The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have teamed up to send warning letters to six companies that the agencies say are unlawfully selling \u201ccopycat\u201d delta-8 THC products that are misleadingly packaged to mimic popular brands like Doritos, Cheetos and Jolly Ranchers.<\/p>\n
The market for delta-8 THC and other novel cannabinoids has rapidly expanded in recent years following the legalization of hemp and its derivatives under the 2018 Farm Bill. FDA and FTC have generally exercised discretion in taking enforcement action against businesses that are selling products containing substances like CBD or delta-8, targeting those whose packaging or claims about medical benefits are especially misleading.<\/p>\n
These latest warning letters focus on two areas of federal law. First, they allege violations of the Federal Food, Drug and Cosmetic Act (FDCA) because they contain the unapproved \u201cadditive\u201d delta-8 tetrahydrocannabinol. The officials then detail what they call \u201ccopycat\u201d products that are packaged in ways that resemble popular brands that could appeal to children and lead to accidental consumption of the intoxicating cannabinoid.<\/p>\n
\nToday, we along with the @FTC<\/a> issued warning letters to six companies for illegally selling copycat food products containing delta-8 THC. https:\/\/t.co\/LadVXlw2uZ<\/a> pic.twitter.com\/LunMXZSMLK<\/a><\/p>\n
\u2014 U.S. FDA (@US_FDA) July 5, 2023<\/a><\/p>\n<\/blockquote>\n\n
\u201cChildren are more vulnerable than adults to the effects of THC, with many who have been sickened and even hospitalized after eating \u2018edibles\u2019 containing it,\u201d FDA Principal Deputy Commissioner Janet Woodcock said in a press release on Wednesday. \u201cThat\u2019s why we\u2019re issuing warnings to several companies selling copycat food products containing delta-8 THC, which can be easily mistaken for popular foods that are appealing to children and can make it easy for a young child to ingest in very high doses without realizing it.\u201d<\/p>\n
\u201cThe products we are warning against intentionally mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging, that consumers, especially children, may confuse with traditional snack foods. We\u2019re also concerned that adults could unintentionally take them or take a higher dose than expected and suffer serious consequences. This risk is especially dangerous for those who are driving, working, or have other responsibilities. The FDA remains committed to taking action against any company illegally selling regulated products that could pose a risk to public health.\u201d<\/p>\n
The companies that received the warning letters are Delta Munchies, Dr. Smoke LLC, Exclusive Hemp Farms\/Oshipt, Nikte\u2019s Wholesale LLC, North Carolina Hemp Exchange LLC and The Haunted Vapor Room.<\/p>\n
FDA said it has received reports of \u201cserious adverse events\u201d experienced by people who consumed delta-8 products, adding that it is \u201calso concerned that companies are producing delta-8 THC in ways that could result in products with harmful contaminants.\u201d<\/p>\n
FDA sent a first batch of warning letters regarding delta-8 THC products<\/a> last year, publicizing information about what it described as unsanctioned medical claims about the items. For this round, FTC also weighed in, focusing on alleged violations related to \u201ccopycat\u201d marketing.<\/p>\n
\u201cMarketing edible THC products that can be easily mistaken by children for regular foods is reckless and illegal,\u201d Samuel Levine, director of the FTC\u2019s Bureau of Consumer Protection, said<\/a>. \u201cCompanies must ensure that their products are marketed safely and responsibly, especially when it comes to protecting the well-being of children.\u201d<\/p>\n
\nFTC sends cease and desist letters with @US_FDA<\/a> to companies selling edible products containing Delta-8 THC in packaging nearly identical to food children eat. More: https:\/\/t.co\/y54jsP6Pkg<\/a> pic.twitter.com\/PR9C8I4IWW<\/a><\/p>\n
\u2014 FTC (@FTC) July 5, 2023<\/a><\/p>\n<\/blockquote>\n\n
The businesses that received the letters must respond to both agencies within 15 days to either contest the claims or outline what they are doing to cease sales of the specific products and get into compliance. \u201cFailure to promptly address the violations may result in legal action, including product seizure and\/or injunction,\u201d FDA said<\/a>.<\/p>\n
While FDA is taking the enforcement action against a limited number of businesses, it continues to face criticism over its decision not to enact regulations to allow for the lawful marketing of CBD in the food supply or as dietary supplements. The agency said that such rulemaking will require congressional attention<\/a>.<\/p>\n
In the meantime, Rep. James Comer (R-KY), chair of the House Oversight and Accountability Committee, sent a letter to FDA Commissioner Robert Califf<\/a> in April that notified him of an investigation into the agency\u2019s \u201cinsufficient rationale for inaction\u201d on CBD regulations.<\/p>\n
Another GOP congressman, Rep. Andy Harris (R-MD), has similarly blasted FDA over the lack of cannabidiol regulations, telling the commissioner in a committee hearing in March that the inaction is \u201cdisrupting public confidence\u201d<\/a>\u00a0in its abilities.<\/p>\n
There have been repeated efforts by congressional lawmakers to fill the regulatory gap for the non-intoxicating cannabinoid.<\/p>\n
For example, Reps. Morgan Griffith (R-VA) and Angie Craig (D-MN)\u00a0reintroduced a pair of bills in March<\/a>\u00a0meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.<\/p>\n
FDA\u2019s announcement that it wouldn\u2019t be regulating CBD came days after\u00a0the agency released finalized guidance<\/a>\u00a0that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.<\/p>\n
FDA also recently touted its role helping a state agency\u00a0crack down on a company selling delta-8 THC gummies<\/a>\u00a0that they said are linked to \u201cserious adverse events.\u201d<\/p>\n
In November, the agency\u00a0sent warning letters to five companies<\/a>\u00a0that sell foods and beverages containing CBD.<\/p>\n
The agency didn\u2019t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products \u201cthat people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.\u201d<\/p>\n
All of this comes in the background of a major task for FDA:\u00a0Conducting a scientific review into marijuana, at the direction of President Joe Biden<\/a>, to aid in an assessment of its federal scheduling. FDA\u2019s recommendation won\u2019t be binding, but officials say they expect the Drug Enforcement Administration (DEA) to produce a scheduling recommendation that\u2019s consistent with their findings about its risks and benefits.<\/p>\n
Meanwhile, a top DEA official\u00a0said in May that the agency will soon be proposing new rules<\/a> to clarify that synthetically manufactured cannabinoids like delta-8 THC are prohibited controlled substances.<\/p>\n
Delta-8 THC does occur naturally in cannabis in trace amounts, and DEA has previously confirmed that\u00a0those natural constituents are uncontrolled<\/a>. But many products are being produced synthetically, through a chemical process that converts CBD into delta-8 THC.<\/p>\n
Separately, FDA released first-of-its-kind draft guidance<\/a> last month on the \u201cunique\u201d considerations that researchers should take into account when studying psychedelics, which the agency says show \u201cinitial promise\u201d as potential therapies.<\/p>\n
\nDenver Police Processed Record-Low Amount Of Illicit Marijuana As State\u2019s Legal Cannabis Market Evolves, City Report Shows<\/a><\/p>\n<\/blockquote>\n\n
Photo courtesy of Pixabay<\/a>.<\/em><\/p>\n
The post FDA And FTC Send Warning Letters About \u2018Copycat\u2019 Delta-8 THC Products Resembling Popular Food Brands Like Doritos<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
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