FDA Launches New Tools for Reporting Adulterated Supplements

In a proactive move to address tainted dietary supplements in the U.S. market, FDA today announced it has introduced new tools to both publicize and gather reports of adulterated products.

These tools include a new RSS feed on its website to alert consumers about warning letters and recalls for these products, as well as a new e-mail address that consumers, including members of the supplements industry, can use to report products suspected of adulteration-anonymously, if preferred.

FDA made the announcement in a letter issued to the dietary supplements industry today.

In a press conference today announcing the letter’s issuance, FDA principal deputy commissioner Joshua Sharfstein, MD, reported that since December 2007, the agency has issued consumer alerts about nearly 300 tainted products.

“Far too many suspect products continue to be advertised online and elsewhere, and that’s why today to protect the public, FDA is stepping up our effort,” said Sharfstein.

The letter warns industry against manufacturing and selling any tainted products, reiterating that such products and responsible parties may receive warning letters and/or face enforcement actions including product seizures, injunctions, and criminal prosecution.

It also reminded supplement manufacturers to be in compliance with the Current Good Manufacturing Practices for dietary supplements outlined in 21 CFR Parts 111 and 110, including qualifying raw-material suppliers.

Hot Spots

The three product categories in which adulterated products are most often found are weight-loss, body-building, and sexual-enhancement products.

The agency said FDA laboratory tests have revealed an alarming variety of undeclared active ingredients in products marketed as dietary supplements, including anticoagulants (e.g., warfarin), anticonvulsants (e.g., phenytoin), HMG-CoA reductase inhibitors (e.g., lovastatin), phosphodiesterase type 5 inhibhitors (e.g., sildenafil), nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., indomethacin), and beta blockers (e.g., propranolol).

It said it also identified products marketed as dietary supplements that contain active pharmaceutical ingredients removed from the market for safety reasons (e.g., fenfluramine), as well as new chemical ingredients of unknown safety. Also, some products marketed as dietary supplements have been found to contain controlled substances (e.g., benzodiazepines and anabolic steroids).

“Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails,” noted Michael Levy, director of the Division of New Drugs and Labeling Compliance at FDA’s Center for Drug Evaluation and Research.

Working with Industry

Five major trade associations were also invited by FDA to participate in the press conference: Council for Responsible Nutrition (CRN), Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association, and American Herbal Products Association.

The associations voiced their support of FDA’s efforts to crack down on bad actors.

“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, and we fully support increased enforcement for those who put the health of consumers at risk by selling illegal, spiked products, and who put the health of the legitimate dietary supplements industry at risk by injuring our reputation,” stated CRN president and CEO Steve Mister. “So we applaud the agency’s resolve to get tough with criminals, and we will support these efforts in any way we can.”

“FDA’s letter is strong and firm-it is the strongest letter I’ve seen in 35 years of law practice,” said Anthony Young, general counsel for the American Herbal Products Association.

Industry members also stressed the need to distinguish good actors from bad actors.

“We appreciate the agency’s willingness to distinguish between responsible manufacturers and common criminals….There are legitimate supplements in these three categories highlighted today,” said Mister.

“Spiking of supplements with drugs is a crime,” said John F. Gay, executive director and CEO of the Natural Products Association. “We are pleased to support the FDA as it steps up its enforcement efforts to get these criminals off the streets.”

FDA and the associations indicated their intention to collaborate in advancing enforcement. “FDA is working with the dietary supplement industry’s trade associations in this effort,” said Sharfstein. “These organizations know that the dangerous products out there are undermining consumer confidence in legitimately marketed supplements.”

“The very fact that there is a letter and the fact that all these organizations joined together with FDA to hold this press conference gives an indication to the perpetrators out there that everybody is watching this and that they don’t just have to look out for FDA getting ahold of their product, but that the trade associations and their members pledge to help in this effort,” Andrew Shao, CRN’s senior vice president, scientific affairs, told Nutritional Outlook. “So I think it sends the message out there to any companies that are paying attention to this that are intentionally spiking products that more people are watching and you have a potentially greater chance of getting caught.”

He adds, “If you think about how this could have gone down, FDA could have done all of this on their own-issued a letter and held a press conference-but the fact that they didn’t do that and involved the responsible industry says something. I think that by doing this in a joint effort, hopefully it sends the message to the media that these are fringe companies that are doing these kinds of things and that the media shouldn’t paint the industry with a broad paintbrush.”