TOPLINE
- FDA’s new guidance could mean fewer supplement choices and higher prices by making it more expensive for companies to bring ingredients to market.
- Documentation and testing expectations could discourage innovation, including products based on traditionally used herbs, higher-dose formulations, and improvements to existing ingredients.
- ANH urges FDA to preserve a workable path to market by giving appropriate weight to historical use and existing research, and tying additional testing to specific safety concerns.
Imagine a small supplement company developing a new herbal product. The plant has been used for generations, and the company has research supporting its safety. But bringing it to market could require detailed records of decades-old use or additional testing the business cannot afford.
The company shelves the product. You never get the chance to try it.
That is the kind of outcome ANH fears from FDA’s newly finalized guidance on new dietary ingredients. The document describes the safety information FDA expects companies to provide for certain supplement ingredients. It can get somewhat technical, but our main concern is access: if bringing products to market becomes too expensive, fewer choices will reach store shelves and consumers will lose out.
How Paperwork Can Become a Barrier
For new dietary ingredients (NDIs, or supplements that are considered “new”, i.e. they came to market after 1994), companies must notify FDA at least 75 days before marketing and provide evidence supporting the product’s expected safety.
ANH has long warned that FDA could turn this notification process into something resembling a pre-market approval system—one in which the expense of satisfying the agency becomes a barrier to selling supplements. That appears to be exactly what is happening and guess where the template for more red tape is coming from? You’ve guessed it: the EU and its draconian Novel Food Regulation.
FDA’s broader draft guidance on NDIs threatens supplement access on two fronts: it makes NDI compliance more costly while expanding the range of ingredients subject to those requirements. Even changes to how an existing ingredient is manufactured could trigger the need for an extensive safety submission—creating expensive hurdles for improvements to familiar products.
This guidance lays out what FDA expects supplement companies to show about certain new ingredients before selling them—including what the ingredient is, how it is made, and why the proposed amount is expected to be safe, either from historical use evidence or other evidence of safety, which the agency says can include genetic toxicity testing, 90-day animal studies, and, in some circumstances, clinical human studies. It all sounds like a good thing. But imagine how many so-called ‘old’ ingredients might get caught in the ‘NDI trap’ simply because they use a more modern processing method that, for example, increases the bioavailability of a nutrient?
As we’ve said for ages now: expecting a swathe of clinical studies from drug companies for drug licensing is one thing, since drugs are typically patented and approved drugs are granted a period of exclusivity, meaning the costs of producing the studies for FDA approval can be recouped. Supplements, being natural, cannot generally be patented as strongly, nor can they be sold at prices that are comparable to drugs, so it can become cost prohibitive to put together these safety studies.
Generations of Use, but Not Enough Records
When companies rely on historical use alone, FDA now says at least 25 years of widespread use is needed. Just like the EU. It also expects details about that use and how it compares with the proposed supplement.
Consider an herb traditionally prepared as a tea. People may have consumed it for generations without keeping precise records of how much they drank, how often, or at what ages. A company may therefore have considerable evidence of traditional use but still lack the documentation FDA wants. Filling those gaps could require expensive research.
Traditional use does not automatically establish that every dose is safe. But the FDA is setting up a situation in which potentially useful ingredients could be priced out of the market because modern research records are not available for supplements or herbs used for decades.
Higher-Dose Options Could Become Harder to Offer
The guidance also raises concerns about higher-dose products.
When companies use animal studies to support safety, FDA recommends calculations that reduce the amount considered acceptable for people to account for uncertainties.
For a product going through this process, those calculations could leave the company with evidence supporting a lower serving than it intended to offer. It might then need to fund additional studies or reduce the dose.
The concern is that the cost of supporting a higher dose could discourage companies from offering it, narrowing options for consumers and practitioners.
Improvements Could Come with a Bigger Price Tag
Imagine a company developing an ingredient that the body absorbs more easily, potentially allowing consumers to take fewer capsules.
For a product subject to notification, research on the original ingredient may not fully support the improved version. The company may need additional evidence explaining how the change affects safety. You can bet the FDA will consider even the most basic manufacturing changes enough to trigger the need for more studies.
You can see the game being played here. In the name of “safety,” the FDA erects all these obstacles for supplement innovation and market entry. As we’ve said for years, the FDA isn’t protecting us: supplements are, and have been for decades, overwhelmingly safe. The FDA is really protecting drug industry profits by making it harder and harder for supplements to compete.
Consumers Pay the Price
A product does not have to be banned to become unavailable. Sometimes, the company simply cannot afford to launch it.
Businesses with large research budgets may be better positioned to absorb the costs. Smaller companies may abandon products, and those that proceed may pass additional expenses on to customers.
Consumers deserve safe supplements and meaningful choice. FDA should give appropriate weight to credible historical use and existing research, and tie additional testing requests to specific safety questions.
Protecting consumers should include preserving a workable path for responsible companies to bring supplements to market.
Action Alert!
