Metabolife diet pills, particularly Metabolife 356, gained significant popularity in the late 1990s and early 2000s as a weight loss supplement. However, concerns regarding the safety of these pills, primarily due to the presence of ephedra, led to numerous complaints and legal battles. This article delves into the ingredients of Metabolife diet pills, their purported benefits, and the documented side effects that ultimately led to the product's decline.
What Was Metabolife?
Metabolife International was a multi-level marketing company based in San Diego, California, that manufactured dietary supplements. Founded in the early 1990s by Michael Ellis, a former police officer, the company quickly rose to prominence with its flagship product, Metabolife 356. However, the company's success was marred by controversy, including convictions for lying to the FDA, concealing evidence of ephedra's dangers, and income tax evasion.
Key Ingredients of Metabolife 356
Metabolife 356 was marketed as a bodybuilding supplement initially but was later rebranded as a diet aid in 1995. The key ingredients included:
- Ephedra: This is an herbal supplement derived from the Ephedra sinica plant, also referred to as ma huang. The active ingredients in ephedra are ephedrine alkaloids, which act as stimulants. The Chinese have used ephedra for thousands of years to clear stuffy noses and help asthmatics breathe more easily.
- Caffeine: Often mixed with ephedra to enhance its stimulant effects.
- Other Stimulants: Metabolife 356 also included caffeine or other stimulants.
Purported Benefits and Uses
Metabolife 356 was primarily marketed for:
- Weight Loss: Ephedra, the active chemical in ephedra, was believed to somewhat help with weight loss, short-term.
- Energy Boost: As a stimulant, ephedra was used to provide an energy boost.
- Athletic Performance: Some individuals, like Washington, D.C., Police Lt. Michael Smith, used ephedra supplements to enhance their workouts.
Documented Side Effects and Health Risks
Despite its popularity, Metabolife 356 was associated with a range of side effects, some of which were severe and even fatal. These side effects were documented in consumer complaints submitted to the Food and Drug Administration (FDA) and in various medical studies.
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- Cardiovascular Issues: High blood pressure was the most common reaction. Ephedra can cause severe side effects, such as heart attacks, strokes, and irregular heartbeat. A study found that Metabolife 356 increased the mean maximal QTc interval and systolic blood pressure (SBP).
- Neurological Issues: Seizures and strokes were reported among users.
- Psychiatric Issues: Symptoms such as anxiety and change in mood were noted. Psychosis and delirium following Metabolife use have also been reported.
- Sudden Death: There were a number of deaths, including sudden cardiac death when a person is apparently healthy and doing fine, and then suddenly collapses and has no measurable blood pressure or heart activity.
- Other Adverse Effects: Insomnia and jitteriness were among the milder side effects reported.
Senator Richard Durbin (D-IL) noted that Metabolife records indicated many of the significant adverse events involved consumers who were young, in good health, and taking recommended dosages. Almost 2,000 of the complaints Metabolife released this summer involve serious adverse reactions, including 20 heart attacks, 24 strokes, 40 seizures and four deaths.
FDA's Response and Regulatory Actions
The FDA faced mounting pressure to ban ephedra due to these reactions. The FDA has already banned the mix of synthetically made ephedrine and caffeine, but because Metabolife and other dietary supplements contain ephedrin derived from the herb ephedra, taking the ephedra supplements off the market is much tougher. Under a 1994 law, the FDA must prove that problems associated with ephedra supplements are caused by them. The FDA itself generally doesn't conduct clinical studies, and no one else is offering to do the studies, or pay for them.
- Initial Actions: In 1997, the FDA issued a proposed rule regarding dietary supplements containing ephedrine alkaloids.
- Ephedra Ban: The US FDA banned ephedra in April 2004.
- DSHEA: The Dietary Supplement Health and Education Act of 1994 (DSHEA) played a significant role in the regulation of dietary supplements like Metabolife 356.
Legal Battles and Consequences
Metabolife faced numerous lawsuits related to the adverse effects of its products.
- Settlements and Judgments: Earlier this week, a federal judge ordered Metabolife to pay $4.1 million to four people who suffered strokes or heart attacks after taking the company's weight loss product. The case marks the first time a suit against Metabolife has gone to trial, and the company faces dozens of other cases.
- Criminal Charges: Following the FDA's ban of ephedra, Michael Ellis was indicted on eight counts of making false statements to the FDA in an effort to obstruct regulation of ephedra. Ellis ultimately pled guilty to a single count of lying to the FDA about the adverse effects of Metabolife 356.
- Tax Evasion: Metabolife and its owner, William Bradley, pleaded guilty to tax charges.
Influence and Lobbying Efforts
Metabolife took an active role in lobbying against regulation of ephedra, forming an advocacy group called the Dietary Supplement Safety and Science Coalition and contributing heavily to Congressmen Brian Bilbray (R-Calif.) and Dan Burton (R-Ind.), among other politicians. Bilbray subsequently criticized the FDA's treatment of Metabolife and its efforts to regulate ephedra. During this period in the late 1990s, Metabolife contributed $1.6 million in soft money to both political parties, and almost $3 million to lobbyists.
Alternatives to Metabolife 356
Following the ban on ephedra, many companies began offering ephedra-free alternatives. Consumers seeking weight loss or energy enhancement were advised to explore safer, evidence-based options, such as lifestyle changes, balanced diets, and consultation with healthcare professionals.
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