In a briefing with media today, Joshua Sharfstein, MD, principal deputy commissioner of the U.S. Food and Drug Administration (FDA), outlined the steps his agency is taking to stop the manufacture, distribution and sale of illegal drug products masquerading as dietary supplements—particularly in the body building, weight loss and sexual enhancement categories.
These steps include the publication of a stern letter from FDA Commissioner Margaret Hamburg to the dietary supplement industry outlining its legal obligation to prevent tainted supplements from reaching the market; the creation of an RSS Feed to more rapidly notify consumers and retailers of known tainted supplements; and a mechanism for industry and others to anonymously alert FDA about potentially tainted products.
“Today FDA is calling attention to an important public health problem: serious injuries caused by products masquerading as dietary supplements,” Sharfstein said. “FDA has received numerous reports of serious adverse events and injuries associated with the consumer use of these tainted products, including stroke, acute liver injury, kidney failure, pulmonary embolism and death.”
The problem of tainted supplements is not new, of course, but it does seem to be getting worse—at least in several areas. Since December 2007, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements, Sharfstein said. Most of these products are marketed in three categories: weight loss, sexual enhancement and body building.
“This is progress, but we cannot claim success,” Sharfstein said. “Far too many suspect products continue to be advertised online and elsewhere. That is why today, to protect the public, FDA is stepping up our efforts.”
Representatives from the major U.S. dietary supplement trade associations—the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA), the United Natural Products Alliance (UNPA), the Consumer Healthcare Products Association (CHPA) and the Natural Products Association (NPA)—joined Sharfstein on the call. Each lauded the FDA for its efforts to eradicate tainted supplements and protect consumer access to legitimate dietary supplement products.
“We join the FDA and our colleagues in the dietary supplement industry to drive these pirates out of our industry and to protect public health and safety and the millions of consumers of dietary supplements who do rely on these products for daily health needs,” said UNPA Executive Director Loren Israelsen. “We have been astonished at the unfortunate growth of this particular class of products, which are intentionally spiked.”
In her letter to the dietary supplement industry, Hamburg outlined the scope of the tainted supplement problem and the legal responsibility of manufacturers to prevent tainted products from reaching the U.S. market.
“Manufacturers, distributors, importers and others in the supply chain of dietary supplements are responsible for ensuring that their products comply with the statutes and regulations FDA enforces,” Hamburg wrote. “Therefore, responsible individuals should take appropriate steps to ensure that their products do not contain active ingredients that may cause the product to be an unapproved new drug, a misbranded drug and/or an adulterated or misbranded dietary supplement.”
For companies that manufacture, import, distribute or sell dietary supplements “that may be vulnerable to potential adulteration,” Hamburg said FDA recommends those companies “investigate their full supply chain and review their manufacturing and quality assurance activities to ensure the lawfulness, quality and safety of their products.” Products in the body building, sexual enhancement and weight loss categories “should receive extra attention and scrutiny from manufacturers and distributors,” Hamburg added.
Companies and individuals who are involved in the manufacture or sale of tainted supplements could be criminally prosecuted. “The government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act (the Act) and endanger the public health,” Hamburg said. “Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted.”
In describing Hamburg’s letter to reporters, AHPA’s general counsel, Tony Young, said: “FDA’s letter is strong and firm. It is the strongest letter I have seen in 35 years of law practice.”
Added Sharfstein: "The letter is very clear that the conduct we are talking about is illegal and that there will be criminal penalties when appropriate. That is a very clear message we want to convey."
Each of the dietary supplement trade associations on the call said they would widely distribute Hamburg’s letter to their members.
“Today’s announcement puts the companies who market illegal products on notice that FDA will flex the full force of its regulatory muscle to punish criminals engaged in illegal activity,” CRN President and CEO Steve Mister said. “We fully support increased enforcement for those who put the health of consumers at risk by selling illegal spiked products and that put the health of the legitimate dietary supplement industry at risk by injuring our reputation.”
Along with its RSS Feed system for more quickly alerting consumers and retailers to tainted supplements on the market, the FDA also talked about its mechanism for industry to report suspected tainted ingredients or finished products to the agency. The FDA’s Criminal Investigations website enables individuals to report—even anonymously—suspected criminal activity.
As UNPA’s Israelsen noted, the people and companies involved in the business of tainted supplement often “work in the shadows” and can be “very difficult to find.” That’s why it’s particularly important that legitimate companies help identify and turn in those who are responsible for tainted products.
“Our manufacturer, distributor and retailer members can play a role here to help FDA address these supplement hijackers,” AHPA’s Young said. “More eyes and ears on a problem like this always help.”
CRN’s Mister agreed. “Although our companies are not part of this problem, we want to be part of the solution,” he said. “So we will be urging all manufacturers to increase their vigilance in their supply chains and manufacturing processes, to use the new FDA tools talked about today to report contaminated ingredient shipments or tainted products that they identify in the marketplace.”