Pharmaceutical

FDA cracks down on dietary supplement makers

ocean 315x210 FDA cracks down on dietary supplement makers The Food and Drug Administration (FDA) is cracking down on the makers of dietary supplements that make false and outlandish claims about their products.

California-based VitaSea Products Int’l Inc., also known as Wachters Organic Sea Products, claims on its website that its founder, Dr. Joseph Wachter Sr., who was diagnosed with tuberculosis and given just six months to live, healed himself with “sea vegetation.” After his recovery, Wachter founded the company in the 1930s. Watchers Organic Sea Products now sells seaweed-based products, including Sea Green Drink, Sea Kenz with Phytoenzymes and a tablet called Migraine-B-Gone, touted as a cure-all for everything from sprains and digestive disorders to cancer and HIV.

The FDA sent Wachters Organic Sea Products a warning letter on March 8, informing the company that based on the claims it is making about its products, the FDA considers them to be unapproved drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA also issued a warning to Northfield, N.H.-based Herbal Energetics, for selling supplements such as X Out-Rays, an herbal remedy for so-called “radio protection,” on its website. The agency said that it considers the products to be unapproved drugs because the makers claim the products offer cures, mitigation, treatment or prevention of disease.

The FDA added in its warning letter, “introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.”

Source: Law360