Food & Drug Law Access

Insights and Analysis from Kelley Drye's International Food and Drug Law Practice

The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA has been involved in CBD enforcement for the past few years. Since the passing of the 2018 Farm Bill, which…
On March 5, 2019, FDA Commissioner Scott Gottlieb, M.D. and FDA/CFSAN Director, Susan Mayne, Ph.D., released new independent test results confirming asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.  The agency also issued a safety alert warning consumers not to use the cosmetic products sold by Claire’s that had tested positive for asbestos that, at the time, had yet to be recalled.  FDA announced a voluntary recall on March 12th. The…
The National Milk Producers Federation (NMPF) yesterday submitted a citizen petition to FDA related to the use of dairy terms such as “milk,” “yogurt,” “cheese,” “ice cream” and “butter” in the statements of identity for non-dairy plant-based substitutes. The petition argues that the use of these standardized dairy terms to name non-dairy foods falls short of FDA requirements, “falsely implies that the non-dairy substitutes are equivalent to and interchangeable with standardized dairy foods,” and “fails…
The U.S. and other companies that export foods, additives, colorings, etc. to the European Union (EU) should take notice: new legislation applicable to the agri-food industry is being billed as one of the world’s “most transparent” laws raising potential concerns about protecting proprietary information from competitors.  Controversy surrounding the use of genetically modified organisms and the associated herbicide glyphosate paved the way for a European citizens’ initiative, which ultimately led to a legislative proposal by…
This morning, the FDA announced its intention to engage in greater oversight of the dietary supplement industry.  The announcement also conveyed that the Agency had sent 12 warning letters and five advisory letters to companies over the prior two weeks.  Some of these letters were jointly issued by FDA and the Federal Trade Commission, focusing on what the two agencies consider to be illegal and deceptive claims in advertising and labeling for products intended to…
The passage of the 2018 Farm Bill capped off a momentous year for cannabidiol, or CBD, a non-psychoactive derivative of cannabis.  As we wrote about here, the year kicked off with the rescission of the Cole Memo, the DOJ’s policy statement regarding enforcement in states where cannabis is legal.  The feared enforcement uptick never materialized, though.  By mid-year, FDA approved Epidiolex, a prescription drug made from CBD isolate for treatment of rare forms of…
The DEA announced last week that it is placing certain drug products that have been approved by the FDA and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. The action places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V. Schedule V drugs are those considered to have lower potential for abuse than drugs in Schedules I – IV.  For reference, cannabis…
FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that sponsors of new drug applications may wish to consider to demonstrate the safety and effectiveness of nonprescription drugs.  In announcing the draft guidance, FDA Commissioner Scott Gottlieb explained that the agency sees an opportunity to “foster greater access to the medicines that help keep people healthy” by encouraging “innovative tools, like digital health technologies, that would…
In a remarkable and perhaps precedent-setting decision, a California appellate court sided with cereal manufacturers in ruling last week that Proposition 65 cancer warnings for acrylamide were preempted by federal policy encouraging the consumption of more whole grains.  In overturning a lower court ruling finding no preemption, the three-judge panel of the state appeals court gave remarkable deference to Food and Drug Administration policy and guidance which, the court stated, “contained persuasive reasoning why Proposition…
Earlier this month, the Food and Drug Branch of the California Department of Public Health (CDPH) updated an FAQ document relative to regulation of cannabidiol (CBD), a non-psychoactive derivative of cannabis, which has been in the news most recently relative to FDA’s approval of a CBD drug to treat rare forms of epilepsy.  CBD is also widely sold in many states, labeled as a food or dietary supplement. In the FAQ document, CDPH recited the…