At the 2021 Dietary Supplements Regulatory Summit hosted by the Natural Products Association, Cara Welch, Ph.D., the current acting director of the US Food and Drug Administration Office of Dietary Supplement Programs introduced one frightening piece of new potential authority - a supplement registry.
What Is The Proposed Product Registry and What Does It Do?
This supplement registry is going to be a mandatory listing of all products a company sells that falls under the category of supplement. The FDA wants to know what the market looks like at any given moment and use the database to help remove unsafe or illegal products.
This registry would keep a listing of all dietary products and supplements, the manufacturer, sourcing information, and consumer information, including formulation, serving size, and duration of use.
But, not everyone is pleased with the idea of the new registry. Representatives from the United Natural Products Alliance and the American Herbal Products Association had serious concerns.
Many of their concerns surround enforcement issues and how it will impact smaller herbalists and compounding pharmacists. For example, if the registry requires all supplements to be registered, does that mean the compounding pharmacist or herbalist has to register each and every unique combination with this registry?
To them, it seems like the FDA is looking to put individual herbalists and small companies out of business.
Some Support The Benefits
Many of the supporters have money and large companies behind them.
Scott Melville, president and CEO of the Consumer Healthcare Products Association, said, “To our members on the drug side, it’s not a big deal, and it does provide FDA with that searchable database. Hopefully, this might put pressure on retailers to say, ‘We’re not buying from people not in that database.’ I think it’s sort of an obvious, easy step for this industry to really enhance its credibility and for the FDA, another tool to go after the bad guys.”
Others See The Registry As An Enforcement Tool and Way To Block New Ingredients
Some of the points made by Welch concern smaller organizations.
Welch stated that although this is not an enforcement tool, it can be used to track violations and provide a framework for investigating companies for fraudulent claims. One suggestion for the registry was to automatically create violations based on a predetermined set of criteria.
The registry might place unreasonable restrictions on smaller businesses. It may also put some of these smaller herbal and natural supplements companies out of business completely because of the prohibitive costs of being involved.
Additionally, the FDA being able to monitor the registry at all is a concern. Currently, the FDA only monitors 5% of all supplements on the market, choosing to focus on larger companies and known violations. This registry would focus the FDA’s attention on smaller companies and require a significantly larger employment staff to keep track.
With a larger operating budget, the registry would increase the cost of submitting a product to the registry for approval, closing down the herbal supplement field to a handful of large corporations.
Finally, it would put many compounding pharmacists and herbalists out of business. In a time where small business is hanging on by a thread, anything that places more obstacles in the way of healers and the small businesses should be avoided.
The way the registry was described, an herbalist who recommends something as simple as chamomile tea for relaxation might be forced to submit proof of efficacy to the registry for that particular batch of flowers is truly effective.
Of course, we might not have a choice whether this registry goes through or not. If it does, it could set the herbal and supplemental industry in the United States back 30 to 50 years. As the US is already ten years behind the rest of the world in this field, it could completely knock out a whole generation of herbal lists, natural practitioners, and naturopath.
Under the guise of protecting the consumer under the greater good, you could be denied your favorite supplement or end up paying an exorbitant amount for it.