TAAT hemp cigarettes’ unsubstantiated cessation and harm reduction claims

Abstract

Introduction:

The United States Food and Drug Administration (FDA) has the authority to prohibit companies from making unauthorized harm reduction claims about tobacco products. The 2018 Farm Bill removed hemp products containing no more than 0.3% delta-9-tetrahydrocannabinol (THC) from regulation as Schedule I controlled substances. Hemp cigarettes that contain no tobacco or nicotine and less than 0.3% THC fall into a loophole in federal law and may evade federal tobacco and drug regulation despite potential health harms.

Methods:

In August-September 2024, we analyzed TAAT’s consumer website to determine whether the manufacturer made 12 marketing claims related to harm reduction or therapeutics that may lead customers to believe that TAAT’s are safe, safer than other cigarettes, or useful for cessation.

Results:

We found 307 (36.1%) of 851 sentences on TAAT’s website included one or more harm reduction or therapeutic claims. Of the 519 claims identified, the most frequent were for cessation/tobacco/smoking alternative (35.3%), no nicotine (10.2%), no tobacco (8.5%), hemp/CBD/ reduced THC (7.3%) and less harmful/better/wellness (6.2%). The website did not provide independent verification to support claims.

Conclusions:

TAAT’s website contains hundreds of unsubstantiated harm reduction and therapeutic claims. While TAAT hemp cigarettes have evaded the FDA regulations that apply to tobacco and drug products, FDA can enforce laws prohibiting TAAT from making unauthorized therapeutic claims for unapproved products and the Federal Trade Commission can take action for deceptive health claims. States and localities can also prohibit TAAT from marketing cigarettes with unsubstantiated claims.

Introduction:

Hemp products are regulated as cannabis under Schedule I of the federal Controlled Substances Act¹ if they contain more than 0.3% delta-9- tetrahydrocannabinol (THC), the psychoactive component of cannabis. The 2018 Farm Bill² removed hemp products containing no more than 0.3% THC from regulation as a Schedule I controlled substance, spurring growth of consumer hemp products, including hemp cigarettes. Because hemp-derived cannabis products with legal levels of THC can easily be converted to psychoactive delta-9-THC,^{3, 4} use of these products is increasing in states where psychoactive recreational cannabis products are illegal,⁵ including among adolescents.⁶ As of January 2025, 38 states have legalized medical cannabis and 30 legalized recreational cannabis use.⁷ With cannabis legalization,⁸ there is a growing perception that smoking cannabis is safer than smoking tobacco,⁹,¹⁰ fueled by promotion of herbal¹¹ and cannabis products with unfounded health claims.¹² Because combusting herbal cigarettes produces toxic compounds and carcinogens similar to tobacco smoke, smoking herbal cigarettes may be at least as dangerous as smoking tobacco cigarettes and may have long-term health impacts.^13–15 There is increasing evidence that smoking hemp cigarettes has negative health impacts, including on the cardiovascular system.¹⁶

Capitalizing on perceptions of safety, the hemp cigarette market has been expanding.¹⁷ TAAT hemp cigarettes claim to contain no tobacco or nicotine and less than 0.3% THC, and so are not regulated as Schedule I controlled substances. Since only products that are “made or derived from tobacco, or containing nicotine from any source”¹⁸ are subject to the Food and Drug Administration’s (FDA) tobacco authorities, TAAT hemp cigarettes with no tobacco or nicotine are not regulated as tobacco products. TAATs were introduced in the US in 2020 as “safer” alternatives to tobacco cigarettes.¹⁹ TAAT’s management (TAAT’s Global Alternatives Inc. (TAAT)), is drawn from tobacco industry alumni.²⁰ Michael Saxon, who served in leadership roles at Philip Morris International (PMI) and Altria for over 20 years, joined TAAT’s Advisory Board in 2020 and was appointed as TAAT’s CEO in 2022.²¹ Former PMI commercialization executive Tim Corkum was appointed as TAAT’s Chief Revenue Officer in 2020.²² TAAT’s packaging looks similar to Marlboro cigarettes.¹⁹

Because TAATs are not tobacco/nicotine products, they are not subject to the federal laws prohibiting tobacco manufacturers from making unsubstantiated health claims. Therefore, TAAT could make marketing claims that would be illegal for tobacco cigarettes such as claiming their products could be used to aid smoking cessation. To legally market products for smoking cessation or other therapeutic purposes, manufacturers must first obtain approval from the FDA’s drug authorities,²³ and “any product, including a cannabis product (hemp or otherwise), that is marketed with a claim of therapeutic benefit, or with any other disease claim, is considered to be a drug.”²⁴ Additionally, cannabis (including hemp) products may be deemed “misbranded drugs” if their labeling fails to include adequate directions for use.²⁵ Further, products sold with unsubstantiated advertising claims that they can prevent, treat, or cure disease also violate the Federal Trade Commission Act.²⁶

