On June 21, 2018, the federal Office of Management and Budget (OMB) released its recommendationsfor reorganizing many functions of the federal government to improve efficiency, effectiveness and accountability. One recommendation was that food safety regulations would be removed from the responsibilities of the U.S. Food and Drug Administration (FDA) and all food regulations would be transferred to the U.S. Department of Agriculture (USDA).

Currently the FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation (per FDA website). The proposed change would rename the FDA as the Federal Drug Administration and continue its responsibilities for drugs, devices, biologics, tobacco, dietary supplements, and cosmetics. The USDA Food Safety and Inspection Service (FSIS) with its expanded responsibilities would become a single agency housed at the USDA and called the Federal Food Safety Agency.

This proposal to have the food safety functions of the FDA moved to the Department of Agriculture, and making only one agency responsible for ALL food regulations, appears to be a logical move for streamlining administrative processing. However, dietary supplements in the U.S., and in most world trade organizations, are designated as FOOD, not drugs. A concern raised by some is that leaving dietary supplements under the jurisdiction of the new Federal Drug Administration could result in dietary supplements eventually being designated and regulated as drugs. It is unclear if the decision to leave dietary supplements under the FDA jurisdiction was due to a lack of understanding of the industry or was deliberate. If you use dietary supplements, you may be motivated to keep your eye on this matter as the proposed government agency shuffle progresses.

ISSUE: Will dietary supplements be food or drugs – according to federal oversight designation?

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in learning more about this month’s issue, the following related articles were selected to serve as a foundation for learning more about this matter.

The Federal Food Safety Agency: A Proposal to Move FDA Food Safety Responsibilities to the USDA (7/5/18)
by A. Bryan Endres
FarmDocDaily
“In the context of food safety, OMB proposed merging FSIS and the food safety functions of FDA into a new agency housed within USDA called the Federal Food Safety Agency.  The FDA would be renamed the Federal Drug Administration and would continue to regulate drugs, devices, biologics, tobacco, dietary supplements, and cosmetics.”

White House proposes a narrowing of FDA’s mission — and a new name (6/21/18)
by Ike Swetlitz
STAT
“The idea of changing a key mission of the FDA comes amid a turf war between the FDA and the USDA.”

Trump administration proposes changes to HHS, FDA (6/24/18)
by Gergory Twachtman
Oncology Practice
“Food oversight functions would move from the Food and Drug Administration to the USDA;FDA would be rebranded the Federal Drug Administration and focus on drugs, devices,biologics, tobacco, dietary supplements, and cosmetics.”

Trump Administration Proposes Consolidating Federal Food Safety Responsibilities into Single Agency at USDA, Renaming FDA the “Federal Drug Administration” (6/21/18)
Saul Ewing Arnstein & Lehr
“Per the proposal, FDA would continue to regulate dietary supplements. Currently, FDA regulates supplements as foods – a fact that might be lost on some – although it regulates them differently than ‘conventional’ foods.”

We encourage you to post your comments. You are also invited to share additional resources you have found relating to this issue.