A company may inquire about incorporating a probiotic strain into a food or beverage. The probiotic supplier may have documentation showing the Generally Recognized As Safe (GRAS) status of the strain. The situation may appear safe and simple, but it may not be.
The company needs to make certain the probiotic strain is GRAS for that specific food or beverage, said Justin J. Prochnow, a lawyer and shareholder for Greenberg Traurig, L.L.P., in an April 19 presentation at Ingredient Marketplace in Orlando.
Likewise, scientific studies may show a probiotic strain delivers a certain benefit. Still, companies need to be sure that the studies apply to the type of food or beverage they are using the strain in and that enough colony-forming units (c.f.u.s) of the probiotic strain are in the product to deliver the benefit.
Probiotic suppliers have been effective at showing their ingredients are GRAS for many purposes and products, Mr. Prochnow said, mentioning the Ganeden BC30 probiotic strain.
He said, “That’s a big advantage because they can go out and market that and say, ‘Hey, you can use this. You don’t have to go out and get your own GRAS report. We’ve already established it as GRAS.’”
He gave a turmeric example for benefit claims. Studies may show turmeric helps to reduce inflammation, but what if all the studies say 5 grams of turmeric is needed and a product only has 2 grams of turmeric?
“That means (the studies) are worthless to your claim because you don’t have anything that establishes your product will do that,” Mr. Prochnow said.
Food or beverage manufacturers never should claim an ingredient or product may diagnose, treat, cure or prevent a disease.
“That’s the No. 1 mantra in any claim,” he said. “If you don’t remember anything else, and you just keep that in mind, you’re about 80% to 90% of the way there in making a claim. Typically, that’s what the F.D.A. is most focused on.”
Saying probiotics treat colds or flu thus would be a disease-type claim that would draw the attention of the Food and Drug Administration, he said.
Probiotic claims often pertain to how many c.f.u.s are in a product. Mr. Prochnow mentioned a citizen petition that the International Probiotics Association sent to the F.D.A. last November. The petition requests that the amount of probiotics in dietary supplements be listed in c.f.u.s instead of mg. Two dietary supplements each may have 50 mg of probiotics, but one may have significantly fewer c.f.u.s, Mr. Prochnow said. The comment period on the petition ends May 17, he said.
Being regulatory compliant is important, “but the reality is, your bigger issue is going to be that class-action plaintiff lawyer that is looking for their next class-action lawsuit,” Mr. Prochnow said.
Law firms buy products in retail outlets, particularly in California, and then test to see if the products meet their label claims, such as having 1 billion c.f.u.s. If the products do not meet the claims, the law firms send out letters to companies, he said. Perhaps 10 companies could end up settling with a law firm for an average of $40,000 each.“They just made $400,000 for 4, 5 hours of work,” Mr. Prochnow said of the law firm.