The FDA has issued warning letters to companies marketing hemp-infused products with unsubstantiated therapeutic claims, stating they are unapproved new drugs, misbranded, and have unsubstantiated advertising claims. For example, the FDA stated the following claim for Rooted Apothecary’s CBD-containing product established its intended use as a therapeutic drug and therefore violated the law because the company had not obtained approval from the FDA’s drug authorities: “Instead of synthetic chemical that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”²⁷

Because of the potentially significant health harms of hemp cigarettes,^28–31 it is important to understand if these products are being marketed with claims that may lead customers to believe they are safe or useful for cessation. While many studies have analyzed health, “harm reduction,” and cessation claims made about tobacco products, there has been little research on non-tobacco/nicotine hemp cigarettes. A 2024 study examining claims made by herbal and hemp cigarette manufacturers on Amazon.com found that unauthorized smoking cessation claims were found on 78% and reduced risk claims were found on 45% of the product pages.¹¹ This study conducted an in-depth analysis of the types of harm reduction claims made by one company (TAAT) on its consumer (trytaat.com) website. Although TAAT is not necessarily a dominant market leader, understanding the types of claims made by one global company led by former tobacco executives to market its products provides a case study that can inform policy makers to regulate other harmful smoking products that fall outside of tobacco regulation, and support counter-marketing educational campaigns.

Methods:

In August-September 2024 we reviewed and analyzed 18 pages of TAAT’s consumer website (trytaat.com), including consumer reviews on 3 of TAAT’s consumer shopping pages (https://trytaat.com/collections/alltaatproducts/products/taat-original, https://trytaat.com/collections/alltaatproducts/products/taat-smooth, https://trytaat.com/collections/alltaatproducts/products/taat-menthol-pack) since they were curated and posted on TAAT’s website. The authors analyzed every sentence on each page to identify any claims that would convey that the product is safe or safer than conventional cigarettes, that the product promoted health or wellness, and/or that the product could be used for therapeutic purposes such as smoking cessation or curing or reducing the negative health impacts of addiction.

The coding guide was developed by modifying an existing coding instrument used previously in studies of nicotine^32–34 and cannabis product websites.³⁵ We focused on the aforementioned themes because under federal law, companies would be prohibited from making such claims for tobacco products unless the products either obtained approval to be sold for therapeutic purposes under FDA’s drug authorities, or if the products obtained authorization to be sold as modified risk tobacco products (MRTP) under FDA’s tobacco authorities. Based on a preliminary review of the website, the first author drafted a coding guide including claims, definitions, and examples of website text for each claim. The other investigators reviewed the draft guide and two investigators coded sample website pages to identify and discuss discrepancies with each other and with the larger study team at weekly meetings. Based on these discussions the guide was revised until consensus was reached on definitions. In March, July, and August 2024 two investigators (LL and PL) independently coded each page of the website using the revised guide. Text and images were archived. The coders discussed any discrepancies and iteratively revised the guide if necessary to ensure alignment. A third coder was available to resolve differences if the two coders were not able to come to consensus. After several iterations, we reached consensus on the 12 claims made by TAAT related to safety, health benefits (e.g. cessation), addiction or government regulation.

Coders examined each sentence on each page of the website. A sentence was defined as a set of words such as a statement, question, command, or exclamation or an image that is a complete unit in itself and conveys meaning. An image was counted as a single sentence unit, and words that were intrinsic part of the image were coded as part of the image. Each sentence was examined for the presence or absence of the 12 claims (Supplemental File 1). For example, a sentence was coded as containing a “cessation, tobacco or smoking alternative claim” if it included any reference to cessation and/or conveyed that the product can or will help a tobacco cigarette smoker quit or cut down on smoking, is used as a smoking cessation device, or is an alternative to tobacco or smoking. This definition included claims that the product can or will satisfy or reduce smoking cravings. The cessation claim could be explicit or implicit. For example, the statement, “TAATs are a great way to help you reduce your dependency on nicotine” is an explicit therapeutic claim. The sentence, “Some people are for deprivation, some people are for candy flavours and some people are for patches, gums and other crutches, but we’re for the freedom to live your life your way” was coded as an implicit cessation claim because it refers to FDA-approved cessation products such as patches and gums, and presents TAAT as an alternative to these products.

