FRANKLIN SQUARE, N.Y.—FDA issued a warning letter April 4 to Driven Sports, charging that its dietary supplement CRAZE is adulterated because no new dietary ingredient notification (NDI) was filed for Dendrobex™, an ingredient the company said was sourced from Dendrobium extract.

FDA's letter stated: "To the best of FDA’s knowledge, there is no information demonstrating that Dendrobex was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered." If neither of these requirements are met, an NDI notification must be filed demonstrating the reasonable safety of the ingredient when used as a dietary ingredient.

In addition, FDA's letter said its review of scientific literature did not conclude that Dendrobium extract, the source of Dendrobex, contains phenethylamine-type alkaloids (PEAs) as indicated on the label for CRAZE; the agency asked Driven Sports to explain the presence of PEAs in Dendrobex.

Driven Sports stopped distributing CRAZE in mid-2013 after USA Today conducted an investigation into the company and its founder, Matt Cahill; the reporters stated tests conducted by U.S. Anti-Doping Agency, a government-affiliated lab in Sweden and industry competitors showed CRAZE contained undeclared N,alpha-diethylphenylethylamine (N,a-DEPA), a compound similar to methamphetamine. Driven Sports disputed the test findings, but in a statement noted it suspended production of the product while it investigated media reports surrounding the product's safety; it also did not issue a recall of the product.

INSIDER's Take:

FDA is serious about NDI notifications. Supplement companies cannot wait until FDA reissues the NDI notification draft guidance to follow the law. It seems FDA's thinking on what ingredients require an NDI notification hasn't changed since the last draft guidance, especially on the consideration of what is "present in the food supply."

FDA wants companies to prove isolated compounds actually came from the source ingredients claimed on their product labels.

A previous version of this story, posted April 15, 2014 contained several errors; INSIDER regrets the inaccuracies."