What is in this article?:
- Melatonin-laced Lazy Cakes: supplement or adulterated food?
- Not a dietary supplement
- Drawing FDA ire
- Do we need stronger rules separating supplements and foods?
One look at these "stress-busting" brownies, and it's clear they are destined to be viewed as a snack by consumers. And yet, the manufacturer labels the product a dietary supplement. Is this a problem for consumers and industry?
Do we need stronger rules separating supplements and foods?
Over the last several years, the FDA has worked to clarify what it considers to be supplements and foods and beverages.
In December 2009, the agency issued draft guidance on how it would distinguish between liquid dietary supplements and beverages. In that document, FDA cites factors such as packaging type, serving size and use of terms drink and beverage as qualifications that cause many consumers to view a product as a beverage rather than a dietary supplement.
Regulatory experts say that, if enforced, this draft guidance could cause a number of liquid dietary supplements on the market now to require reformulation or risk being deemed an adulterated beverage product by the FDA.
As NewHope360 has reported, many in the dietary supplement industry believe the FDA's draft guidance on liquid dietary supplements is too broad and restrictive. And yet, such guidance could help address products such as Lazy Cakes, which is clearly not a dietary supplement despite its labeling.
In the end, as Ullman notes, the supplement industry is likely to take the heat for products like Lazy Cakes—especially if they are connected to adverse event reports or health safety incidents. “When some kid eats three of these and then wraps his/her car around a light pole on the way home from the prom," Ullman says, "the Congressional hearing will focus on the ‘irresponsible’ dietary supplement industry.”