FDA Issues Warning Letters Against Delta-8 THC Gummies

Seth Goldberg
Seth A. Goldberg

I previously wrote about the American Trade Association for Cannabis & Hemp’s policy paper that called for the federal and state regulation of hemp -synthesized intoxicants like Delta-9 and Delta-10 THC, issued on June 24, 2023.   Last week, the FDA issued warning letter to six different manufacturers of gummies containing Delta-8 THC:  Delta Munchies, Dr. Smoke LLC (also known as Dr. S LLC), Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC and The Haunted Vapor Room. 

The warning letters explain that the products at issue are adulterated under the Food, Drug and Cosmetics Act, because Delta-8 THC has not been authorized by the FDA as a “food additive.”  They note that the FDA has received numerous adverse event reports pertaining to products containing Delta-8 THC, especially such products ingested by children, and emphasize the FDA is particularly concerned about the marketing of gummies containing Delta-8 to children.   In this connection, the warning letters also claim the products at issue were marketed in a deceptive manner in violation of the FTC Act.  

The manufacturers were told to cease and desist the sale of the allegedly offending Delta-8 containing products.  The warning letters will likely result in further investigation by the FDA and a process by which the manufacturers will work with the FDA to resolve the issues raised in the warning letters.

Bi-Partisan Legislation to Legalize Cannabis in Pennsylvania Proposed

Seth Goldberg
Seth A. Goldberg

Pennsylvania Senators  Dan Laughlin (R) and Sharif Street (D) have proposed legislation to legalize cannabis in Pennsylvania.  Senate Bill 84 includes an 8% sales tax, 5% excise tax, restrictions on marketing to youth, expungement of prior cannabis convictions, and other social justice measures, such as social and economic equity licenses.  Given the legalization of cannabis in Pennsylvania-border states, such as New York, New Jersey, Delaware, Maryland, and Ohio, the legalization of cannabis in Pennsylvania is necessary to ensure PA cannabis consumers purchase their products in state, which will allow the Commonwealth to enjoy the associated tax revenue, and PA residents to enjoy the economic benefits, such as more jobs and construction, associated with expanding the current medical marijuana program.

ATACH Calls for the Regulation of Hemp-Synthesized Intoxicants

Seth Goldberg
Seth A. Goldberg

Since the legalization of Hemp under the 2018 Farm Bill, a market has grown  for products that synthesize Hemp-derived compounds into intoxicants that provide a high for consumers.  Manufacturers of such products claim they are legal because they were synthesized from federally legal Hemp.  Because FDA and most states do not have regulations specifically addressing such Hemp-synthesized intoxicants, products containing Delta-8, Delta-10 and a synthesized version of Delta-9 are being marketed widely, and with little, if any, federal or state regulation.  Consequently, such products propose a health and safety risk to consumers, and undermine state-legal cannabis programs throughout the U.S.  Last week, the American Trade Association for Cannabis & Hemp issued a comprehensive policy paper calling for the regulation of Hemp-synthesized intoxicants.  ATACH urged federal and state lawmakers, as follows:

    • Amend the definition of hemp to account regulation for final product

    • Adopt standards for all intoxicating cannabinoids, whether from marijuana or hemp

    • TTB should regulate intoxicating products in adult-use settings

    • FDA should provide a pathway for non-intoxicating cannabinoids such as CBD

    • State labs should be provided with federal technical assistance

    • Retail sales should be limited to adults 21 or over anywhere intoxicants are available

    • Intoxicating cannabinoid products should be regulated in marijuana programs

    • Regulators should adopt uniform testing and labeling standards

    • Enforcement efforts should be supported, and regulations should promote public health and safety

 

 

Why Cannabis Beverages are a Good Bet

Constellation Brands, Boston Beer, Molson Coors, PepsiCo, Jones are some of the beverage companies betting on drinks with THC or CBD, adding them to their beverage product lines, as are cannabis drink makers like CANN Social Tonics, Keef, and Artet.  Here’s why:

Just about everyone enjoys socializing with a drink in their hand. Wherever people are gathering, from couples to small groups to large events, whether at a bar, cocktail party, friends/family get together, a game or other outing, most people have a drink in their hand.  Years ago cigarettes were as ubiquitous in social settings, but those days are long gone – smoking, because of its health effects and smell, has become obsolete if not shunned.   The same stigmas seem even more pronounced when it comes to smoking or vaping cannabis, plus there is the added stigma of “getting high,” which, for some reason, as a general matter, seems less socially acceptable than “getting drunk.”  Cannabis drinks are not burdened by these stigmas.

Moreover, just like alcoholic beverages, cannabis drinks allow the consumer more control over their psychoactive experience.  Just as consumers use beer, wine, and spirits for a range of intoxication, cannabis drinks can be consumed in the same way.  A few sips of a cannabis beverage with 10 mgs of THC may be enough for some to get a slight euphoric buzz that does not interfere with their socializing like a beer or two might give someone a slight buzz that does not interfere with their socializing.  In this way, cannabis beverages stand in contrast to high-THC products like vapes, butter, and shatter, just as shots of tequilla, vodka, and jager stand in contrast to beer and wine.

Cannabis drinks are a good bet because they largely avoid the stigmas of smoking and getting high, and, in so doing, make THC and CBD accessible to consumers who have withheld from using cannabis because of them.  Add to that the flexibility and control of micro-dosing, and cannabis drinks become more appealing to more people in more social situations.  This is why beverage companies and cannabis companies are betting on cannabis drinks.

 

Duane Morris LLP Named American Trade Association for Cannabis & Hemp’s “National Law Firm Partner”

Duane Morris LLP and the American Trade Association for Cannabis & Hemp (ATACH) today announced the first-ever partnership agreement between an American Lawyer (Am Law) 100 law firm and a cannabis trade association. Duane Morris LLP is a law firm with more than 800 attorneys in offices across the United States and internationally. It marks the largest and most significant law firm partnership with a cannabis trade association to date.

Read the full announcement on the ATACH website.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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