February 20, 2003 - FDA awaits ephedra report after baseball player's death

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Belluck & Fox - New York, NY - New York - U.S. - (866) 6ACTION
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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.  ThElliotte 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. 

Product Liability - Attorney Web Links

Austin Federal and DWI Defense Attorneys – Austin law firm of  Minton, Burton, Foster and Collins practices in the areas of  DWI, felony defense,  federal defense, drug offenses,  criminal defense, and personal injury

Austin DWI Lawyers – The Austin law firm of Minton, Burton, Foster and Collins practices in the areas of dwi related boating accidents, Public intoxication, Underage Drinking, DUI Defense, and DWI Defense.

Anderson & Anderson Attorneys, LLP, Personal Injury, Social Security Disability, Workers' Compensation, Criminal Law, Traffic & DWI, North Carolina - (888) 895-2962

White & Allen, P.A., Commercial Law, Employment Law, Estate Planning, Health Care, Personal Injury, Real Estate, Criminal Law, Kinston and Snow Hill, NC - (252) 527-8000

Belluck & Fox - New York, NY - Motorcycle Accident Attorneys - U.S. - 1-866-6ACTION

Belluck and Fox - New York Mesothelioma Lawyer / New York City Asbestos Attorneys

Belluck and Fox - New York City Asbestos Attorney / New York Mesothelioma Lawyers

Birmingham Personal Injury Lawyers – Belt Law Firm, P.C. Attorneys: Car Accidents, Wrongful Death, Prescription Negligence, Workers Compensation, and Business Litigation.

Arthur M. Blue Law Office, P.A., Personal Injury lawyers, Carthage & Southern Pines, North Carolina - (910) 947-1500

Asheville Personal Injury Attorneys - The Elmore Law Firm handling accident claims, medical malpractice, nursing home abuse and other serious injury cases. (828)253-1492

Belluck Fox, New York lawyers practicing Medical Malpractice & Personal Injury such as Meridia, Kava, Mesothelioma, Asbestos, Silicosis, Crestor, Vioxx Lawyers - New York, NY - 1-866-6ACTION

Brady, Nordgren, Morton & Malone, Estate Planning, Wills & Trusts, Probate, Raleigh, NC - (919) 782-3500

Breakstone, White-Lief & Gluck, Personal Injury, Medical Malpractice, Boston, MA - (617) 723-7676

California Business Law Attorneys - The Neilsen Law Group provides legal services to the business community in Southern California.

California Criminal Defense Lawyers - The Nielsen Law Group offers criminal defense services throughout Southern California: Los Angeles Criminal Defense Lawyers, Orange County Defense Lawyers. Contact our California Criminal Defense Lawyers

California Divorce Attorneys - The Nielsen Law Group handles family law, divorce, and child custody concerns in Southern CA. Orange County Divorce Lawyers, Los Angeles Divorce Attorneys , and San Diego Divorce Lawyers . Contact our California Divorce Attorneys.

California DUI Lawyers - The Nielsen Law Group provides legal services for those accused of DUI/DWI in Southern California. Contact our California DUI Lawyers to speak with our attorneys. Los Angeles DUI Lawyers

California Injury Lawyers - The Nielsen Law Group provides legal services throughout California for personal injury, workers compensation, social security disability, family law & divorce, DUI, and criminal defense.

Cerebral Palsy Injury - Providing CP information for families and those affected by Cerebral Palsy, birth injuries, and medical malpractice; Serving the U.S., Offices in Baltimore MD, Washington DC, Philadelphia PA - 1-888-4-MEDLAW

Charleston, SC Injury Lawyers – Joe Griffth Law Firm: Personal Injury, Accidents, Criminal Defense and Commercial Litigation, South Carolina - (866) 386-6460

Chicago Personal Injury & Illinois Medical Malpractice – Salvi, Schostock & Pritchard handles Illinois birth injury claims, vehicle accidents, wrongful death and Illinois serious injury claims.

Chicago Personal Injury & Illinois Medical Malpractice – Salvi, Schostock & Pritchard handles Illinois birth injury claims, vehicle accidents, wrongful death and Illinois serious injury claims.

Columbia Injury Lawyer – Louthian Law Firm representing victims of personal injury, auto accidents, medical malpractice, and workers compensation throughout South Carolina.

Coover & Barr, LLC, Business, Commercial & Corporate Litigation, Family Law, Real Estate, Columbia, MD - (410) 997-7600

James T. Crouse, Aviation Disaster & Personal Injury Lawyer, Raleigh, NC - (919) 861-0503

Knoxville Personal Injury Lawyer and Truck Accident Attorney: Terry, Terry & Stapleton, represent victims of Car Accident, Personal Injury, Truck Accident, Workplace Injuries, Medical Malpractice, Social Security Disability, Wrongful Death and Nursing Home Injury in the Morristown and Knox County, Tennessee area.

Kansas City Missouri Lawyers – Peterson & Associates - injury accidents, prescription litigation lawsuits, and wrongful death claims. 1-877-DRUG-GIANT

Kentucky Personal Injury Lawyer – Frank Jenkins Law Office practices in the areas of wrongful death, car accidents, work related accidents, motorcycle injuries, truck accidents, and social security disability.

Kohn & Rath, Personal Injury lawyers, Hinesburg, Vermont - (802) 482-2905

Knoxville Injury Lawyer

Kraft & Associates, Social Security Disability, Dog Bites, Truck Wrecks, Auto Accidents, Personal Injury lawyers, Dallas, Texas - (800) 989-9999

The Law Office of Laura S. Jenkins, PC, Workers Comp, Social Security, Personal Injury, Business Startups, Raleigh, NC - (919) 846-7766