FDA Warns Five Companies for Illegal Sale of CBD Products

Nov.23.2022
FDA Warns Five Companies for Illegal Sale of CBD Products
The FDA warns five companies for illegally selling CBD products that may be confused with traditional foods and beverages.

The US Food and Drug Administration issued warning letters today to five companies illegally selling products containing cannabidiol (CBD).


Several companies have been accused of selling products containing CBD. The FDA has stated that some consumers may confuse these products with traditional food and beverages that do not contain CBD, which could lead to unintended or excessive consumption of CBD.


The FDA expressed concern in a press release about CBD-containing products that appeal to children, such as gummies, hard candies, and cookies.


On November 11th, BrandsNaturally Infused LLC, Newhere Inc. dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC, all received warning letters from an undisclosed sender.


According to the agency, the FDA has yet to find sufficient information to determine how much CBD can be consumed and for how long before it causes harm.


The organization stated that this is particularly important for vulnerable groups such as children and pregnant women. People should be aware of the potential risks associated with using CBD products.


The warning letter also outlined other violations of the Food, Drug, and Cosmetic Act, including some companies illegally selling CBD products that claim to cure, alleviate, treat, or prevent various diseases without approval and adding CBD to animal food, such as pet snacks.


The FDA has required these companies to respond within 15 business days, outlining how they plan to address the issues described in the warning letter, or providing reasoning and supporting information for why they believe their products are not in violation of the law," the agency wrote. "Failing to promptly and adequately address noncompliance may result in legal action, including product seizure and/or injunction.


Statement:


This article is compiled from information from third-party sources and is only intended for industry professionals for learning and exchange purposes.


This article does not represent the views of 2FIRSTS, and 2FIRSTS is unable to confirm the authenticity and accuracy of the content. The translation of this article is intended solely for communication and research within the industry.


Due to limitations in translation skills, the translated article may not fully express the same meaning as the original. Please refer to the original article for accuracy.


2FIRSTS maintains complete alignment with the Chinese government on any domestic, Hong Kong/Macao/Taiwan-related, and foreign statements and positions.


The copyright of the compiled information belongs to the original media and author. If there is any infringement, please contact us to remove it.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
2Firsts Compliance Solutions Hosts PMTA Briefing on FDA Review Signals After JUUL2 Authorization
Following recent FDA authorizations for JUUL2 and ZYN ULTRA, 2Firsts Compliance Solutions held an online PMTA briefing on Sept. 4 to examine what the decisions may signal about review efficiency, scientific evidence and U.S. market access. Nearly 30 participants from brands, manufacturers, compliance service providers and investment firms joined the discussion.
2Firsts Events
Sep.06
Product | IVG Launches NEXiO Prefilled Pod System, Expanding Beyond Disposable Vapes
Product | IVG Launches NEXiO Prefilled Pod System, Expanding Beyond Disposable Vapes
UK vape brand IVG has launched the NEXiO reusable prefilled pod system, expanding its product portfolio beyond disposable vape products. The device features a 1,000mAh rechargeable battery, prefilled pods with a refill reservoir structure and a claimed capacity of up to 10,000 puffs. Officially launched in the UK on July 9, 2026, NEXiO debuted with 17 flavor options, reflecting IVG’s move into reusable pod formats.
Aug.19
Italy and Greece Oppose Ireland’s Nicotine Product Bill, Raising EU Regulatory Concerns
Italy and Greece Oppose Ireland’s Nicotine Product Bill, Raising EU Regulatory Concerns
Italy and Greece have opposed Ireland’s proposed nicotine product regulations, arguing that the measures could affect EU market coordination and the free movement of products. Ireland plans to introduce stricter rules covering nicotine products including vapes and nicotine pouches, with measures involving packaging, marketing and sales controls. The dispute highlights differences among EU member states between stronger public health protections and maintaining regulatory consistency within the bloc’s single market.
Jul.29
PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
PMI Q2 Call: ZYN Growth, IQOS Pricing and a Diverging Global Tobacco Market
Philip Morris International’s second-quarter earnings call offered new detail on its smoke-free strategy. Management said it would increase U.S. investment behind nicotine pouch brand ZYN, keep IQOS focused on volume before stronger pricing, and use SENTIA, DELIA, LEVIA, VEEV and ZYN to manage tax and regulatory pressure across Japan and Europe. Analysts from Goldman Sachs, Morgan Stanley, UBS and other firms also pressed PMI on profitability, market share, cigarette resilience and the durability of its global transformation over coming quarters.
Jul.24
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13
Japan’s Heated Tobacco Tax Changes Reshape Consumer Choices, Survey Reveals Impact of Price and Income
Japan’s Heated Tobacco Tax Changes Reshape Consumer Choices, Survey Reveals Impact of Price and Income
A consumer survey by Japanese heated tobacco information platform RELAZO found that rising tobacco prices and planned heated tobacco tax changes may influence smoking decisions among Japanese consumers. The survey covered 49,879 men and women aged 20 to 69 nationwide. It found that around 40% of respondents cumulatively indicated they may consider quitting when a pack reaches ¥600 (approximately US$4.1), while nearly 90% expressed potential quitting intentions at a ¥1,000 (approximately US$6.8) price level. The survey also found significant differences by income level, with lower-income respondents showing greater sensitivity to price increases.
Jul.24