In the most recent installment of FDA’s Division of Drug Information (DDI) Webinar Series, speakers from the agency stressed dietary supplements are regulated and products tainted with drugs are not dietary supplements.
In the webinar sponsored by FDA’s DDI, Center for Drug Evaluation and Research (CDER) and Office of Communications, Capt. Jason Humbert, R.N., national health fraud coordinator in FDA’s Office of Regulatory Affairs, said “tainted supplements" is not the correct term for products adulterated with active pharmaceutical ingredients (APIs).
“These are not considered dietary supplements, but drugs pretending to be dietary supplements," he said, noting the practice of selling tainted products “defies logic."
Humbert noted such intentional adulteration has become way more sophisticated since the “Golden Age of American Quackery" (1865 to 1906), during which drugs were sold like any other product and often contained dangerous, misidentified and addictive ingredients (e.g. alcohol, cocaine, heroin, opium) without restrictions, had no label disclosures or warning of misuse, and manufacturer information was not listed.
Today, tainted products come in all shapes and sizes, he advised, noting such products are sold in retail stores, gyms, fitness centers, convenient stores, bridal and resort magazines and hair nail salons. Many such products originate from overseas, which often means labels that are confusing and non-compliant with U.S. regulations.
Humbert warned many of these labels do not list all ingredients, feature drug-like usage recommendations and boast being made in the USA and/or compliant with GMPs (good manufacturing practices). “But they are not," he countered.
“The agency does not issue gold stars," Humbert assured, referring to GMP compliance. However, he debunked the common misconception in the healthcare community that supplements are not regulated. “FDA regulates both finished dietary supplements and dietary ingredients," he confirmed.
In reviewing the history of dietary supplement GMP regulations, Humbert noted FDA inspectors typically do not find adulteration during GMP inspections. “Many of the offenders are not registered with the agency, like responsible companies are," he explained.
Instead, the agency usually learns of tainted products from consumer complaints or when there is an issue reported to the agency. “Until we examine these products, we have no idea if they present a problem," he said, noting if FDA finds it difficult to spot tainted products, imagine how consumers feel—the list of adulterants found in various product categories can range from bodybuilding compounds (e.g. anabolic steroids, analogues, aromatase inhibitors), prescription drugs, corticosteroids and banned/illicit drugs.
The webinar also featured Nicole Kornspan, M.Ph., consumer safety officer at FDA, who reviewed some of FDA’s efforts and findings in the area of tainted health products. Immediately after learning of and confirming a tainted product is on the market, the agency adds product and marketing info to its publicly available list of tainted products, which currently contains more than 800 products and covers more than 40 adulterants.
Kornspan said weight-loss has been a top area of adulteration, alongwith bodybuilding and sexual enhancement—there’s been a recent uptick in tainted women’s sex products. However, adulteration crosses many health targets, including arthritis, diabetes, chronic pain, hypertension, high cholesterol and hypothyroidism.
After identifying a tainted product, FDA will also issue a public notification with as much info as possible on the product including the undeclared APIs, a packaging or labeling photo, and link to recall, if applicable.
She pointed out while tainted products often masquerade as supplements, FDA also has found such products marketed as foods and cosmetics. The agency has found coffee and tea tainted with weight-loss drugs, identified through inspections at international facilities. And it has uncovered tainted skin lighteners, antiaging creams and bentonite clay masks with the help of departments of health in several states, including Minnesota.
In the case of tainted cosmetics, Kornspan noted complaints or adverse events are not just for individuals using the creams, but also for children in the house, due to the products’ transference properties.
Challenges to FDA Efforts to Protect Public from Tainted Products
Humbert and Kornspan noted FDA faces two primary challenges in keeping tainted products off the market: lack of cooperation during investigations and bad actors intent on using modern technology to keep their deceptive operations one step ahead of regulators.
In the sports nutrition segment, many bodybuilding ingredients have confusing or made up names, Kornspan explained, noting the bad actors are using lab tricks. “As soon as a gradient gets added to the controlled substance list, they create a new variation, so we're always … needing to play catch-up."
Humbert reported FDA investigators have found companies are not forthcoming and even purposefully mislead them. “Often, there are so many layers of finding out who is ultimately responsible for the products," he said. There is a low barrier of entry to the market, he added, and these companies use the internet to operate more stealthily.
One common method these companies use is to find an overseas supplier of APIs and have the drug ingredients shipped via international mail. He said some such ingredients and products do come through regular commercial import shipping channels, but most are being smuggled in through the mail, often addressed to family, friends and neighbors.
Federal authorities have developed more rapid screening tools and can sometimes identify suspected tainted product shipments that list suppliers and product names with known histories of adulteration, but it is difficult for FDA to keep up.
Humbert noted even after a tainted product is identified, the supplier or marketer will change the name and keep selling. “It is a cat and mouse game trying to trace these products," he lamented.
When they do catch up with a company peddling tainted products, a class 1 recall is almost always issued, Humbert noted. These are voluntary recalls requested by FDA, which then oversees the companies recall strategy and implementation. “We hardly ever, if never, receive or are notified by a firm selling tainted products that ‘I just realize my products are tainted and I need to recall those;’ this is the agency approaching the firm to conduct a voluntary recall."
If the company does not accept FDA’s request to recall the products, the agency can take further action such as issuing warning letters, conducting product seizures and/or taking the company to court.
Humbert said these cases involve criminal offenses, and FDA’s Office of Criminal Investigations (OCI) is busy with such cases involving illegal imports and misbranded drugs.
“There is no single approach of this problem," he countered. “Enforcement is one method, but there is also outreach and education."
Kornspan explained with the flood of tainted products hitting the U.S. market, FDA considers consumer outreach important part of its efforts to protect the public. “These may have dangerous ingredients and we do not have the resources to investigate everyone."
Both speakers stressed the importance of awareness and reporting tainted products and associated health problems.
“We only hear about [these products] when there’s a problem," Humbert said, adding such notices most often come from FDA’s MedWatch system, consumer complaints, some healthcare provider reports and, rarely, private labs that tested the products as a course of business.
In addition to MedWatch, the public can report tainted products by emailing email@example.com or via its OCI website, which can be done anonymously. For more information on FDA’s efforts against tainted products, visit its Health Fraud website.