Additionally, the authors reviewed the Certificates of Analysis that were linked on TAAT packs using a QR code.

Results:

We counted 851 sentences on 18 pages of the TAAT website. Of these, we found that 307 (36.1%) of the sentences included one or more of the 12 harm reduction claims (data not displayed). We found a total of 519 claims in these 307 sentences (each sentence or image could contain more than one type of claim). The most prevalent claims were “cessation, tobacco or smoking alternative” (183/519, 35.3%), followed by “no nicotine” (53/519, 10.2%), “no tobacco” (44/519, 8.5%), “hemp, CBD, reduced THC” (38/519, 7.3%), and “less harmful, better, wellness” (32/519, 6.2%). Supplemental File 1 shows the total number of times each claim appeared on the website.

Several sentences contained multiple claims. For example, the sentence, “Made from our proprietary Beyond Tobacco^™ blend, TAATs are American made and engineered to provide smokers with the same smoking experience they are familiar with; tobacco flavor, scent and ritual with zero nicotine and zero tobacco.” contained three claims: “No tobacco” and “No nicotine” as well as “Clean, made in USA.”

Two of TAAT’s most frequently made marketing claims were that TAAT cigarettes contain no nicotine and no tobacco; the website did not provide verification or proof to support these claims. TAAT cigarette packs display a label stating: “INGREDIENTS: Contains approximately 50 MG CBD and less than 0.3 THC” and including a QR code that links to a Certificate of Analysis (COA) completed by Clip Labs for client Taat Herb Co. that purportedly documents the amount of CBD, THC, and other cannabinoids in the tested sample to demonstrate that these amounts are within the legal limit. This “QR code – link to testing of hemp” is also pictured on its website³⁶ and a link to “Review our COA” is included under “SUPPORT” at the bottom of every page.³⁷ Notably, the report by a supposedly “independent lab” was signed on 02/01/22 by “Cindy Orser, Chief of Science.” At that time, Cindy Orser concurrently served as Chief Science Advisor to TAAT Global.³⁸

The bottom of each page included identical boilerplate disclaimers and warnings including disclaimers that “TAAT is only for use by current tobacco smokers of legal age,” that statements made by the company have not been evaluated by the FDA, and that the product “is not intended to diagnose, treat, cure, or prevent any disease.” Additionally, the “Proposition 65” warning required on some products sold in California stating that the product contains chemicals known to cause cancer and birth defects or other reproductive harm and should not be used by children, people under age 21, or people who are pregnant, lactating, suffering from medical conditions, or taking medications was present. The website included the THC cannabis warning symbol required by the California Department of Cannabis Control³⁹ for all products containing THC sold in California, and the warning, “herbal cigarettes that do not contain nicotine are not safer to smoke than cigarettes that contain nicotine.”

Discussion:

For decades tobacco companies attempted to address consumers’ health and safety concerns about smoking cigarettes, including deceptive claims about “light” cigarettes and filters.^{40, 41} The 2009 federal Family Smoking Prevention and Tobacco Control Act (TCA) prohibits companies from marketing their tobacco products as therapeutic cessation aids; companies wishing to market smoking cessation aids must obtain approval under the FDA’s drug authorities.⁴² Companies are prohibited from selling tobacco products with claims that they present a lower risk of tobacco-related disease, are less harmful than commercially marketed tobacco products, contain a reduced level of or reduced exposure to a substance, and/or do not contain or are free of a substance unless they apply for and obtain MRTP authorization from the FDA.⁴³ Additionally, the TCA prohibits manufacturers from using modified risk descriptors such as “light” on cigarette packs or advertising without first obtaining permission from the FDA.^{44, 45} A few products have received MRTP authorization orders, including PMI’s IQOS heated tobacco products and Swedish Match’s Snus smokeless tobacco products.⁴⁵ A new market is emerging for products that claim to be tobacco/nicotine free but follow this long-standing playbook of tobacco/nicotine product manufacturers promoting their products with harm reduction claims.¹⁹ We identified harm reduction claims made by TAAT hemp cigarettes, which are sold in packs and cartons that look like branded cigarettes, but marketed with claims that state or imply that TAATs are healthier substitutes for addictive nicotine cigarettes.²⁰

