As part of the ongoing efforts to eliminate harmful ingredients used in dietary products, Federal health officials have released an ingredient advisory reference tool publicly naming the manufacturers and supplements that use unlawful ingredients that could pose harm to consumers.
A Dietary Supplement Ingredient Advisory List was published by the U.S. Food and Drug Administration (FDA) on April 16, creating a first of its kind tool that will allow consumers to avoid unlawfully marketed or potentially dangerous products.
Unlike prescription drugs, dietary supplements are not required to receive FDA approval before entering the market. However, the agency can step in and take action if the products contain active, regulated drug ingredients not listed on the label, among other scenarios.
Approximately 50% of United States adults consume some sort of over-the-counter (OTC) dietary supplement, which has become a major concern of health officials due to the loosely regulated supplement market. Earlier this year, the FDA announced they would be increasing their efforts to strengthen the regulation of dietary supplements by modernizing their regulatory framework.
As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy, and the law,” Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, said in a press release. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This List is intended to get information to both consumers and industry more quickly.”
The new ingredient advisory list will alert the public when the agency becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements or contain an active ingredient not listed on the label that has been proven to cause harm to consumer. The list will also warn consumers when an ingredient does not fit the definition of a dietary ingredient and has not received pre-market approval.
The FDA also announced it was sending eight warning letters to companies marketing dietary supplements containing DMHA, which is psychoactive central nervous system stimulant that studies indicate may increase risk of high blood pressure, glaucoma, heart arrhythmia, heart attack and death.
The warning letters gives the companies 15 days from the date of receipt to inform the FDA of specific steps they will be taking to bring their products into compliance before further regulatory action is taken by officials.
A study released by the California Department of Public Health in 2018 found 776 dietary supplements manufactured by 146 different companies were cited by the FDA for containing ingredients associated with a wide variety of adverse health consequences including liver disease, kidney disease, heart disease, depression, stroke, acute liver injury, kidney failure, pulmonary embolisms, and death.
Other previous studies have found that dietary supplement use is associated with 23,000 emergency department visits and 2,000 hospitalizations in the United States each year.
Tags: Dietary Supplements