Looser Rules For “General Wellness” Claims In FDA Draft Guidance

It’s a step in the right direction, according to a client alert from Morrison & Foerster. A draft guidance for what can be claimed about “general wellness” products will allow some statements that suggest a product has a positive effect on particular medical conditions, even if that effect is indirect. The example given by the writers is wearable exercise monitoring gear, where in addition to claiming the product will promote exercise, the company could point out that exercise may lower your blood pressure. “The shift away from needlessly regulating low-risk products, and toward allowing manufacturers to use well-known and accepted health benefits in their promotional marketing, is a welcome one,” the writes say. They also note that, while guidance documents do not create “legally enforceable responsibilities,” this particular draft includes an algorithm to help manufacturers determine if their product qualifies as a general wellness product.