Manufacturers, distributors and marketers of dietary supplements that make outlandish claims, are manufactured under insanitary conditions, or contain hidden drugs are putting consumers’ health at risk and should be stopped.

In March, the Food and Drug Administration (FDA) announced two different dietary supplement manufacturers were hit with consent decrees of permanent injunction for repeatedly violating federal laws that posed a risk to public health.

New York-based Riddhi USA and its owner Mohd M. Alam were accused of selling adulterated and misbranded dietary supplements and are banned from making or distributing any more supplements until they comply with current Good Manufacturing Practices. “Dietary supplement companies put the public’s health at risk when they repeatedly fail to follow good manufacturing practice regulations and omit required information about the product on their labeling,” Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs, said in a news release.

Florida-based MyNixNaxs LLC, its owner Chevonne Torres, and company officer Michael Banner were ordered to stop selling their supplements after laboratory testing revealed their products contained active pharmaceutical ingredients that could be dangerous to consumers, including the erectile dysfunction drug Viagra; the stimulant sibutramine, which was sold under the brand name Meridia until it was pulled from the market for causing heart attacks and strokes; and phenolphthalein, an ingredient the FDA deemed “not generally recognized as safe and effective” after studies indicated that it could cause cancer.

Hidden Dangers

Unfortunately, this is just the tip of the iceberg. In the fourth quarter of 2017, there were four major recalls for dietary supplements, pushing them into the top category of recalled units among food products, according to Food Quality News, an online news source for the food safety and quality control industry. Most recalls were blamed on quality issues, bacterial contamination, undeclared allergens, and hidden drugs.

These issues send more than 23,000 people to the emergency department each year, according to a study co-authored by the U.S. Centers for Disease Control and Prevention (CDC) and the FDA. Nearly 10 percent of the ER visits due to dietary supplement side effects resulted in hospitalizations.

A study by Consumer Reports also found that supplements have been linked to serious injuries like organ damage, cardiac arrest, cancer and death. Those that are most often found to contain dangerous ingredients include those for weight loss, sexual enhancement, bodybuilding and energy boosting. The FDA has also warned consumers about companies that push supplements that claim to cure, treat or prevent diseases like diabetes or cancer; or assist in the treatment of opioid overdose.

“We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer,” said FDA Commissioner Scott Gottlieb, M.D., in a news release. He added, “people who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”

Who’s Watching Out for Consumers?

Federal law limits the FDA’s oversight of dietary supplements, meaning that unlike prescription drugs, manufacturers of dietary supplements do not need to prove their products are safe and effective before marketing them. Once made available to consumers, supplement makers are required to monitor and report any serious adverse events related to use of their products. However, some don’t. The FDA has the authority to conduct laboratory testing on these products to ensure they are safe, and to take action if they find them to be a risk to consumers.

The Council for Responsible Nutrition assures consumers that “overwhelmingly, dietary supplements are safe,” but agrees consumers should use caution when buying or using these products. The FDA recommends that those shopping for supplements look for possible warning signs that the products are dangerous, such as:

  • products claiming to be alternatives to FDA-approved drugs or to have effects similar to prescription drugs;
  • products claiming to be a legal alternative to anabolic steroids;
  • products that are marketed primarily in a foreign language or those that are marketed through mass e-mails;
  • sexual enhancement products promising rapid effects, such as working in minutes to hours, or long-lasting effects, such as working for 24 to 72 hours; and
  • product labels warning that you may test positive in performance enhancement drug tests.

FDA News Releases
Food Quality News
FDA Consumer Update

Roger Smith, Beasley Allen Attorney
Roger Smith

Roger was selected for Plaintiffs Steering Committee in the Mirena IUD MDL.

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