What is in this article?:
- Regulatory expert talks Dannon settlement, food safety and tainted supplements
- Food safety bill emphasizes need for better science
- Two clinical studies not the de facto substantiation requirement
- Criminal liability
Recent actions by the FDA and FTC all point to a growing need for better science to support food and dietary supplement products, says attorney James Prochnow.
Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have been coming down fast and furious on food, beverage and dietary supplement companies in recent years.
The FDA is focused on eliminating unsafe or adulterated products from the market, as was reflected in the agency’s announcement yesterday that it is stepping up actions to eradicate tainted supplement products from U.S. market. Meanwhile, the FTC is focused on ensuring companies no longer market or label their products with unsubstantiated health claims. The agency’s latest victory in this effort also came yesterday, when the Dannon Company agreed to pay a $21 million settlement with the FTC and individual state agencies over charges of deceptive advertising for its Activia and DanActive products.
NewHope360.com spoke today with longtime food and dietary supplement legal expert James Prochnow, an attorney with the law firm Greenberg Traurig, about these and other recent regulatory-related events. Below is an edited transcript of our conversation.
Dannon’s $21 million settlement is the largest of its kind involving alleged deceptive claims by a food company. What does this settlement mean for Dannon and its products?
James Prochnow: Dannon has been involved in a lot of litigation over the last year. I don’t know if this will be its last settlement, but it is another significant step in the company’s efforts to put behind it the controversy surrounding its lack of scientific support for the claims that it has made for Activia and DanActive.
Dannon maintains that it did nothing wrong regarding its DanActive claims. Why do think the company settled on everything rather than attempting to take on the FTC as POM Wonderful is doing?
JP:I think POM Wonderful reacted too quickly by filing its lawsuit against the FTC.
All of this is part of what has been to me a very obvious effort by the government agencies over the last three years to give a strong push toward both food and dietary supplement companies to get more science behind their claims. I have been advising clients for five years to do this, and every month it becomes more obvious that good science—not marginal or trick science—is absolutely necessary to sell products that people are being asked to put into their bodies. This latest Dannon-FTC consent decree is the latest punctuation mark in the call for better science. And it’s not just the government making the call—it’s also the responsible trade associations and responsible companies.