Update Nov Dec 2013 - (Page 10)

Enforcement post, by a third party, stated: "PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation...Thank you AMARC[.]" FDA's warning letter suggests that it interprets a Facebook "like" as an endorsement of the statement. Whether FDA or FTC will take the same position with respect to nutraceuticals as opposed to drugs (which are within FDA's exclusive purview), remains to be seen, but the AMARC warning letter should give companies pause about "endorsing" statements about their products via social media. C. FTC Issues Some Guidance for use of Social Media Earlier this year, FTC updated its guidelines regarding e-commerce disclosures, specifically instructing that companies should be mindful that consumers will be reading the content on various types of devices (i.e. computer, smart phone, and tablet) and that all disclosures need to be clear and conspicuous regardless of the device. Additionally, FTC provided a template for disclosing ads within posts on social media platforms. For instance, a social media post by a paid spokesperson, including space-constrained messages such as Tweets, should disclose that it is a paid endorsement, as well as state typical results if the statement is a testimonial. This will affect advertisers, social media participants, bloggers and startup companies, to name a few. And it stands to reason that FTC will also expect digital advertising regarding nutraceutical products to contain full disclosure of nutritional 10 Update November/December 2013 facts and any other required information, even under Twitter's 140 character limit. One intriguing issue that remains unclear is the extent to which a company might be responsible for posts by third parties regarding product results. If the claim is made on a page belonging to the company, does the company have to follow up with a statement that results are not typical and may vary? What if a tweet is re-tweeted? Neither FDA nor FTC have officially weighed in on these issues unique to social media. D. Litigation Trends Target Nutraceutical Marketing Claims The recent influx of nutraceutical marketing litigation seems to center around two types of product claims: (1) health-related (healthy, nutritious, or wholesome) and (2) "natural." * "Healthful," "Nutritious" and "Wholesome" claims Putative class-actions have targeted health-oriented claims regarding products that contain trans fat, high amounts of saturated fat, sugar or sodium, or artificial colors or flavors. Per FDA regulation, the term "healthy" or similar terms (health, healthful, healthfully, healthfulness, healthier, healthiest, healthily, and healthiness) can be used in the content labeling if the product meets the conditions for total fat, saturated fat, cholesterol, and other nutrients defined by regulation. Classes have been successful challenging health claims even where the advertising does not expressly call the product healthy. For instance, Nutella hazelnut spread was targeted for its advertising that make Nutella seem as though it was part of a healthy, nutritious breakfast. The class plaintiffs alleged that the advertising misled consumers about the healthfulness, implying it was part of a wholesome balanced breakfast, but omitting that the nutritional value claimed was not derived from Nutella. The class plaintiffs asserted that Nutella was more analogous to a dessert topping, with high levels of fat and sugar. The company ended up settling the suit for over $3 million in 2012. * "All Natural" Some of the most common consumer actions involve "natural" claims regarding products containing genetically modified organisms (GMOs) or other synthetic or artificial ingredients, even though the packaging truthfully lists all the ingredients. FDA has declined to promulgate a regulation defining natural, but in non-binding informal policy, FDA has indicated it considers natural to mean that "nothing artificial or synthetic" (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected. FDA applied this meaning in a 2011 warning letter to a manufacturer, stating that a potato product was misbranded as "All Natural" because it contained a synthetic chemical preservative, disodium dihydrogen pyrophosphate. This non-binding guidance, however, does not have enough weight to preempt claims by consumers. www.fdli.org http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013