FDA Law

I just wanted to give you a heads up on the latest and greatest from California and some amendments to its infamous Prop 65 that are going into effect in August 2018 (less than six months). Any company with ten or more employees that operates within the state or sells products in California must provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical in an amount exceeding established standards set forth in Prop 65’s regulations. The regulations specifying warning content that provides a safe harbor under Proposition 65 are currently in transition. Under Prop 65, consumer goods sold in California generally must provide a “clear and reasonable warning” if chemicals listed by the state as “carcinogens” or “reproductive toxicants” are present above specified limits. California amended Prop 65 warning requirements in August 2016, and the changes are scheduled to go into effect in August 2018.  If you […]

On March 17, 2015, the FDA issued a warning letter to KIND LLC, because the labels1 and labeling2 of KIND’s products bore a variety of nutrient content claims but the products did not meet the requirements to make such claims.  In particular, the FDA asserted that several of KIND’s products had an implied nutrient content claim, because they bore statements suggesting that the products may have been useful in maintaining healthy dietary practices, and those statements were made in connection with claims or statements about nutrients.  Specifically, the labels of the products bore the claim “Healthy and tasty, convenient and wholesome” in connection with statements such as: “good source of fiber,” “no trans fats,” “very low sodium,” “low sodium,” “+ antioxidants,” “+ protein,” and “7g protein.” Additionally, the FDA claimed that KIND’s website stated, “There’s healthy. There’s tasty. Then there’s healthy and tasty” and “all of our snacks are pretty much […]