Brewery Ordered to Stop Production of CBD-Infused Beer, FDA Warns Supplement Companies Over Sun Products
In recent news, a brewery making CBD-infused beer has captured the attention of the federal Alcohol and Tobacco Tax and Trade Bureau, FDA has targeted dietary supplements allegedly making unproven claims of protecting consumers from harm due to sun exposure, and a farm bill in the House of Representatives failed to pass.
May 25, 2018
Editor's note: below is a weekly roundup of news of potential interest to the health and nutrition industry
San Francisco Brewery Ordered to Stop Production of CBD-Infused Beer
The federal Alcohol and Tobacco Tax and Trade Bureau (TTB) has ordered a brewery in San Francisco to cease production of its beers infused with cannabidiol (CBD).
The reason? The bureau requires special approval for any nonstandard beer ingredients, reported the San Francisco Chronicle. The brewery intends to comply with the bureau’s regulations, and Black Hammer Brewing can continue to sell the CBD beers it has already made, the newspaper reported.
But on May 23, the day the article was published, the TTB issued a statement on its website regarding whether it would “approve any formulas or labels for alcohol beverage products that contain a controlled substance under federal law, including marijuana.”
The bureau referenced guidance, or clarification of a new drug code (7350), from the Drug Enforcement Administration (DEA) regarding marijuana extracts. In the clarification, DEA asserted CBD is found in parts of the cannabis plant that fall within the definition of marijuana under the Controlled Substances Act (CSA).
Although DEA’s marijuana extract rule was challenged by the Hemp Industries Association (HIA) and others, a federal appeals court recently dismissed the lawsuit—largely for procedural reasons because the petitioners didn’t raise their concerns during DEA’s marijuana extract rulemaking proceeding.
“Formula approval from TTB is required before a hemp ingredient may be used in the production of an alcohol beverage product,” the bureau stated on its website. “In determining whether a hemp ingredient is allowable for use in an alcohol beverage, TTB will consult with the DEA where appropriate and defers to the DEA in its interpretation of the CSA.”
TTB also said it consults with FDA “on ingredient safety issues where appropriate,” adding, “In some cases, TTB may require formula applicants to obtain documentation from FDA indicating that the proposed use of an ingredient in an alcohol beverage would not violate the Federal Food, Drug and Cosmetic Act [FD&C Act].”
The case involving San Francisco-based Black Hammer Brewing highlights the complicated legal landscape around CBD, a cannabis-based compound in growing demand in the United States.
In a Q&A on marijuana last updated in 2017, FDA opined it is illegal to sell a food containing CBD in interstate commerce. The agency also stated CBD is excluded from the definition of a dietary supplement—a declaration members of the hemp industry contest.
FDA hasn’t explicitly articulated its stance on CBD in an alcoholic beverage, but the agency noted on its website that the TTB regulates aspects of alcohol advertising, importation, production and wholesale distribution.
Black Hammer Brewing told the San Francisco Chronicle it has released eight brews containing CBD since debuting “Toke Back Mountain,” a CBD-infused IPA, more than a year ago.
“They’ve been extremely well-received,” owner Jim Furman said in the article. “Our line of CBD beers has been our most popular line.”
FDA Issues Warning Letters to Supplement Companies Over Sun Products
Targeting allegedly unproven claims of protecting consumers from harm due to sun exposure, FDA this week sent warning letters to four companies marketing pills and capsules as dietary supplements.
According to FDA, the claims flagged in the warning letters don’t meet its standards for effectiveness and safety.
Based on current estimates, one in five Americans is at risk of developing skin cancer—the most common cancer in the United States—in their lifetime, FDA Commissioner Scott Gottlieb, M.D., said in a statement.
The companies that received warning letters “are putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer,” Gottlieb said. “These companies were instructed to correct all violations associated with their products and were advised to review product websites and product labeling to ensure that the claims they are making don’t violate federal law.”
FDA’s letters were sent to four companies: GliSODin Skin Nutrients (product: “Advanced Skin Brightening Formula”) in Toronto; Napa Valley Bioscience (product: “Sunsafe Rx”) in Santa Monica, California; Dover, Delaware-based Pharmacy Direct Inc. (product: “Solaricare”); and Sunergized LLC (product: “Sunergetic”) in Woodbury, New York.
“Sunsafe Rx is made with ingredients that published clinical studies show protect skin from sun damage,” Napa Valley Bioscience said in an email to Natural Products INSIDER, responding to a request for comment on the FDA warning letter. “On our website, we link to some of these research papers, and each one shows that one or more of the ingredients in Sunsafe Rx protects skin from UV rays. There are numerous additional independent scientific journal articles that substantiate this for every ingredient in Sunsafe Rx.”
The company said it neither markets Sunsafe Rx as a sunscreen nor advises consumers that they don’t need to use a topical sunscreen or any other protection from the sun.