WASHINGTON—States should step up efforts to regulate a $32-billion-a-year dietary supplement market that is subject to lax oversight at the federal level, according to a paper published online Sept. 23 in the Journal of Public Health Management & Practice. As a “reactionary" system that “relies on the presence of injury or fatality before regulatory action can occur," the federal system is inadequate to protect consumers from products that are marketed for weight loss and muscle building, according to the paper.
The authors from Temple University, Harvard University, University of Rhode Island and Boston Children’s Hospital recommended a number of state measures to protect youths from harmful sports supplements. The recommendations for state action included imposing age limits tied to the purchasing of sports supplements, testing products for adulterants such as steroids, requiring warning signs at retail outlets and on packages, and even the possibility of taxation.
“The lax federal regulatory scheme for dietary supplements leaves extreme gaps in federal oversight that should be filled by state governments," concluded the authors, who recommended state attorneys general step up their role regulating supplements. “States should use core public health policy strategies to protect consumers and especially young people from ineffective, mislabeled, and potentially dangerous products marketed for weight control and muscle building."
Attorneys general in California, Connecticut, New York, Ohio, Texas and Vermont—several states that have been active in supplement regulation and litigation—declined comment or didn’t respond to requests for comment on the study, “The Dangerous Mix of Adolescents and Dietary Supplements for Weight Loss and Muscle Building: Legal Strategies for State Action."
Leaders of trade associations representing the dietary supplement industry blasted the paper and its recommendations.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), expressed concern that the recommendations, if carried out, would lead to a patchwork of different state laws that would confuse consumers. Mister said about 30 states have passed laws that are identical to the Federal Food, Drug, and Cosmetic Act (FD&C), granting attorneys general authority to enforce the state laws.
The recommendations described by the authors “would be a nightmare for consumers and manufacturers," said Pieter Cohen, an assistant professor of medicine at Harvard Medical School, who has studied supplement safety and called for tougher regulation of dietary supplements. “There are fundamental flaws in the federal laws regulating supplements and that might lead to this kind of crazy patchwork as states try to address it independently."
Mister said FDA has the tools to protect consumers without the need for increased state regulations, but he questioned whether the agency is using all of them.
“FDA absolutely has all the authority and tools it needs to enforce the law," he said. “We are concerned FDA seems to be reluctant to use some of these civil and criminal tools it has at its disposal to really" go beyond the issuance of warning letters. “We see an awful lot of warning letters for violations of GMPs, introducing adulterated markets in the market, making outrageous claims to treat Ebola and cancer and we’d like to see more of those move to prosecution."
Jennifer Pomeranz, the study’s lead author and assistant professor of public health and a member of Temple’s Center for Obesity Research and Education, indicated the states should step up their roles regulating the dietary supplement industry until at least FDA is given more authority and more forcefully asserts its existing power.
Daniel Fabricant, the former supplement chief at FDA and current CEO of the Natural Products Association (NPA), said the federal system is capable of preventing future harms. For instance, he referenced court-ordered injunctions that have prohibited supplement manufacturers (in breach of federal law and FDA regulations) from operating and making any products that could endanger consumers.
“I will take the experts at the federal level over the experts at the state level every day of the week on dietary supplements and twice on Sundays," Fabricant said.
The paper cited a recent outbreak of hepatitis to illustrate the dangers associated with sports supplements. As of March 2014, the Centers for Disease Control and Prevention (CDC) reported 97 cases and one death in 16 states potentially linked to OxyElite Pro, a supplement marketed for weight loss and muscle gain. Roughly half the cases are in Hawaii, where local officials last year reported one death and the need for two liver transplants.
“Why wouldn’t Hawaii now say, ‘how can we let this happen again?’" asked Cohen, who has argued FDA’s post-market surveillance system to detect dangerous dietary supplements is inadequate.
Fabricant, who was director of FDA’s division of dietary supplement programs at the time of the outbreak, said the agency moved swiftly to remove the product from the market amid a government shutdown. The OxyElite Pro cases were first brought to the attention of the Hawaii Department of Health in September 2013. The manufacturer of OxyElite Pro, USPlabs, ultimately agreed to destroy supplements worth about USD $22 million, and reformulate its product by removing an ingredient after FDA declared it was not proven to be safe.
Noting that supplements do not require premarket approval under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the academic researchers said the onus is placed on FDA to establish a product is unsafe or caused harm before the agency can take regulatory action.
“This reactionary system relies on the presence of injury or fatality before regulatory action can occur," the authors wrote. “The FDA is under resource constraints while facing an expanded set of obligations, making it unfeasible for the agency to test all potentially adulterated, unsafe, or mislabeled products."
A number of sports supplements have been laced with pharmaceutical drugs and linked to adverse health effects such as hypertension, stroke and liver injury, the authors wrote. Adults are not the only ones who are exposed to such harmful substances. The paper cited studies showing use of weight loss and muscle building products by adolescent boys and girls.
From 2008 through 2013, FDA flagged 340 supplements—including bodybuilding, erectile dysfunction and weight loss products—that were "tainted" with concealed drugs and other dangerous chemicals. Sexual enhancement, weight loss and muscle-building products comprise more than 90 percent of the more than 400 products that are listed in FDA's tainted supplements database, Robin Koon, executive vice president of Best Formulations, a contract manufacturer of nutritional supplements, told Natural Products INSIDER earlier this year.
The authors recommended states impose a minimum age to purchase sports supplements, similar to alcohol and tobacco, based on the premise that the products are “inherently risky and not medically indicated." Fabricant indicated such a recommendation, if implemented, is a slippery slope, and he asked whether Gatorade and Coca-Cola would be subject next to age restrictions.
“We’re not talking about cigarettes here," he said. “We’re talking about food products. And we’re talking about a food product with clear directions for use."
A proliferation of muscle-building supplements that contain “synthetic steroidal ingredients" may have spurred on the researchers’ recommendations for state action, said Rick Collins, a lawyer whose regulatory practice caters to the health, fitness and dietary supplements community.
“This market has existed for over 15 years, despite the fact that many of these steroidal ingredients do not fit the requisite criteria to be marketed as dietary supplement products under DSHEA," said Collins of the Mineola, New York-based law firm Collins, McDonald & Gann. “Although nearly a dozen federal prosecutions have targeted the industry, with more in the works, new players have replaced older ones and the FDA’s limited investment of enforcement efforts in this area have been unable to eradicate these products."
A bill passed by the House of Representatives in September would authorize the Drug Enforcement Administration to crack down on so-called anabolic steroids.
The legislation, if passed by the Senate, “will effectively end the industry and stop sales of these products to young and old alike," Collins said.