A growing number of so called “dietary products” contain compounds which exist only in FDA-approved prescription drugs or closely-related drugs (analogs). In some cases the ingredient is a novel synthetic steroid, which cannot be called a dietary ingredient, the FDA (Food and Drug Administration) announced today. The FDA has sent a letter to manufacturers of dietary supplements expressing concern about this growing tendency.
Nearly 300 products have been flagged by the FDA in public alerts over the last few years, all of them marketed as dietary supplements which were linked to complaints of injury.
Manufacturers and distributors of dietary supplements are bound by the country’s laws, and are responsible for making sure their products comply with the requirements of American law, the FDA’s letter stresses.
Five trade associations have agreed to share the letter extensively within the industry; they include:
- Council for Responsible Nutrition
- Natural Products Association
- United Natural Products Alliance
- Consumer Healthcare Products Association
- American Herbal Products Association
FDA Commissioner Margaret A. Hamburg, M.D., said:
“These tainted products can cause serious adverse effects, including strokes, organ failure, and death. The manufacturers selling these tainted products are operating outside the law.”
Hamburg says the FDA is inviting input and collaboration from dietary supplement trade associations so that makers and distributors can be made aware and educated about this problem.
The most common illegal products are:
- Weight loss supplements – some may contain sibutramine, an active ingredient found in Merida. Merida has been taken off the market because of stroke and heart attack risk. Sibutramine or analogs have been found in numerous products, such as Slim-30, Solo Slim and Slimming Beauty.
- Body building supplements – many contain either anabolic steroids or steroid analogs, which can significantly raise the risk of liver injury, heart attack, stroke, and even death. Some say they contain either anabolic steroids or aromatase inhibitors, such as Tren Xtreme, ArimaDex and Clomed. Aromatase inhibitors prevent anabolic steroids from turning into estrogen.
- Products to enhance male erectile function – such as Vigor-25, Duro Extend, Magic Power Coffee. Many of these products have the same active ingredients as Levitra, Cialis and Viagra, which are prescription medications. Some individuals, especially those with cardiovascular diseases should avoid such compounds.
Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said:
“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids. 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 FDA warns that companies that manufacture, sell or distribute such tainted produce run the risk of:
- receiving warning letters
- enforcement action
- having their products seized
- injunctions
- criminal prosecution
A legal dietary supplement is simply an addition to a standard diet, and may contain vitamins, minerals or some other dietary ingredient. They are regulated under the Dietary Supplement Health and Education Act, which was passed by Congress in 1994.
Drugs have to be approved by the FDA before they are allowed onto the market; dietary supplements don’t.
In a communiqué, the FDA wrote:
“Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.”
Source: FDA
Written by Christian Nordqvist