This paper provides a qualitative analysis of the 12 most relevant claims made in TAAT’s consumer website related to health, safety or regulation that could be considered harm reduction claims. While many of these claims do not explicitly state that TAAT is “safer” or “healthier” than tobacco cigarette, the marketing claims together portray a cigarette product that current or former smokers can use to quit or reduce nicotine dependency. Products intended to be used for the treatment of tobacco dependence must be approved by the FDA,²³ and companies are prohibited from making either explicit or implicit therapeutic claims without substantiating their claims and obtaining prior approval. Because TAAT has not obtained FDA approval to sell its cigarettes for cessation, these claims are illegal and the FDA should take enforcement action. For example, TAAT’s claims about “the natural benefits of smoking hemp products derived from CBD,” that TAATs provide a “calming effect,” and that TAATs can help cure smoking addiction are illegal therapeutic claims in violation of FDA’s drug authorities similar to those made by Rooted Apothecary that triggered an FDA warning letter²⁷ that threatened seizure and/or injunction.

TAAT explicitly states that smoking hemp provides “a mild calming effect” and other “natural benefits” (therapeutic claims) and also suggests their products are safer than cigarettes because they contain “plant-based” hemp, are sourced by hemp farmers who meet “strict specifications,” and are made with clean processes.⁴⁶ TAAT’s unsubstantiated claims about the health benefits of hemp and CBD are concerning. Although hemp is no longer regulated as a Schedule I controlled substance, studies show that cannabis exposes users to carbonyl compounds and other dangerous substances,³¹ has adverse cardiovascular and pulmonary effects, adverse effects on reproduction and fertility, is linked with malignancy, and is associated with neuropsychiatric disorders and motor vehicle accidents.²⁸ Regardless of their status as controlled substances, the FDA has indicated its continuing concerns about the safety of hemp-derived CBD (including products such as TAAT that meet the statutory definition of hemp under the 2018 Farm Bill) in various agency warning letters²⁷ and consumer safety announcements.²⁹ Citing extensive scientific literature, including studies on safety related to inhalation,³⁰ the FDA concluded in 2023 that CBD products could not meet safety standards for dietary supplements or food additives.⁴⁷

TAAT’s claim, “We wanted to create an alternative that tasted, smelled, burned and acted like a tobacco cigarette to satisfy the second most compelling reason why people do not quit smoking tobacco: rituals” conveys that switching to TAAT poses less risk or is less harmful than cigarettes. This claim is similar to unauthorized MRTP claims made by electronic cigarette maker JUUL, who received a warning letter from the FDA because they had not received prior authorization to make MRTP claims.⁴⁹ However, unlike JUUL or nicotine-containing e-cigarettes regulated by the FDA’s tobacco authorities, TAAT’s hemp cigarettes purportedly do not contain nicotine and do not fall under the FDA’s tobacco jurisdiction; therefore, TAAT’s unauthorized claims have not been subjected to FDA’s tobacco enforcement. TAAT has also escaped regulation as a drug because it allegedly contains less than 0.3% THC, providing TAAT with “a lot more legal leeway for the sales, distribution, and possession” of their products.¹⁹ The FDA could take action against TAAT for making health claims without prior approval, as it has previously done against other companies.²⁷ Additionally, the Federal Trade Commission (FTC) could take action against TAAT for unlawfully advertising that its products can be used for cessation without presenting scientific evidence to substantiate these claims.^{26, 27}

Accurate and informative labeling of hemp products is an important public health issue, and the FDA has long recognized that labels are essential tools for informing and protecting consumers and enabling informed decision-making.⁵⁰ For example, in December 2024, the FDA announced a final rule for when manufacturers can use a “healthy” claim on food packages based on scientific criteria.⁵¹ Recent studies have shown that many hemp-derived products are inaccurately labeled for CBD content, including those claiming to have been tested by third-party laboratories.^{52, 53} Inaccurately labeled THC products raise health concerns because of potential liver toxicity or drug interactions with commonly prescribed medications.^{54, 55} In its warning letter to Rooted Apothecary,²⁷ FDA cited the company for marketing “misbranded drugs” in violation of federal law because the labeling on their CBD products failed to bear adequate directions for use. TAAT’s link to a laboratory certificate and report^{56, 57} conveys the idea that these products have obtained some sort of independent laboratory approval and were determined to be high quality and safe. However, since Cindy Orser, the scientist who signed the report, was also working for TAAT at the time,³⁸ this clear conflict of interest raises concerns about the legitimacy and accuracy of the report.

