FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD

November 21, 2022

Today, the U.S. Food and Drug Administration (FDA) posted warning letters to five companies for illegally selling products containing cannabidiol (CBD). 

Warning letters were sent to the following companies:

• 11-11-11 Brands
• Naturally Infused LLC
• Newhere Inc dba CBDFX
• Infusionz LLC
• CBD American Shaman, LLC

These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.

The use of CBD raises safety concerns, especially with long-term use. Risks include liver injury, harm to the male reproductive system, and side effects, such as changes in alertness and other symptoms. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.

FDA experts commented on the agency’s concerns with adding CBD to food and on information they want consumers to know. View the conversation on our website.

Today’s warning letters also outline additional violations of the FD&C Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

 

FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease

Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.

The warning letters were issued to: Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; Iwi; BergaMet North America LLC; Healthy Trends Worldwide LLC (Golden After 50); Chambers' Apothecary; and Anabolic Laboratories, LLC.

“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.” 

Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.

If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.

 

11/15/2022	11/04/2022	EC Vapor LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/15/2022	10/18/2022	HolleHippos LLC	Division of Southeast Imports	Foreign Supplier Verification Program (FSVP)
11/15/2022	11/10/2022	Cali Steam, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/15/2022	10/26/2022	Lucero Produce II Corp.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
11/14/2022	11/14/2022	One Stop VAPE Shop #3 - Grove	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

 

FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters

Companies Must Stop Marketing Unauthorized Products or Risk Enforcement

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Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products. Each e-cigarette product is packaged to look like toys, food, or cartoon characters and is likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products. 

The unauthorized products described in the warning letters include e-cigarettes that: 

• Are designed to look like toys and youth-appealing electronics like glow sticks, Nintendo Game Boy, and walkie-talkies;
• Feature youth-appealing characters from TV shows, movies, and video game characters, including “The Simpsons,” “Family Guy,” “Squid Game,” “Rick and Morty,” “Minions,” and “Baby Bus;” or
• Imitate foods like popsicles.

"The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”

The FDA issued warning letters to:

• Wizman Limited doing business as Wizvapor
• Shenzhen Fumot Technology Co., Ltd. doing business as R and M Vapes
• Shenzhen Quawins Technology Co., Ltd.
• Ruthless Vapor
• Moti Global

The warning letters notify the recipients that e-cigarettes without a marketing authorization order are adulterated and misbranded, and that selling or distributing these products to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic (FD&C) Act. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition, products that appear to be misbranded or adulterated that are offered for import into the U.S. are at risk of being detained or refused admission. Retailers and distributors should communicate with their suppliers to discuss possible options for the unauthorized products in their inventory.

“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said Dr. King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.” 

Today’s warning letters mark another step in the FDA’s continued efforts to remove illegally marketed tobacco products from the market. Through Oct. 28, the FDA has issued more than 440 warning letters to firms marketing illegal e-cigarettes containing tobacco-derived nicotine, and more than 60 warning letters to firms marketing illegal products containing non-tobacco nicotine. On Oct. 18, the U.S. Department of Justice (DOJ), on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers who failed to submit premarket applications for their e-cigarette products and continued to illegally manufacture, sell, and distribute their products, despite previous warnings from the FDA that they were in violation of the law. 

 FDA is notifying consumers of a product promoted for sexual enhancement that has been found to contain a hidden ingredient and might pose a significant health risk: Sangter Natural Male Energy Supplement contains hidden drug ingredient.

Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products. 

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.

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Veterinarian Louis Grasso and Standardbred Racehorse Trainers Richard Banca and Rene Allard Sentenced For Their Roles In Racehorse Doping Scheme

 

New York Veterinarian And Racehorse Trainers Sentenced To Prison In Federal Doping Case

Veterinarian Louis Grasso and Standardbred Racehorse Trainers Richard Banca and Rene Allard Sentenced For Their Roles In Racehorse Doping Scheme

Damian Williams, the United States Attorney for the Southern District of New York, announced that defendants LOUIS GRASSO, RICHARD BANCA, and RENE ALLARD were sentenced to 50 months in prison, 30 months in prison, and 27 months in prison, respectively, for their roles in distributing adulterated and misbranded drugs in service of a racehorse doping scheme. Each defendant previously pled guilty to felony drug misbranding and adulteration charges. U.S. District Judge P. Kevin Castel imposed the sentences in Manhattan federal court.

 

FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in Dogs

Today, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in dogs. Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment of the disease.

Pancreatitis is a painful inflammatory disease of the pancreas that can be life-threatening and generally requires that dogs be hospitalized for treatment. In most cases, it occurs spontaneously. Common factors that increase the chance of developing pancreatitis include when dogs eat something outside of their normal diet (particularly fatty foods), treatment with certain medications, and diseases like diabetes mellitus. It is more common in certain breeds of dogs and in some dogs may become a recurring or chronic condition.

 

USP publishes final compounding chapters

https://www.avma.org › blog › usp-publishes-final-com...

5 days ago — The United States Pharmacopeia (USP), which sets pharmaceutical standards that apply to both human and veterinary medicine, has released final standards for ..

 

11/08/2022	07/12/2022	NatureLab Corp.	Division of Pharmaceutical Quality Operations II	CGMP/Dietary Supplement/Adulterated
11/08/2022	10/28/2022	Vape Crusades	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/08/2022	11/03/2022	The Anthos Group, Inc.	Center for Drug Evaluation and Research | CDER	Refusal to Provide Access to and Copying of Records
11/08/2022	09/06/2022	Third Synthesis Inc., dba Chicago Sweet Connections, Inc.	Division of Human and Animal Food Operations East VI	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
11/08/2022	11/02/2022	Omega & Delta Co., Inc.	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
11/08/2022	10/31/2022	Abraxis Bioscience LLC	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated

 The FDA recently issued a warning letter jointly with the Federal Trade Commission to Alternative Health Distribution LLC d/b/a CannaAid for selling unapproved and misbranded products for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims.

Fraudulent COVID-19 Products

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.

Learn More

 

• On Tuesday, the FDA issued a warning letter jointly with the Federal Trade Commission to Alternative Health Distribution LLC d/b/a CannaAid for selling unapproved and misbranded products for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
• The FDA continues to warn consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA analysis revealed these products contain hidden drug ingredients, including diclofenac, an NSAID, and dexamethasone, a corticosteroid. The FDA urges consumers taking these products to immediately talk to their health care professional to safely stop using them because suddenly stopping these drugs may be dangerous. 
  • In April 2022, the FDA notified consumers that the agency received adverse event reports, including of liver toxicity and death, associated with the use of Artri King and similarly named products. 
  • In support of public safety, and because some of these products may still be available on the market, FDA issued warning letters on October 28, 2022, to Amazon, Walmart, and Latin Foods Market for distributing various “Artri” and/or “Ortiga” unapproved and misbranded drug products. Walmart and Latin Foods Market already issued voluntary recalls for these products.