The FDA sent warning letters to 11 companies for using unsafe food additives, new dietary ingredients (NDI’s) not yet approved, and/or making drug claims on dietary supplement products.

“The dietary supplements sold by the companies listed above contain one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine”. One of the ingredients mentioned was Higenamine, which is known to cause adverse effects on the cardiovascular system.

The FDA also warned companies for making unsubstantiated claims in the marketing of their products. Dietary supplements are frequently warned by the FDA for making drug claims -claims intended for use in the cure, mitigation, treatment, or prevention of disease. The FDA’s perspective is simple, if you want to make a drug claim, you must have the evidence to support it and it must be submitted to the agency for review. This process can take long and be expensive, which is why it makes more sense to remove these drug claims and limit your exposure to additional regulatory scrutiny.

Bustos Law Group specializes in helping companies who sell, distribute, or manufacture supplements, achieve and maintain FDA compliance. Our team of attorneys and consultants can assist with label and ingredient reviews, SOP and cGMP compliance, on-site auditing, New Dietary Ingredient Applications and more. Schedule a free consultation using the following link: https://calendly.com/bustoslawgroup/initial-consultation?month=2022-05