Although not regulated as stringently as cannabis products on the Controlled Substances list, hemp products like TAAT that purportedly contain the legal limit of THC can be unsafe. Untruthful, inaccurate, and/or unsubstantiated health-related claims in marketing materials and on labels of CBD/hemp products can be harmful by enticing consumers to forgo evidence-based cessation medications or to unwittingly use excessive amounts of CBD/hemp that could lead to other harms.⁵⁰ The FDA deems drug⁵⁸ and tobacco products⁵⁹ “misbranded” if their labeling or marketing is false or misleading in any way. Nevertheless, tobacco companies have misled consumers to believe cigarettes such as Natural American Spirit that are marketed as “natural,” “organic,” and “additive-free” are less harmful than other brands.^60–63 Similarly, TAAT’s claims that they are “natural,” “organic,” “herbal,” and “plant-based” can mislead consumers to believe they are safe.

The disclaimers at the bottom of each page stating that the FDA has not evaluated the statements made by TAAT about their products and that the products are not intended to diagnose, treat, cure, or prevent any disease do not cancel the claims made by TAAT or allow the presence of false and misleading statements. Similarly, the warning displayed in a small, nearly illegible font at the very bottom of the page that non-nicotine herbal cigarettes are not safer to smoke than nicotine cigarettes is unlikely to effectively warn consumers of the potential harms associated with smoking herbal cigarettes. Numerous claims were enhanced by large fonts or images that explicitly stated or implied that smoking TAATs can treat nicotine addiction, can help users quit smoking cigarettes, and are less harmful than smoking nicotine cigarettes.

Some states have enacted laws that seek to close gaps in federal regulation, including restrictions on sales, access to youth, labeling, and licensing.^{5, 64} For example, in September 2024 California promulgated emergency regulations requiring industrial hemp food, beverage, and dietary supplement products to have no detectable THC and created a minimum age of 21 to purchase hemp products.⁶⁵ In October 2025, California enacted legislation that prohibits the sale of inhalable cannabis products containing cannabinoids derived from hemp.⁶⁶ States and localities can also enact new or modify existing licensing laws that would require hemp cigarette retailers to prohibit sales to underage minors, prohibit sales of hemp products over a specified yield of THC, create minimum pricing, prohibit sales, and prohibit labeling and marketing that targets youth under age 21.

Limitations:

This study relies on a single website, analyzed at a single point in time. The results cannot be generalized to other manufacturers, and website contents may change. In addition, the presence and interpretation of claims on the TAAT website are subjective judgements made by coders, and while we used multiple coders and iterative discussions to resolve discrepancies, others might disagree with the coding rubric. Despite these limitations, the study found many potentially therapeutic claims were present, and it lays the foundation for future research on this topic.

Conclusion:

Because TAAT hemp cigarettes purportedly contain no tobacco, no nicotine, and no more than 0.3% hemp, to date they have evaded the FDA regulations that apply to tobacco and nicotine products as well as drugs. TAAT’s website contains hundreds of explicit and implicit health, harm reduction or therapeutic claims. To date these claims have not been substantiated or authorized. The FDA can but has yet to take enforcement actions against TAAT and the CBD/hemp business continues to grow in the United States. Further, the FTC can take enforcement action against TAAT for its misleading, untruthful, and deceptive advertising. In the absence of federal regulatory actions, state and local authorities can prohibit TAAT from marketing their products with unsubstantiated claims that could lead to adverse health effects.

WHAT THIS PAPER ADDS.

What is already known on this topic:

• The tobacco industry has a long history of promoting products as safe or less harmful than conventional cigarettes, and federal regulations prohibit marketing tobacco products with reduced risk or therapeutic claims without obtaining prior authorization from the Food and Drug Administration.

• Recreational cannabis products are legal in 30 states, and there is a growing perception that smoking cannabis is safer than smoking tobacco cigarettes.

What this study adds:

• TAAT hemp cigarettes are marketed with unsubstantiated harm reduction and therapeutic claims on its consumer website, but because they contain no tobacco or nicotine and less than 0.3% THC, they are sold legally for recreational use and have evaded federal oversight.

How this study might affect research, practice or policy:

• TAAT’s products can lead to adverse health effects and their unsubstantiated health claims can deceive consumers into believing that TAAT and similar products are safer to smoke than other products.

• This evidence supports the need for the Food and Drug Administration and/or the Federal Trade Commission to take enforcement action against products that are marketed with misleading and unsubstantiated health claims; in the absence of federal regulation, states and localities should regulate hemp cigarettes.

DATA AVAILABILITY:

The data that support the findings of this study are available from the corresponding author, Lauren Kass Lempert, upon reasonable request.