FDA Commissioner Scott Gottlieb, M.D., said earlier this month that the agency plans to strengthen its oversight of the industry but did not provide concrete details. The growth of the supplement industry has led to an increasing number of bad actors entering the market with dangerous supplements or making false and misleading claims for their products, he said.
Gottlieb is aiming to change that by increasing government scrutiny of the fast-growing industry and exploring whether Congress needs to amend the Dietary Supplement Health and Education Act of 1994 (DSHEA), which governs the industry.
FDA will hold a meeting in the spring to discuss ways to update the DSHEA. But so far details are scant, and industry groups are concerned the devil may be in the details. And at least some supplement makers say the law does not need to be modernized. Instead, they say, FDA needs to make better use of its existing powers.
“There’s not a whole lot of meat on the bones at this point,” Daniel Fabricant, president and chief executive officer of the the Natural Products Association (NPA), a trade association representing the dietary supplement industry, told Bloomberg Law. Fabricant was formerly with FDA in the Division of Dietary Supplements (now the Office of Dietary Supplement Programs at the Center for Food Safety and Nutrition), which oversees supplements.
Industry Growth
The supplement industry is big business. It’s worth $40 billion in the U.S. and the global market is poised to reach $278 billion by 2024, according to a report by Grand View Research, Inc. Major dietary supplement companies include Bayer Corp.'s One A Day brand, Pfizer Inc.'s Centrum brand, and Otsuka Holdings’ NatureMade brand.
The dietary supplement industry is much more loosely regulated than the prescription drug industry. The DSHEA has not had a significant update in the 25 years since it became law, even though the industry has seen tremendous growth. Three out of every four Americans now take a supplement regularly.
And, unlike pharmaceuticals, dietary supplements are not subject to premarket approval or the kind of safety and effectiveness testing required for drugs. Instead, they are regulated as food. FDA is only empowered to recall unsafe supplements after they hit the market.
“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Gottlieb said in the statement announcing the enforcement push.
“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” Gottlieb said. “To continue to fulfill our public health obligations, we need to modernize and strengthen our overall approach to these products.”
Use Current FDA Powers?
But Fabricant is not so sure. “We encourage the FDA to use the current tools it has at its disposal to protect consumers from companies selling illegal products masquerading as nutritional supplements,” he said. “Current authorities aren’t being used; why aren’t we out there using the existing powers?”
“I look at the agency’s enforcement tools as adequate and able to respond to current day problems,” he said. “The agency has so much data at their fingertips,” he said. “Are they using it, or are they just waiting on their heels?”
Stopping entry of illegal supplements is one example, Fabricant said, noting FDA can stop shipments at ports. The agency already has the power to issue import alerts and import bulletins. And the agency can use its powers to seize illegal products and enjoin rogue companies, he said.
While the agency’s roadmap itself is far from clear, overall FDA’s announcement is a net positive. “The supplement industry needs consumer trust, and by rooting out ‘bad actors’ with effective enforcement, those companies with quality ingredients and products can rise above existing consumer confusion or misleading information,” Kevin Bell, an intellectual property litigator with Porzio, Bromberg & Newman in Washington, D.C., said.
FDA already has the power to go after and remove adulterated products with illegal ingredients from the market, Gretchen DuBeau, executive and legal director of the Alliance for Natural Health USA (ANH-USA), a nonprofit working on behalf of the natural health community, told Bloomberg Law. FDA can and should take action against bad actors who manipulate the public’s trust in supplements to market products spiked with illegal ingredients, she said.
“FDA has had these powers for decades,” Bell agreed. Historically, the problem for the agency has been a lack of enforcement resources.
More Details Please
But without more specifics, industry groups are grappling with what the modernization efforts may mean for their members.
“Commissioner Gottlieb’s statement lacked many details needed to fully analyze its possible impact on consumer access to dietary supplements,” DeBeau said. “We look forward to hearing more from the agency on these proposals, but we’re proceeding with caution.”
“Supplements compete with drugs, and drug companies are the main client of the FDA. We believe this conflict of interest explains the FDA’s often misguided approach towards the supplement industry, and we’re concerned that the new policies outlined in Commissioner Gottlieb’s statement will continue in this vein,” she said.
ANH-USA is concerned FDA’s approach may seek to impose preapproval requirements on supplements that entered the market post-DSHEA. Instead, ANH-USA wants FDA to update its policies to allow supplement companies to communicate truthful claims about the benefits of supplements to consumers.
And the Center for Science in the Public Interest, a consumer safety and science advocacy group, says modernizing the law is long overdue.
“It’s encouraging that Commissioner Gottlieb seems open to making changes to the Dietary Supplement Health and Education Act—the deeply flawed law that has long handcuffed FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today,” Dr. Peter G. Lurie, the center’s president, said in a statement. Lurie is a former associate commissioner at FDA.
In the meantime, “everyone is leaning forward on their chairs to hear the rest of the story,” Bell told Bloomberg Law. Bell represents many dietary supplement companies as well as the NPA.
Read more in Gottlieb’s statement and the DSHEA.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.