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Laws regulating Dietary (food) Supplements define the responsibility and / or liability of anyone with a responsibility for a supplement product -- from the supplier or manufacturer to the seller
-- if that product causes damage due to defect.
Product liability law allows liability claims based on negligence, strict liability, or breach of warranty of fitness for a particular purpose. The United States
Department of Commerce has promulgated a Model Uniform Products Liability Act (MUPLA) for voluntary use by the states.
There is no federal product's liability law. Many food supplements are not regulated (nor tested) by the Federal Food and Drug Administration (FDA). They are generally unregulated by
prescription. In fact, while many are sold over the counter in pharmacies or in health food or grocery stores, direct marketing, mass-merchandise stores and the Internet comprise almost 62% of sports supplement sales with
another 17 percent by trainers .
Examples of product liabilities in food supplements involve defective products, with these items appearing on the market with improper labeling and lack of quality control in their production. Also,
some products do not live up to their respective guarantees or warranties. A product is legally considered defective if it was made poorly or sold with flaws. A food supplement may commonly fulfill its purpose as expected but normal
use may cause discomfort, injury or even death. A supplement may also be safe if used carefully, but it may be considered defective if the manufacturer 's information on proper dosage or proper monitoring is unclear, incomplete or
incorrect or if interactions with other drugs or supplements are not mentioned. This misrepresentation concerning the product, if resulting in an injury, may entitle the plaintiff to damages.
Dietary supplements are used for many reasons. Pills, drinks, and powders are big business. In 1999, on sports supplements alone, Americans spent an estimated $1.4 billion. Many
official reports relegate the trauma, serious injury and sometimes death following the use of these supplements as due to abuse or overuse. The truth is that studies have not been done to know what is "use" and what is "abuse" or
"overuse". Labeling on these products does not reflect scientific opinion, but rather an arbitrary assignment when it comes to dosage or value. Most of the so called benefits of taking these supplements comes from anecdotal
evidence and not scientific studies.
- Sports: Some supplements supposedly increase muscle or stamina or energy. There have been reports of serious harm inflicted through use and overuse of these products.
- Weight Loss: Supplements are generally herbal stimulants, like Ephedra. These herbal stimulants act like amphetamines ("speed"). Some investigators hold them responsible
for dozens of deaths and permanent injuries
The only 'recalls' you will see on dietary food supplements will be labeled "voluntary". Current federal law does not require advance testing and when dangers and problems with supplements are
reported, the Food and Drug Administration (FDA) must prove a case against the supplement in question prior to ordering it off the market. Legally, the label may not claim that the product will treat, prevent, or cure a
disease. This has not stopped labeling with vague claims that infer great health and well-being benefits, such as "enhances energy" or "supports testosterone production." Certain manufacturers have voluntarily recalled their
supplements after the FDA has issued warnings and stated that investigations will be conducted.
Some supplements have been prominent in the news in recent times:
Androstenedione, may upset the body's hormonal balance when it metabolizes into testosterone and estrogen. There are reports of premature puberty and stunted growth in adolescents who have
taken androstenedione.
Creatine, a substance produced by the body that can help generate brief surges of muscle energy during certain types of athletic performance appears to cause rapid weight gain due to water
retention in muscles. Creatine appears to cause kidney problems in susceptible individuals. Long-term effects of creatine are unknown.
Ephedra is an herbal stimulant that acts like an amphetamine. Supposedly, this aids weight loss by speeding up metabolism and decreasing the appetite. There are reports of dozens of
deaths and permanent injuries from the use of ephedra.
3-Andro Xtreme contains large amounts of androstenedione and ephedra plus caffeine.
PC SPES (containing warfarin) and SPES (containing alprazolam) were voluntarily recalled by BotanicLab after the FDA began an investigation into the marketing of these as herbal supplements.
Triax Metabolic Accelerator (active ingredient tiratricol, generic name: triiodothyroacetic acid), marketed as a dietary supplement for weight-loss purposes. This may cause serious
health consequences including heart attacks and stroke. The FDA has determined that this product is not a dietary supplement but an unapproved "drug".
Products liability laws are designed primarily to prevent harm or to compensate a person or property for harm that has been caused. The harm or injury caused by dietary supplements is most often
physical injury and/or financial injury. These laws are generally grouped under the same category as Personal Injury Law, which is tort law.
A civil wrong, also known as a tort, is recognized by law as being grounds for a lawsuit. Sometimes these wrongs are considered crimes and punishable by imprisonment, but the primary aim of tort law
is to provide relief through compensation to injured parties for the damages they have incurred. Among the types of recoverable damages are: loss of earnings capacity, pain and suffering, and reimbursement of reasonable medical
expenses. They include both present and future expected losses. This means that a person who has been injured due to a defect in a product or a breach of an expressed or implied warranty may be able to bring a lawsuit against the
manufacturer or the seller, or anyone else in between.
Wrongful Death is also a possibility when supplements are taken improperly or not monitored properly and the end result is death. In these instances the law provides
for compensation to the victim's heirs or estate.
Torts occur through unreasonable
negligence, malicious intention or strict liability. Tort law is
state law created through state courts and generally using the Restatement
of Torts (2nd) as an influential guide.
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