Dietary Supplements

A dietary supplement is defined as a substance that contains one or more dietary ingredients and is intended to supplement an individual’s diet. The Food and Drug Administration (FDA) has described the category of dietary supplements to include vitamins, minerals, herbs, amino acids, whey protein, creatine, weight loss pills and more. Supplements are usually taken by mouth as a pill, capsule, tablet, or liquid, and labeled on the packaging as a “dietary supplement.” The supplement industry has grown steadily despite widespread concerns about the safety of the products. There is evidence of more intense governmental scrutiny in recent years, particularly since 2013. Some in the industry predict a significant increase in litigation involving allegations that supplements have caused adverse health events.

Background

Supplement ingredients may receive certification as being Generally Recognized As Safe (GRAS) under the Federal Food, Drug, and Cosmetic Act. While substances added to food are generally subject to approval by the FDA before being marketed, an exception allows ingredients that qualified experts have recognized as safe when used as expected to be sold without participating in the FDA approval process. This exception also applies to substances that are not defined as food additives.

The FDA exercises authority over finished dietary supplements and ingredients under the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which is intended to keep adulterated or misbranded products from being sold. The FDA does not routinely approve dietary supplements prior to sale, depending instead on users, medical personnel and manufacturers to report incidents of adverse reactions to products as required under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

Increased national examination of dietary supplements is underway. In 2013, the FDA began testing 21 dietary supplements that claimed to be “all natural.” Nine of the supplements contained the banned ingredient Beta-methylpenethylamine (BMPEA); others had unapproved synthetic substances that had not been safety-tested for humans. The FDA seized approximately $2 million in products from one manufacturer alone. FDA investigations continued and a number of warning letters were issued in 2015, asserting that the products containing unapproved substances were rendered “misbranded” or “adulterated.”

Injuries and Damages

Litigation over dietary supplements usually includes allegations of injuries such as liver damage in the form of hepatitis, cirrhosis and general liver failure. Consumers are most likely to experience adverse side effects from dietary supplements if they are taken at high doses, or in lieu of prescribed medications. Some litigants have claimed that supplements have caused heart related injuries or death. For example, the dietary supplement ephedrine, or “ephedra,” has reportedly been linked to more than one thousand injuries and over one hundred deaths. Ephedrine is an herbal product that has been used by the Chinese for over 5,000 years, but was not sold in the United States until the late 20th century. Ephedrine acts as both a stimulant and a thermogenic that enthusiasts claim increases one’s metabolism to burn fat while retaining lean muscle mass.

In 2003, the FDA banned all sales of products containing ephedrine after it received over 16,000 adverse effect reports related to the substance.
In 2005, a federal court in Utah overturned the FDA’s decision to ban ephedra. The Utah Court found that the FDA had not provided significant evidence that ephedra in low doses constituted a health risk. The burden of proof as to product safety fell on the FDA; ephedra is classified as a dietary supplement and not subject to the same regulations as a prescription drug. The ruling was roundly criticized, and in 2006, a federal appeals court upheld the FDA’s decision to ban ephedra, finding that the FDA followed the Congressional directive to analyze the risks and benefits of dietary supplements containing ephedra in determining that there was no dosage level of ephedra that is acceptable for the market.

Recently, with the influx of influencer sponsorship, biotin supplements, sometimes referred to as vitamin B7, become immensely popular in the beauty industry. However, a 2017 FDA report warned that taking biotin supplements can alter results in a wide swath of medical tests, including ones for anemia, cancer, heart disease, pregnancy, and thyroid problems. The agency said it has seen an uptick in the number of reported adverse events—including one death—related to the vitamin's interference with lab tests.

Legislation and Regulation

With respect to adding substances to foods, the Federal Food, Drug, and Cosmetic Act sets out requirements for the certification of ingredients as Generally Recognized As Safe (GRAS). Under law, any substance purposefully added to food is considered a food additive that must be reviewed and approved by the FDA before being marketed. However, a significant exception exists for substances that have received GRAS certification because qualified experts have recognized it as safe under the conditions of expected use or the substance is excepted from the definition of a food additive. The FDA has established good manufacturing practices (GMPs) that companies must follow, as a way to ensure the identity, purity, strength and composition of their dietary supplements. These practices are the greatest measure currently in place to ensure the safety and legitimacy of these dietary supplements.

Generally, the FDA has authority over both finished dietary supplements and dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which prohibits supplement makers and distributors from marketing adulterated or misbranded products. The FDA does not examine or approve dietary supplement products before they are sold; therefore, it is critical that serious health-related illnesses or reactions be reported to the FDA by customers and health professionals. The duty to report adverse incidents related to dietary supplements is mandated by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, passed in 2006.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires Adverse Event Reporting (AER), under which manufacturers and distributors of dietary supplements are required to report, within 15 business days after being made aware of the event, serious medical problems that occur as a result of their products. Only an event described as a "serious adverse event" must be reported, the definition of which includes: "death," "a life-threatening experience," "inpatient hospitalization," "a persistent or significant disability or incapacity" or "a congenial anomaly or birth defect." An incident that "requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described" must also be reported. Any new medical information learned by a firm must be provided within a year of the first report.

