Dietary Supplements
Due to inadequate testing or outright deception, consumers have suffered a range of health-related problems as the result of taking any number of over-the-counter weight-loss products and other dietary supplements.
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The FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.
The FDA is responsible for taking action against any unsafe dietary supplemental product after it reaches the market. Generally, manufacturers do not need to register with the FDA or receive FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.
The FDA's post-marketing responsibilities include monitoring safety, e.g., voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
Due to inadequate testing or outright deception, consumers have suffered a range of health-related problems as the result of taking any number of over-the-counter weight-loss products and other dietary supplements containing kava, ephedra and other harmful ingredients.
Companies that knowingly market such defective and dangerous products have been held liable by the courts for creating unsafe products; misrepresenting such products as "all natural" when, in fact, they contain synthetic ingredients; and for being negligent in failing to change certain products despite government warnings that they could cause serious illness - including heart damage, brain damage, strokes and liver damage.
Dietary supplements that have recently have been added to the FDA’s watch list include:
Androstenedione
The Food and Drug Administration sent a letter to companies that manufacture, market and distribute products containing androstenedione, or "andro," which acts like a steroid once it is metabolized by the body, and therefore, can pose similar kinds of health risks as steroids. These products are generally advertised as dietary supplements that enhance athletic performance based on their claimed anabolic and androgenic properties to stimulate muscle growth and increase production of testosterone.
The FDA has sent warning letters to 23 companies asking them to cease distributing products sold as dietary supplements that contain androstenedione and warning them that they could face enforcement actions if they do not take appropriate actions.
Ephedra
Researchers have known for years about the dangers of ephedra, which contains the chemical ephedrine. The latter was used as an asthma drug until the early 1980s, when doctors stopped prescribing it because of its dangerous effects on the heart and blood pressure. The synthetic form of another ephedra ingredient, pseudoephedrine, is still used in many over-the-counter decongestants, which carry strong warning labels and are meant for only short-term use.
The FDA has been collecting and receiving reports of adverse ephedra side effects since 1994, and in a September 1994 FDA Medical Bulletin, the agency reported the number was increasing.
The reported reactions varied from mild ephedra side effects to very serious conditions including:
- Nervousness
- Dizziness
- Tremor
- Alterations in blood pressure or heart rate
- Headache
- Gastrointestinal distress
- Chest pain
- Myocardial infarction
- Hepatitis
- Stroke
- Seizures
- Psychosis
- Death
Popular Products Containing Ephedra:
- Metabolife
- Ripped Fuel
- Diet Fuel
- Stacker 3
- NaturalTRIM
- Hydroxycut
- Xenadrine RFA-1
- Metab-O-Lite
- Metabolift
- Truckers Luv It
- Yellow Jackets
The Food and Drug Administration is planning to move beyond its recent actions on ephedra and step up its scrutiny of the health effects of various other herbal supplements. If you think you have suffered a serious harmful effect or illness from a dietary supplement, contact us to schedule a free initial consultation.
To find answers to Frequently Asked Questions regarding dietary supplements, and to learn what your case might be worth, click below to fill out our free case evaluator.
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