Dietary Supplement Manufacturer Continues to Put Tennessee Consumers in Harm’s Way
Last month, we reported that certain manufacturers of over 70 dietary supplements had committed health fraud against consumers by slipping undeclared, active pharmaceutical ingredients into defective products in Tennessee marketed as “dietary supplements.” A listing of the tainted supplements along with the chemicals and associated health risks are still available at the FDA’s website.
If you’re wondering how these dietary supplements have entered the market without detection of unapproved pharmaceuticals and steroids, here’s a brief synopsis. After intense lobbying by the manufacturers of dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under the DSHEA, the FDA regulates dietary supplements as foods—not as drugs. Consequently, dietary supplements, like food, do not require pre-approval by the FDA prior to entering the market.
Yet again, the regulatory gap created by DSHEA has exposed consumers to unapproved substances with risk of personal injury. On May 11, the U.S. District Court for the Eastern District of Michigan entered a consent decree condemning for destruction about $1.3 million worth of dietary supplements because the products do not contain the adequate information necessary to assure consumers that the supplements are not harmful.
The products are distributed by LG Sciences LLC, of Brighton, Michigan and were marketed for use by body builders. They were distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.” The products contain unapproved steroids that inhibit the activity of the enzyme aromatase. It is not yet known what adverse health effects are associated with the steroids found in these dietary supplements.
Obviously, the de-regulation of the food-supplement industry has proven a disaster—both for the FDA and for consumers across the United States. Widespread public concern, in fact, has resulted in the FDA issuing a final rule, effective 2010, that will change the way food supplement manufacturers do business in the United States.
Until then, we should continue to hold negligent dietary supplement manufacturers and their distributors accountable when personal injuries result. If you have experienced adverse health consequences and believe that they may have been caused by the ingestion of dietary supplements, please contact the knowledgeable and experienced food and drug Knoxville products liability attorneys at Baker Associates today.
