FDA Commissioner Margaret Hamburg, MD, sent a letter to supplement manufacturers today reminding them of their legal obligations and need to remain vigilant to protect their industry.
Noting it had sent warning letters to more than 300 companies manufacturing contaminated products in recent years, the FDA in this direction established a service that will allow industry to anonymously report instances of questionable supply chain management and product manufacturing.
The “Report Suspected Criminal Activity”service can be found here.
"These tainted products can cause serious adverse effects, including strokes, organ failure, and death," Hamburg wrote. "The manufacturers selling these tainted products are operating outside the law."
Weight loss products, body building products and sexual enhancement products were singled out as being the worst offenders.
All the major trade groups – the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, the Consumer Healthcare Products Association and American Herbal Products Association – backed the measures that they had worked closely with the FDA to develop.
“This initiative should serve as a strong warning to criminals that the government is serious about enforcing the law – and FDA’s actions today will go a long way toward reminding individuals and companies looking to make money without regard for consumer safety that it means business. Those who purposefully spike products are not legitimate dietary supplement companies, and the supplement industry is actively committed to being a part of this problem’s solution.”
They added: “The industry coalition also endorsed FDA’s actions to use its regulatory muscle to hold accountable those who violate the law and jeopardize the public health, using tough criminal sanctions when appropriate.”
The FDA also sought to warn consumers about the kinds of products that are more likely to be contaminated, and ways to detect them.
"The labeling of these tainted products may claim that they are 'alternatives' to FDA-approved drugs, or 'legal' alternatives to anabolic steroids," said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA's Center for Drug Evaluation and Research. "Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails."
The industry groups added that consumers should be wary of products that advertise limited availability, or being ‘barely legal’.
“Regardless of what laws are in place, criminals will try to find ways to break those laws; consequently, consumers also play an important role in protecting their health and should remember to buy from legitimate companies and sources with strong reputations; and to not purchase products with claims that sound too good to be true or suggest drug-like effects when they are marketed as supplements.”
CRN’s senior vice president of scientific and regulatory affairs, Dr Andrew Shao, said the industry groups were working on voluntary guidelines that would help shore up the supply chain, which the FDA was taking part in also.
The groups took part in a live online discussion with the FDA today, hosted by FDA principal deputy commissioner, Joshua Sharfstein, MD. At that meeting, Anthony Young, legal counsel for AHPA, called the FDA letter the strongest action he had seen from the agency in 35 years in the nutritional products industry.