By Mark Blumenthal and Jana Hildreth Mark Blumenthal is the Founder & Executive Director of the American Botanical Council and Editor of HerbalGram Jana Hildreth is CEO and Technical Director of Blaze Science Industries LLC
Many consumers who cannot afford or tolerate certain prescription drugs turn to herbals and dietary supplements to address their health needs. While there are many legitimate dietary supplement products on the market, some of these products are inappropriately and fraudulently marketed as “all natural” alternatives to leading prescription drugs.
These products claim to treat a variety of conditions including erectile dysfunction, or claim to enhance weight loss, bodybuilding and athletic performance. Many experts and responsible members of the herb and dietary supplement industry have known for years that these fraudulent products derived their “amazing effects” from undisclosed levels of prescription pharmaceutical drugs. However, until recently, they were powerless to take action due to the lack of adequate enforcement by government agencies, like the Food and Drug Administration (FDA).
These products are intentionally adulterated or “tainted” with active pharmaceutical ingredients, or APIs, as commonly referred to in the legitimate sectors of the dietary supplement industry. For example, drugs like sibutramine (the ingredient sold as Meridia®) have been found in products sold for weight loss; sildenafil (Viagra®) and related compounds for erectile dysfunction have been found in male enhancement products; and bodybuilding and performance-enhancement products have been spiked with illegal steroids.
Most of these products have been formulated and manufactured by people who do not have the appropriate chemistry, medical or pharmaceutical training in facilities that lack any reasonable level of quality control. For years these products slipped under the FDA radar since they were primarily sold in convenience and adult video stores, as well as through magazines and the Internet.
The good news now is that the federal government has begun to take a strong stand against these fraudulent products and claims. The FDA has been sending warning letters to companies selling these products, and in over 200 cases, the FDA has forced the companies to recall their illegal products.
On December 15, 2010, FDA Commissioner Margaret Hamburg sent a letter to the dietary supplement trade associations announcing the FDA’s new crackdown on the sale of APIs masquerading as dietary supplements, and asking for industry support in communicating the FDA’s new program to all members of the industry. On the very same day, the FDA, in association with representatives of the 5 leading dietary supplement industry trade associations, held a press conference announcing the FDA’s new program to inform consumers, health professionals, and the dietary supplement industry about these products and the problems which their sales and usage represent. For the press release, click here.
Unfortunately, the companies who are selling the illegal API-containing products are seldom, if ever, members of any of the leading trade groups. One the one hand, you have ethical, responsible companies doing as much as is possible to help ensure that their dietary supplement products are made with properly identified and qualified ingredients; are produced according to appropriate good manufacturing practices (GMPs, which are now required by the FDA for all supplement manufacturers); and are marketed with appropriate claims for their potential benefits.
On the other hand, lamentably, are those manufacturers and marketers who are not legitimate, and who do not interface with the responsible elements of the dietary supplement industry.
As noted by the FDA, because consumers of these fraudulent products do not realize that they are taking a prescription drug(s), they may be subject to various serious health complications, including drug interactions and/or serious adverse side effects, including “strokes, acute liver injury, kidney failure, pulmonary embolisms (artery blockage in the lung), and death.”
It will take some time to remove the majority of the “bad players” and fraudulent products from the marketplace. In the meantime, consumers should use common sense when choosing a supplement and make sure to talk to their doctors and pharmacists when adding them to their dietary and health regimens.