This month’s Issue will be of interest to those of you who include dietary supplements in your personal healthcare plan. In late March of 2022 the U.S. Food and Drug Administration (FDA) submitted its budget requests for the federal fiscal year 2023 (October 2, 2022 through September 30, 2023). Reviewing what is being funded reveals the policy priorities of the Executive Branch for the upcoming year.

The dietary supplement trade associations have been carefully reviewing this 413 page document for clues as to whether these government priorities might match up to the trade priorities.

From their comments it appears some were hoping for:

• Dietary supplements regulations appropriately differentiated from pharmaceutical drugs
• Dietary supplements recognized as important to the health and wellness of American consumers
• Americans being empowered for self-care by continuing to have access to a broad range of safe, reliable, and affordable dietary supplements
• Advocates for the removal of obstacles to the dissemination of truthful and not misleading information on benefits of dietary supplements to consumers
• A reasonable pathway to market certain ingredients in both the pharmaceutical and dietary supplement markets

However, most of these hopes were dashed. It is interesting to note that the industry trade associations’ remarks on the proposed 2023 budget reveal there is not a united front on a number of the budget items. But some of this may be due to differing ways of defining and/or interpreting policies. You are encouraged to read for yourself the pages of the budget dealing with dietary supplements (selected below).

Issue: Are you happy with next year’s FDA dietary supplement budget priorities?

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 with the actual FDA 2023 proposed budget document (noting pages mentioning dietary supplements), plus articles reflecting the conflicting positions among industry trade associations and their cautions about some items. Read carefully.

Fiscal Year 2023 Food and Drug Administration Justification of Estimates for Appropriations Committees
Department of Health and Human Services

Proposed budget for $8.4 billion to support FDA’s public health agenda including: Public health and consumer protection; Modernization to keep pace with evolving science and technology; and Emergency preparedness and response.

Pages 17-18: New funding would also support the hiring of staff to develop new compliance policies and coordinate industry compliance and increased enforcement activities related to food allergens, update IT systems to increase regulatory oversight over cosmetics and increase scientific and regulatory capacity for dietary supplements.

Page 54: Modernizing the Dietary Supplement Health and Education Act (DSHEA)
“…FDA is seeking to amend DSHEA to: (1) require annual listing with FDA of individual dietary supplement products, including basic information about each unique product; and (2) clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products. These amendments would allow FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.”

Page 92: Significant data gaps exist to monitor the thousands of chemicals that are contained in foods, dietary supplements, and cosmetics.

Industry Reacts to FDA FY 2023 Budget Request; Proposal to Modernize Dietary Supplement Regulation (3/29/22)
WholeFoods

Biden’s Budget Proposal: Implications for Natural Health (4/5/22)
Alliance for Natural Health

The Nuts and Bolts of FDA’s 2023 Budget Request (4/12/22)
by Mike Montemarano
Nutraceuticals World

Is mandatory product listing for dietary supplements imminent? (9/13/21)
by Jennifer Grebow
Nutritional Outlook

You are encouraged to go to post your comments.