Approximately 40% of Americans use a dietary supplement, for nutrition, weight-loss, body-building, sexually enhancement, recreation, and more. Americans spent $28.1 billion on supplements in 2010. Unfortunately, these products may be tainted with hazardous drugs. Supplements also may be spiked with dosages that are several times higher than the legal limit. Dangerous supplements can cause heart attacks, strokes, kidney failure, liver damage, depression, and death .
The FDA is concerned about a potent mixture of ingredients that could increase heart-rate, blood pressure, and potentially the risk of cardiovascular events. One of the ingredients listed on the label is AMP, also known as 1,3-Dimethylbutylamine (DMBA). Earlier this year, the FDA told twelve manufacturers of DMBA-laced supplements that the ingredient is not approved for use in supplements.
The FDA took action after researchers warned that it is a chemical analogue to DMAA, a synthetic stimulant that has been linked to cardiovascular events and other side effects .
Consequently, an article I came across specifically outlined the different ways in which a claim can be made in regards to dietary supplements and the ways in which companies can be found liable.
Ways in which Companies are Liable
- Content Claims: the most basic consumer fraud allegation that can be made about a supplement manufacturer’s product is that it doesn’t contain the ingredient(s) (or the amounts of the ingredients) as stated on the product label. The content of a dietary supplement is explicitly regulated by The Nutrition Labeling and Education Act of 1990 (NLEA). Scientific studies have evaluated the accuracy of supplement ingredient content claims for well over ten years and the assertion that these products don’t contain labeled amounts of their ingredients is certainly not new.
It is incumbent upon a manufacturer to adhere to good manufacturing practices (GMPs). If these practices are followed rigorously, it is unlikely that there could be vast discrepancies between labeled content and how much of a given ingredient is actually found in the product.
- Misleading Advertising Claims: another common allegation made against dietary supplement manufacturers in consumer fraud actions is that the benefits of the product are not supported by competent and reliable scientific evidence. Supplement manufacturers are allowed to make structure function claims about their product if these claims are supported by appropriate scientific studies. A structure/function claim is one that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.
Nevertheless, advertising claims pertaining to the structure and function of the body must be supported by competent and reliable scientific evidence. We and others have written about the importance of rigorous scientific substantiation such as competent and reliable scientific evidence for dietary supplement structure/function advertising claims. This support is then used effectively in litigation challenging the validity of effectiveness advertising claims.
Interestingly, recent data support the view that products that have good scientific support for efficacy tend to do better in the marketplace.
- Product Adulteration: another legal claim related to the recent New York attorney general investigation is that some supplement products contain adulterants and contaminants. While these claims might lead to allegations of personal injury, they might also simply lead to consumer fraud claims such as a consumer claiming that he or she didn’t purchase a fish oil product that contained other adulterants. It is likely that sourcing of dietary supplement ingredients from overseas could explain the cause of these adulterants. As stated above, if a manufacturer is rigorously following GMP standards, any contaminants or adulterants should be detected.
- Personal Injury: legal claims involving dietary supplement products could take the form of personal injury product liability. Claims could involve allegations that the ingredients are present in quantities that are known to cause adverse health effects.
Toxicity from dietary ingredients in supplements has been written about in the scientific literature as well as in the more mainstream popular press. Of course, dietary supplement manufacturers should give special consideration to their products when used in special populations (e.g., the elderly, infants, children, genetically-defined subpopulations, women, etc.) for potentially idiosyncratic reactions .
Dolman Law Group Accident Injury Lawyers, PA
Until the government decides that the FDA can tighten restrictions on dietary supplement manufacturers, consumers should be cautious. The next time you’re at your local GNC or Vitamin Shoppe remember that most of the products there likely haven’t been approved for use by the FDA prior to hitting the shelves. If you do choose to use dietary supplements please do some research and educate yourself on the ingredients contained in these products and any of the possible side effects.
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If you’ve already used a product containing DMAA and suffered injury as a result, please contact the Dolman Law Group Accident Injury Lawyers, PA. Our experienced attorneys are here to give you a free consultation and case evaluation. Call us anytime at (833) 606-DRUG .
Dolman Law Group Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, Florida 33765
(833) 606-DRUG