Brewery Ordered to Stop Production of CBD-Infused Beer, FDA Warns Supplement Companies Over Sun Products

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.

“We look forward to working with the FDA to figure out how we can best describe the benefits of Sunsafe Rx and continue to offer it to customers as another tool in their arsenal to help combat the damaging effects of the sun,” Napa Valley Bioscience said. “Skin damage from the sun has reached unprecedented levels in the U.S., and we need all the help we can get.”

None of the other three companies immediately responded to requests for comment.

CV Sciences Posts Quarterly Profit, Doubles Sales

CV Sciences Inc. (OTCQB: CVSI), the distributor of hemp-based PlusCBD Oil, reported a 114 percent increase in sales in the first quarter over the prior year.

In the three months that ended March 31, 2018, the company reported net income of US$619,334 on sales of $8.07 million. In the first quarter of 2017, CV Sciences reported a net loss of $3.78 million on sales of $3.76 million.

Sales reflected “continued organic expansion into all sales channels, including the natural product retail, wholesale and direct-to-consumer channels,” the company reported in a May 15 news release, announcing its quarterly financial results.

“We are off to a strong start for 2018, delivering record financial performance on all of our key metrics, including triple-digit year-over-year revenue growth and double-digit sales growth on a sequential quarterly comparison,” said Joseph Dowling, chief financial officer of CV Sciences, in a statement. “Our operating performance is driven by a combination of core revenue growth, strong demand for our products, and a market that is still in its infancy stages.”

CV Sciences sells hemp-based CBD products to consumers through health food stores and other distribution channels. Its natural product retail channel covers 1,771 locations across the United States.

The company also operates a distinct business segment focused on developing and commercializing novel therapeutics using synthetic CBD. Dowling reported the company “made steady progress” to advance CVSI-007, its proprietary lead drug candidate. CV Sciences has described the product as “a chewing gum containing nicotine and synthetic CBD to support cessation of smokeless tobacco use and addiction.”

House Rejects Farm Bill

The House of Representatives on May 18 rejected passage of a farm bill, comprehensive legislation impacting various policies from food stamps to a U.S. Department of Agriculture subsidy program.

Republican leaders “were unable to placate conservative lawmakers demanding commitments on immigration,” and 30 Republicans joined 183 Democrats to vote against the bill in a 213 to 198 vote, The Washington Post reported.

On Feb. 7, President Barack Obama signed into law the Agricultural Act of 2014. That farm bill expires Sept. 30, 2018.

The Post described the legislation in the House as a “non-starter anyway in the Senate, which is writing its own farm bill.”

“Any legislation that ultimately makes it to [President Donald] Trump’s desk will have to look more like the version in the Senate,” the newspaper wrote, “where bipartisan support will be necessary for anything to pass and there is not sufficient support for the food-stamp changes.”

Before the legislation was defeated, the House had accepted by voice vote an amendment to the farm bill offered by Rep. Mike Rogers (R-Ala.) that would allow multivitamin products to be covered under the SNAP program (previously known as “food stamps”).

“There is nothing in the Senate right now, but there is time,” Mike Greene, senior vice president of government relations for the Council for Responsible Nutrition (CRN), said in a recent article published on Natural Products INSIDER. “We need to get the Senate activated. Sen. Tim Scott of South Carolina and Sen. Martin Heinrich of New Mexico, the new champions of the supplements industry, are very interested in this. And Sen. [Orrin] Hatch is still very much a supporter of this issue. He could be very helpful.”

Senator Introduces Legislation to Combat Fraud of Organic Imports

Responding to media reports and recommendations from the USDA Inspector General, Sen. Tammy Baldwin (D-Wisc.) has introduced a bill to fight imports of fraudulent organic products.

The Organic Farmer and Consumer Protection Act is intended to ensure organic products admitted at ports of entry in the United States are authentic and to bar the entry of products labeled as organic that do not meet National Organic Program (NOP) standards, according to a May 23 news release.

Baldwin’s office cited reports from the Washington Post, Milwaukee Journal Sentinel and USDA Office of the Inspector General, which “revealed concerns about the integrity of agricultural products imported into the United States to be sold as organic.”

“This reform is about leveling the playing field to help American farmers and standing up for American consumers to ensure they are getting the high-quality, organic food products they expect,” Baldwin said in a statement.

The legislation has reportedly garnered the support of various organic farming organizations and businesses, including the Organic Trade Association (OTA), National Organic Coalition (NOC), Organic Valley, and Organic Farmers’ Agency for Relationship Marketing Inc. (OFARM).

“Our farmers deserve to have a level playing field, and organic consumers deserve to be able to trust that they are getting what they pay for when they buy organic,” Laura Batcha, executive director and CEO of the OTA, said in the senator’s news release. “Today’s organic industry operates in a growing global market. We have to modernize and get up to speed to prevent organic fraud and to ensure that every stakeholder in the organic chain is playing by the rules, and this bill takes important steps toward making that happen.”

Reporting by Josh Long