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Home ► Defective Product Lawsuit and Product Liability Law ► Contaminated Supplements & Contaminated Vitamins Pose Risk to Consumers
Over-the-counter daily vitamins and supplements aid in health and well-being by providing necessary nutrients for the body to function when daily dietary intake falls short. These dietary medications are designed to make up for necessary vitamins, minerals, and other naturally occurring substances that we may be lacking in our daily diet. While the science regarding the effectiveness of daily vitamins and supplements is in contention amongst dietary experts — some saying daily vitamins and supplements are as beneficial as consuming vitamins naturally through one’s diet, while others contest that the benefits are not equitable — vitamins and supplements are generally thought to be, at worst, harmless. However, new studies indicate that while the vitamins, minerals, and other naturally occurring substances found in these daily vitamins and supplements are harmless, the supplements themselves may contain dangerous and sometimes life-threatening chemicals and heavy metals that put consumers at risk. Lack of government oversite in the nutritional industry has result in dangerous, contaminated supplements and contaminated vitamins to make their way to the shelves nationwide.
If you believe that you may have been exposed to contaminated supplements or contaminated vitamins, contact the offices of TorHoerman Law today to discuss the possibility of filing a contaminated supplements lawsuit or contaminated vitamins lawsuit.
Inadequate Food and Drug Administration (FDA) oversight in premarket nutritional supplements and vitamins manufacturing can lead to potentially dangerous products being sold on the marketplace. Research has shown that some supplements and vitamins contain dangerous amounts of potentially harmful agents. For example, one study found some vitamins to contain lead, arsenic, cadmium, and other dangerous metals. Contaminated supplements pose a threat to consumers, putting them at risk of a number of serious adverse health effects, including death.
Federal law requires that every dietary supplement is labeled, either with the term “dietary supplement” or with a term that substitutes a description of the product’s dietary ingredient(s) for the word “dietary” (e.g., “herbal supplement” or “calcium supplement”).
In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace. That is usually the FDA’s first opportunity to take action against a contaminated supplement or product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
Federal law does not require dietary supplements to be proven safe to FDA’s satisfaction before they are marketed. For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to the FDA’s satisfaction that the claim is accurate or truthful before it appears on the product.
Once a dietary supplement is available for purchase, the FDA has certain responsibilities. These responsibilities include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. The FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals. However, dietary supplement manufacturers do not have to get agency approval before producing or selling these products.
There are substantial limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews for claims as resources permit. Under DSHEA, (Dietary Supplement Health and Education Act of 1994) dietary supplements are held to a different standard. Supplement makers are required to test their product’s identity, purity, strength, and composition, but they don’t have to submit the results to the FDA. They also have to notify the agency of new ingredients. But those ingredients are only reviewed for safety and are not subject to any formal stringent approval process.
Part of the problem is a lack of resources within the FDA. Since DSHEA became law, the number of supplement products has grown exponentially from 4,000 in 1994 to more than 90,000 in 2018. The FDA’s budget to monitor supplements hasn’t grown in tandem. The industry currently generates $40 billion a year; the agency’s budget for supplement regulation is but a small fraction of that amount.
To remove a contaminated supplement from the market, the FDA must show that it poses a danger to consumers once it’s already for sale. This duty falls on doctors, consumers, and supplement manufacturers to report any suspected problems. However, doctors often do not initially connect an illness to possibly-contaminated supplements. If doctors do connect the illness to contaminated supplements, the doctor might not think to call the FDA. GAO reports found that over one thousand contaminated supplement-related calls were going to poison-control centers rather than to the FDA.
Contaminants can seep into food products from naturally occurring toxic and heavy metals; contaminated soil and water from agricultural farming methods; mine tailing runoffs, as well as storage, silos and transportation systems that can transfer contaminants as food is stored and transported. Relaxed oversight in production can allow contaminated supplements to reach the marketplace.
The Clean Label Project’s Protein Powder Study for 2018 displayed that of the top 234 selling protein powders a staggering 70% contained detectable amounts of lead, 74% contained detectable amounts of cadmium and 55% had datable amounts of BPA. BPA is known to cause cancerous tumors, birth defects, and developmental disorders. One of the protein powders tested was found to have 25 times the allowed regulatory limit of BPA in just one single serving. The protein powders that were the most contaminated were the powders sourced with a plant-based protein. In fact, 75% of the plant-based powders tested positive for lead contamination. The powders that were the least contaminated were sourced with egg as a protein source.
Protein powder supplements contaminants are the result of sourcing and production practices. Contaminants can be found in soils because of pesticides and mining run-off (ex. heavy metals) and can be absorbed into plants. Contamination can also occur because of the manufacturing process (ex. BPA/BPS is using the lining of cans and containers and leach into the protein powder.) BPA is an industrial chemical that has been used to make certain plastics and resins since the 1960s.
A nutritional industry analysis conducted by California health scientists found a staggering 800 dietary supplements sold in U.S. stores contained unapproved ingredients, including ingredients specifically prohibited or banned by the FDA. Other over-the-counter supplements contained active materials that require a prescription, such as steroids.
Last Modified: March 29th, 2019 @ 04:03 pm
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