Home > Property & Casualty > The inherent risk surrounding nutraceuticals

The inherent risk surrounding nutraceuticals

pills2Nutraceuticals, a $30 billion industry in the United States, come in the form of capsules, bars, drinks, lotions, pills, and powders. The medical and therapeutic benefits they claim to offer vary from renewed sexual drive, to enhanced athletic performance, to fewer wrinkles. Many are nutritional supplements which, according to JAMA Internal Medicine, were taken by 45 percent of people to “improve” and 33 percent of people to “maintain” overall health. However, only 23 percent of products were recommended by a healthcare provider.

When taking dietary supplements, bear in mind that they are not required to be tested or registered with the United States Food and Drug Administration (FDA). The FDA’s job in oversight is primarily registering facilities, confirming those facilities are operating within proper manufacturing practices, and investigating products after they hit the shelves. Nutraceutical companies may assert that their product has been clinically tested, but no testing is authorized by the FDA. Some companies deem “clinical testing” to be giving their employees samples for a few weeks and observing their health. The responsibility of ensuring that a product is safe before it is marketed is that of the importers, manufacturers, and distributors. This system unfortunately does not prevent all companies from entering the market with potentially harmful ingredients.

Combining unproven ingredients in experimental ways happens often in the industry, and poses a real risk for manufacturers, retailers, insurers, and consumers due to the unknown effects of the product. For example, instances of children collapsing after consuming energy drinks have made news headlines and even prompted U.S. Senate inquiries. Another credible risk is contamination, which may be unintentional as a result of careless manufacturing processes, but there have been cases of intentional contamination as well. For example, a sports nutrition powder being combined with illegal amphetamines and anabolic steroids to help improve results.

However, it is very difficult to prove causation in bodily injury claims involving nutraceuticals. If a woman taking a weight loss supplement faints, hits her head, and suffers a serious injury, is the manufacturer responsible? Proving that the nutraceutical was the direct cause may be difficult or impossible, but this challenge does not grant the manufacturer immunity. The result is usually a drawn out litigation and heavy defense costs for producers and/or distributors.

An experienced WGA advisor who understands the intricacies of the nutraceutical industry is crucial to aiding your company alleviate risk and construct effective coverage.

About the Author

Ceiry A. FoxCeiry A. Fox is a Vice President at WGA and a member of the Property and Casualty Group, with a core focus on life sciences companies.

617.646.0400 | CFox@wgains.com | Connect with Ceiry on LinkedIn

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