Warnings about the Use of Dietary Supplements.

While the age of health and wellness and good nutrition are upon us, the marketplace is overrun about natural supplements. 

These supplements are regulated by the Federal Food, Drug, and Cosmetic Act (FDCA). It is enforced by the Department of Justice.  Despite the regulations, supplements are sold which do not meet the requirements, nor have ever been subject to regulation.  Many are imported from foreign countries and manufactured in uninspected facilities.

 The United States Court for the Eastern District of New York has permanently enjoined a New York company and its operators from manufacturing or distributing dietary supplements unless and until they comply with the law, the Department of Justice Civil Division’s Consumer Protection Branch, and the United States Attorney’s Office for the Eastern District of New York announced today.

A complaint filed May 23, 2019, alleged that defendants Confidence USA Inc., of Port Washington, New York, the company’s president Helen Chian, and manager Jim Chao violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing adulterated dietary supplements. The complaint alleged that inspections conducted by the U.S. Food and Drug Administration (FDA) in 2016, 2017, and 2018 showed that the defendants repeatedly failed to verify that their finished dietary supplements met product specifications for identity, purity, strength, composition, and contamination limits, and failed to verify the identity of each dietary ingredient used in the manufacture of the supplements. The United States filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA.

According to the complaint, the defendants made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store.

The current opioid addiction has stimulated the marketing of some herbal compounds alleged to aid withdrawal symptoms (Kratom)

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” Ned Sharpless, the current acting FDA chief, said in a statement. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.

Kratom, the herb of last resort was used by opioid users in the period 2011-2017 despite reports of illness, and deaths.   Investigations revealed troubling incidents, side effects, and deaths of people using Kratom

District Court Orders Long Island Company and its Operators to Stop Distributing Adulterated Dietary Supplements | USAO-EDNY | Department of Justice