2010 Wrap-Up
With 2011 nearly upon us, we have taken a look back at the news from 2010 and the posts from the inaugural year of the Essential Nutrition Law Blog and have created a list of what we feel were the top five news stories affecting the nutrition industry in 2010. Below are our choices, in no particular order. Feel free to weigh in in the comments.
1. Senator McCain’s “Dietary Supplement Safety Act”. We began the year with the threat of more stringent regulations for dietary supplement manufacturers under a bill backed by Senator McCain. The Senator backed away from the bill in March, much to the delight of Senator Orrin Hatch. This was, of course, great news for the industry.
2. Litigation for False Claims and Deceptive Advertising. We saw a number of high-profile cases in 2010 where companies were sued for false claims or deceptive advertising in connection with dietary supplements and functional foods. For example, Dannon will pay 66 million to settle a class action suit and an action brought by the attorneys general of 35 states, the FTC put an end to some claims regarding acai berries, consumers sued Coca-Cola for claims made related to Vitamin Water, and a U.S. Attorney in Wisconsin brought suit against Beehive Botanicals, resulting in federal officials seizing a number of products from the company.
3. The FDA begins enforcing GMP’s. In May, the FDA sent out its first warning letter related to a GMP inspection, indicating that the FDA is finally enforcing the GMP regulations first announced in 2007. For tips on preparing for a GMP inspection, read Jonathan Stagg's post here.
4. The November Elections. The November elections shook things up in Washington, especially in the House of Representatives, where we saw the largest shift in party control in over six decades. There has been much speculation over how this will affect legislation for the remainder of President Obama’s first term in office. In addition, most analysts predict that the results of the 2010 Census will likely favor Republicans. This change could obviously alter how the nutrition industry is perceived by federal lawmakers, and could affect legislative efforts like the Dietary Supplement Safety Act.
5. Passage of the Food Safety Bill. The year ended with the Senate passing the Food Safety Modernization Act which updates the food regulations that have been around for over 70 years. Assuming President Obama signs the Bill into law, it will bolster the FDA's ability to monitor food imports and will shift the regulatory focus to the prevention of contamination. The dietary supplement industry generally welcomes the update. For more in-depth coverage of the Food Safety Bill, visit the Food Liability Law Blog.
Dannon Forced to Open Wallet and Change Advertising (Again)
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The multinational food company Dannon agreed to a 45 million dollar class action settlement earlier this year based on consumer complaints about advertising claims regarding the health benefits of its probiotic line of dairy products. Now the company has entered into a $21 million dollar settlement with the attorneys general from 39 states. The L.A. Times reports that this is the largest-ever multistate attorney general consumer protection settlement with a food producer. The attorneys general alleged that Dannon made deceptive and unlawful claims in advertising which were not substantiated by competent and reliable scientific evidence at the time the claims were made. According to the allegations, the majority of scientific studies showed improvement in intestinal transit time when an individual consumed three servings of the probiotic products per day for two weeks, and did not support Dannon's advertised claims that one serving per day for two weeks improved digestive health. In addition, the attorneys general alleged that Dannon could not substantiate claims regarding improved immunity against the flu and common cold.
Dannon also agreed with the FTC to drop claims that the probiotic foods help prevent irregularity and offer protection against the flu and common cold. The FTC found no substantiation of these claims. This isn’t the first time Dannon has had to alter its advertising; the March settlement required Dannon to remove specific language about the health benefits of the products from labels and advertising.
Between this and the March settlement, Dannon has now agreed to pay $66 million as restitution for the misleading health claims, which comes out to about 1.3% of Dannon reported $5 billion in worldwide net sales of the probiotic line in 2009. This latest settlement should remind companies to keep state governments on the list of watchful eyes monitoring health claims related to food and supplement products.
