Proposals to move FDA's responsibility for food into a separate agency raise the question of where dietary supplements and cosmetics would land.

"FDA's cosmetic and dietary supplement regulatory programs do not fit comfortably in a structure that is divided between medical product and food regulation," according to Michael R. Taylor, a former FDA deputy commissioner for policy turned health policy professor at George Washington University.

Taylor advocates a separate Food Safety Administration, which would leave FDA to focus on medical products, a plan put forward by some lawmakers.

He authored a recent report, "Restructuring Food Safety at HHS: Design and Implementation," which was published as an appendix to a study sponsored by Trust for America's Health and the Robert Wood Johnson Foundation. That study calls for appointing a single FDA official over food safety in the short term and later creating a separate agency (¹ Also see "U.S. Needs FDA Food Safety Czar Now, Separate Agency Later, Group Says" - Pink Sheet, 30 March, 2009., p. 19).

In the event of a split, the ultimate regulatory home for supplements and cosmetics - both now under FDA's food center - is of "great interest to the regulated industries and other stakeholders and thus requires careful consideration," Taylor said in his report.

He said there are "legitimate arguments on both sides of the issue of whether these programs should be in the FSA or the medical products agency," in the event a separate agency is created under the Department of Health and Human Services.

Taylor said while "supplements are categorized legally as food and housed" in the Center for Food Safety and Applied Nutrition, "the supplement category includes not only vitamins, minerals and other clearly nutritional substances but also herbal products and others that are marketed and sought after for their drug-like effects."

He said questions about whether supplement claims cross drug claim lines are a "recurring issue."

Attorneys Say No To Drugs

Ricardo Carvajal, an attorney with Hyman, Phelps & McNamara, said Taylor's comments seem to suggest "that perhaps the dietary supplement program should be housed in the medical products agency," not the food agency.

But supplements are clearly foods, Carvajal said in an April 2 FDA Law Blog post. Provisions of the Food, Drug and Cosmetic Act "definitively settled the question" that dietary supplements should be regulated as food and "nothing about the recent or current food safety crises suggests otherwise," he said.

He added "it strikes us as curious" that unlawful marketing claims for some supplements are cited as a reason for regulating the products as drugs. Such claims are "a problem that needs to be addressed through enforcement," Carvajal said.

Former FDA Chief Counsel Peter Barton Hutt said the agency has always classified supplements as food. "Clearly, supplements are food," he said. "After all, supplements contain the same things that your food contains," said Hutt, who is currently with Covington & Burling. "To put them in the drug category would create chaos ... absolute chaos," he added.

He said regulating supplements as medical products would cause conflicts. "You'd have a vitamin regulated one way by FDA when it's in food fortification or in a so-called functional food" and "a different way by a different group of people with different policies if it were labeled as a dietary supplement."

"You'd have two competing government agencies. There is nothing worse in this world than two competing agencies," Hutt said.

He noted with FDA's current authorities, there is a single commissioner to decide issues. However, "If you have two commissioners that will be battling each other, you are going to have chaos. It's the same substance used for the same purpose."

Daniel Fabricant, VP of scientific and regulatory affairs with the Natural Products Association, predicted that with a separate food agency, supplement regulation would go to the new agency. He said supplements, like food, consist of components found in the diet and should be regulated as food.

"You get nutrients from supplements and you get nutrients from food. And I think that was Congress' intent, with respect to" the Dietary Supplement Health and Education Act, Fabricant said.

Holes In The Argument?

Hutt said Taylor's report does not fully consider that duplication of many resources would be necessary to support a separate food agency, and particularly that two commissioners will be needed.

Establishing a separate food agency would bring "no synergy, just pure duplication," Hutt said, calling Taylor's report "way, way off base."

In an e-mail, Taylor said the report addresses the need for resource duplication in several areas and discusses costs that will be incurred to implement the agency and reorganize.

Hutt said the report does not take into account that "everything" will have to be duplicated, including border inspections. He said a separate agency would dilute FDA funding when instead its appropriation should grow, especially for more staff.

Fabricant emphasized increasing FDA's resources. "I think we've got bigger issues" than revisiting where supplements should be regulated, including updating the food good manufacturing practices, he said.

Hutt said a recommendation by Taylor to place the Center for Veterinary Medicine in a food agency "ignored" the dilemma of CVM having both drug and food divisions.

"Then you would have the same drug regulated by one group for animal use and by another group for human use. And they may come to totally different conclusions when it is the same substance," Hutt said.

"That's why you should keep the whole thing together in something called the Food and Drug Administration," he said, adding FDA is "the strongest brand name in the entire United States" and it would be "a terrible mistake" to "destroy that brand name."

No Easy Answer On Cosmetics

Taylor also raised the question of how cosmetics should be regulated. Currently they are under CFSAN's Office of Cosmetics and Colors. "The scientific and safety issues it raises are more akin to those addressed by the dermatology division of FDA's Center for Drug Evaluation and Research, and one of the recurring issues in cosmetic regulation is whether marketing claims and intended uses for some cosmetic products render them legally drugs," he said.

Whether more closely related to food or drugs, the threat of increased regulation looms if either foods are separated or cosmetics moved into the drug regulatory jurisdiction. The brunt of cosmetics regulation will continue to fall to industry, which seeks to ensure safety through Cosmetic Ingredient Review expert panel meetings.

Self-regulation is vulnerable at a time when product safety is prioritized higher - and innovation perhaps lower - and policymakers receive public advocacy groups more hospitably.

Hutt also said cosmetics "clearly belong on the food side" and still under FDA's regulatory authorities. He added, cosmetics do not have active ingredients and they use many of the same ingredients as food does. "Most cosmetics are basically inert. You don't want drugs in your lipstick, I assume," he added.

Picture Still Developing

William Hubbard, a former associate commissioner at FDA, said the Obama administration likely is considering FDA's current resources, food safety system, mission and statutory authority as part of the agency review.

"It is too early to predict the outcome," Hubbard said. But neither supplement nor cosmetic regulation "is very well resourced, however, so any major change in level of regulation would have to be accompanied by increased funding."

Rep. Rosa DeLauro, D-Conn., chair of the House Appropriations subcommittee with FDA oversight, this year reintroduced the Food Safety Modernization Act, H.R. 875, which would establish a separate food agency.

However, the amount of firm support the bill has from DeLauro's colleagues is still unclear. Several key lawmakers have said the issue must take a backseat to solving more immediate problems with food safety (² Also see "First Course For Waxman: Fix Food Safety, Hold The Separate Agency Plan" - Pink Sheet, 16 March, 2009., p. 16).

While the White House has not taken a formal position on whether a separate food agency is needed, the president promised a complete review of the agency and already appointed an interagency working group to advise him on food safety.

- Katie Stevenson (k.stevenson@elsevier.com) and Ryan Nelson (r.nelson@elsevier.com)

Would Supplements’ Regulatory Home Change With A Separate Food Agency?

More from Archive

More from Pink Sheet