The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database.
On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and Pensions (“HELP”) Committee passed the Food and Drug Administration Safety and Landmark Advancements Act (“FDASLA”). The HELP Committee Chairwoman, Patty Murray (D-WA), said, “Following so many alarming reports in the past of known carcinogens in products like baby powder, hairspray, and kids make-up, and so many years of dietary supplement manufacturers making unsupported health claims without any serious FDA oversight, I’m glad we were able to work in this legislation to ensure FDA can at long last provide meaningful oversight over cosmetics and dietary supplements.”
The FDASLA would hand over more regulatory authority to the FDA. It would require supplement manufacturers to list all of the ingredients (even those contained in proprietary formulas, blends, colors, and flavors) contained in their finished products with the FDA. The information would be made available to the public on the FDA’s searchable database.
Several Trade Associations have expressed criticism of the FDASLA as it would leak manufacturers’ proprietary information to the public, add more regulatory costs and burdens to the dietary supplement industry, and possibly lead to pre-market approval for dietary supplements akin to medical devices and pharmaceutical drugs.
“Unfortunately, the current draft of this bill does not include this essential protection, nor does it safeguard confidential business information,” the Council for Responsible Nutrition ‘s (CRN) President Steve Mister stated. “In addition, this bill includes new language that would grant FDA broad authority to potentially prevent legitimate dietary supplements from entering the market at the whim of the agency.”
Many manufacturers are reluctant to divulge all the “11 herbs and spices” in their proprietary blends and flavor profiles. When the Therapeutics Goods Administration (Australia) required product listing for dietary supplements, it only required the active ingredients to be listed. This was a good compromise between industry and the administration. Perhaps the US Legislature should consider a similar approach to Australia and allow manufacturers to protect their proprietary information.
Dietary supplements have been regulated by the FDA since 1994 with the passage of the Dietary Supplement Health and Education Act (DSHEA). The FDA already has the authority to enforce structure/function and other related health claims and remove those bad actors from the market. This proposed legislation would only place a greater burden on dietary supplement manufacturers and ultimately increase consumer costs.
The American Herbal Products Association (AHPA) stressed its opposition to mandatory product listing because it is “unnecessary and redundant” to existing FDA authority. The AHPA adds the Act is unlikely to address any clear regulatory need and will reduce access to safe and lawful dietary supplements.
As this is a political issue at this time, it is uncertain if logic will prevail. FDA already has a voluntary product listing for dietary supplements, which houses various labels. However, this proposed legislation would require mandatory product listing that goes far beyond the label. We will watch this issue and report accordingly.
If your company has questions about mandatory product registration, our team can help you take the steps necessary to come into compliance. Contact our team today for assistance.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
