On the latest episode of the Ad Law Access Podcast, partner Kristi Wolff discusses FDA’s recent CBD warning letters, Commissioner nominee Dr. Stephen Hahn’s confirmation hearings, and a preview of this week’s Cannabis Law Update webinar.

On Thursday, December 5, from Noon – 1:00 Eastern we will be holding a webinar on the emerging

Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end

On June 25, 2019, Senator Ron Wyden (D-OR) issued a letter urging Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take action by addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Specifically, Senator Wyden requested that FDA issue guidance

The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) recently updated its guidance on inclusion of hemp ingredients in beverages containing alcohol. Here’s a summary:

• It remains TTB’s policy that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the federal Controlled Substances Act.
• TTB

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

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

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

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

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

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 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments.”  The appellate panel found that the lower court erred in failing to give “weight to the FDA’s analysis and concerns regarding a Proposition 65 warning and the obstacles it would pose to the fulfillment of its statutorily-driven dietary goals.”  FDA also has expressed concerns that Prop 65 warnings should be deferred given the uncertainties about the actual risks to human health from acrylamide in food.

Acrylamide — the chemical at issue in the recent Prop 65 coffee imbroglio — is not naturally present in food products but is created by the Maillard reaction, which occurs naturally between amino acids and sugars at high temperatures.  A wide variety of food products, including most prominently baked and fried starches, contain acrylamide at relatively low levels, but nevertheless in amounts that may require a Prop 65 warning.
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