Regulatory Focus™ > News Articles > Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

Posted 29 January 2015 | By Alexander Gaffney, RAC 

Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements.

The bill, known as the Safe Food Act of 2015, is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole job would be to regulate food.

Read the text of the bill here.

At present, FDA regulates many food products—those labeled with nutritional information, primarily—while other food products like meat, fish and poultry are regulated by 15 other agencies, including the US Department of Agriculture.

Section 101 of the SFA calls for FDA to transfer most of the functions of its Center for Food Safety and Applied Nutrition (CFSAN) to the new Food Safety Administration, as well as "the resources and facilities of the Office of Regulatory Affairs" at FDA which cover food regulation. FDA's Office of the Commissioner would also transfer resources and authority over food regulation to FSA.

Parts of FDA's Center for Veterinary Medicine (CVM) would also be transferred to the FSA, the bill states.

What Happens to Dietary Supplements?

The removal of oversight over food products would still leave FDA with authority over the regulation of pharmaceuticals, medical devices and tobacco products, but would likely leave it unable to regulate one crucial type of product: dietary supplements.

Under current US law (the Dietary Supplement Health and Education Act, or DSHEA), dietary supplements are technically food products—not pharmaceuticals.

Per FDA:

A dietary supplement is a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, of the following substances:

  • a vitamin
  • a mineral
  • an herb or other botanical
  • an amino acid
  • a dietary substance for use by people to supplement the diet by increasing the total dietary intake
  • a concentrate, metabolite, constituent, or extract

Crucially, DSHEA states that, with few exceptions, "a dietary supplement shall be deemed to be a food within the meaning of this Act."

While the Safe Food Act doesn't explicitly mention dietary supplements, it uses similar language to the Food Safety Modernization Act (FSMA) of 2011, which covers the regulation of dietary supplements.

SFA's definition of term "food" is as follows:

"(A) IN GENERAL.—The term ‘‘food’’ means a product intended to be used for food or drink for a human or an animal.

(B) INCLUSIONS.—The term ‘‘food’’ includes any product (including a meat food product, as defined in section 1(j) of the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable for use as human and animal food that is made in whole or in part from any animal, including cattle, sheep, swine, goat, or poultry (as defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)), and animal feed."

As dietary supplements are "intended for ingestion" under DSHEA, that would seem to imply that the new FSA would have authority over them as well.

Whether that's an inadvertent oversight on the part of the bill's sponsor or not remains to be seen, however. For a bill that could potentially change how a multibillion-dollar industry is regulated, the bill is shy on details about what authority over supplements FSA would—and wouldn't—have.

And there is, of course, the matter of FDA's name—the Food and Drug Administration might need to seek out a new name, a new acronym or both should the bill pass.


Categories: Regulatory News

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