The reports must be kept for six years and made available for inspection by regulators. The FDA analyzes the records during inspections of a supplement facility, checks for compliance with current good manufacturing practices, determines whether the business has submitted all required reports, evaluates any processes in place for reporting serious adverse events, and reviews labels for completeness. Labels must include a domestic contact information for users to report adverse reactions to the supplement. Submission of an adverse event report may not be construed as an admission that the supplement product caused the event.

Liability and Insurance

The legal issues related to dietary supplements are many and complex. Theories of liability are likely to include strict liability, failure to warn, undeclared substances in products, product safety, and product labeling. Other areas of potential dispute will probably include coverage, trigger and number of occurrences issues.

Generally, standard commercial general liability (CGL) coverage would respond to claims involving dietary supplements. Improved safety by the dietary supplement industry has resulted in record low minimum premiums for Product Liability Insurance in the dietary supplement space. Retailers may be able to claim coverage under the manufacturer’s policy either contractually or by the application of a vendor’s endorsement. Some policies might exclude coverage for pharmaceuticals, although it is uncertain if this exclusion would apply to dietary supplements.

There may be some instances where the insurance claim is that of a single individual who took the dietary supplement and showed an adverse reaction relatively quickly. In those cases, the trigger and number of occurrences may not be in dispute; some ephedra claims have fallen into this category. It is possible, however, that a dietary supplement suit could involve many, perhaps thousands, of people who may have taken a dietary supplement for many years and may have even stopped taking it prior to any injury manifesting itself. Were this situation to present itself and assuming the standard CGL occurrence-based wording applies, some experts believe that many of the trigger and occurrence issues would be similar to those found in pharmaceutical claims or asbestos claims.

Litigation

Defendants to lawsuits involving dietary supplements could include manufacturers, wholesalers, marketers, distributors, and the doctors or clinics that recommended the supplement. An example of the nature of dietary supplement litigation can be found in the 2015 suit filed by Oregon’s attorney general (AG) against General Nutrition Centers (GNC) alleging that the company knowingly marketed supplements that contained FDA-banned ingredients, including Beta-methylpenethylamine (BMPEA). Some companies that received FDA warning letters listed BMPEA as an ingredient, while others did not, claiming that it was an extract of the Acacia rigidula plant. The FDA stated that products containing BMPEA disguised as a plant extract were misbranded under federal statutes. GNC, according to the AG action, continued to sell BMPEA in 22 of its workout and fast-burning supplement products under the guise that it was a plant extract. The AG complaint claimed that GNC violated the Oregon Unlawful Trade Practices Act, engaging in misrepresentation of an adulterated product that contained either of two dangerous ingredients, picamilon or BMPEA, and knowingly continued selling the products after being officially warned. The AG asserted that the FDA had explicitly found that the two ingredients did not qualify as dietary ingredients under federal statute; therefore, if either is included in the ingredient list of a dietary supplement, that product is considered to be misbranded.

Recent legal trends indicate that companies should begin to look beyond regulatory compliance and consider how a “reasonable consumer” would interpret labelling claims. As labeling has evolved due to litigation, consumers must look deeper into terms to find potentially false or misleading labeling. Nearly all states have adopted the “reasonable consumer standard” as a basis for interpreting false advertising claims. This is an objective standard that does not rest on if the plaintiff was misled. In recent cases, it has been seen that even technically compliant nutrition claims must still be independently examined under consumer deception standards to assess whether there is a potentially deceptive claim.

Future Outlook

If the litigation and insurance-related experiences of the pharmaceutical industry can be used as a predictor of the future marketing and regulation of dietary supplements, it is likely that an increasing number of lawsuits will continue be filed. How the manufacturers choose to constitute and market their products will have a significant impact on what happens with respect to legal actions. For example, ephedra-type herbs have been used in several forms for thousands of years in China. Some supplement manufacturers, however, have concentrated or combined ephedra with other substances such as caffeine or aspirin to exaggerate its effects, which may have much to do with the alleged problems with ephedra. It is likely that the FDA will continue its enforcement actions across the industry, even withdrawing products from the market in the event of unforeseen adverse side effects. Insurers would benefit from monitoring this industry closely.

In the News

2015

• GNC to Strengthen Supplement Quality Controls - Anahad O'Connor, NY Times (03/30/2015)
  GNC, the country’s largest specialty retailer of dietary supplements, has agreed to institute sweeping new testing procedures on its herbal products that far exceed quality controls mandated under federal law…Experts said the announcement marked an initial but significant step forward for the $33 billion-a-year supplement industry, which is loosely regulated and plagued by accusations of adulteration and mislabeling.

Additional Items

• National Institute of Health FAQ
  Office of Dietary Supplements, Frequently Asked Questions 
• NIH Factsheet
  The National Institute of Health Office of Dietary Supplements provides a general overview of dietary supplements.