Those of you who include dietary supplements as part of your wellness program will want to follow the evolution of a newly introduced Congressional bill that would remove some food safety matters from the oversight of the U.S. Food and Drug Administration (FDA).

Currently, dietary supplements are regulated under the FDA and the U.S. Department of Agriculture (USDA).

But on 7/13/22 Senate bill S.4520 Food Safety Administration Act of 2022 (sponsored by Sen. Richard J. Durbin [D-IL]) and the identical House bill H.R.8358 Food Safety Administration Act (sponsored by Rep. Rosa DeLauro [D-CT]) were introduced.

Initially the action of these bills is to divide the FDA into two parts: the Food Safety Administration and the Federal Drug Administration.

Keeping in mind that dietary supplements are legally defined as food, you might assume that it is certain that dietary supplements will be included in all “food” regulatory matters. However, as this bill was being drafted, dietary supplements remained with the drugs to be regulated by the new Federal Drug Administration. Then when the bill was introduced, that was changed so that dietary supplements appear to be grouped with other foods to be regulated by the new Food Safety Administration. We do not, however, find specific mention of this in the texts of the bills.

There are other matters that appear to be missing in the discussion for these two bills. For example, the proposed new regulatory agency, Food Safety Administration, is reported as indicating this as a “single food safety agency.” But the initial bill does not bring over what is currently under the USDA’s Food Safety and Inspection Service or other federal agencies with niche roles in food safety.

Those who view vitamins and drugs as competitors are rooting for separating all food-related regulatory matters, including dietary supplements, from all drug-related regulatory matters. However, it is noted that at this early stage of the bill’s evolution, few dietary supplement industry associations appear secure enough concerning where the Senate and House bills will end up to comment on what they appear to be offering.

It will be interesting to track the refinements of S.4520 and H.R.8358 as first committees, then the full House and Senate debate.

Issue: Whether or not to divide the current U.S. Food and Drug Administration into a Food Safety Administration (including dietary supplements) and a Drug Safety Administration.

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in this month’s issue, below we provide you sources to begin to understand some of the key concerns to track as S.4520 and H.R.8358 evolve.

DeLauro and Durbin introduce The Food Safety Administration Act for a move toward a single federal food safety agency (7/13/22)
by Dan Flynn
Food Safety News

S.4520 – Food Safety Administration Act of 2022 (7/12/22)
Congress.gov

S.4520 [text of bill]
U.S. Senate

Food Safety Administration Act of 202 [fact sheet]
U.S. House of Representatives

AHPA endorses the Food Safety Administration Act (7/19/22)
American Herbal Products Association

New Bill to Remove FDA Control Over Supplements (8/2/22)
Alliance for Natural Health USA

Bills would relieve FDA of supplements oversight (7/21/22)
Natural Products Insider

Lawmakers introduce Food Safety Administration Act (7/19/22)
by Erica Shaffer
Pet Food Processing

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