FDA Finalizes New Rule "Clarifying" When a Tobacco Product is Actually a Medical Product
The U.S. Food and Drug Administration's (FDA's) "Deeming Regulation" became effective on August 8, 2016, extending the Agency's regulatory authority over tobacco products beyond traditional cigarettes, smokeless tobacco and roll-your-own tobacco products to include "other" tobacco product categories such as cigars, pipe tobacco, hookah/shisha, electronic vapor and e-liquid products, and components and parts of such products. Now, manufacturers of newly deemed products are subject to the Tobacco Control Act (TCA) requirements, including registering U.S. manufacturing establishments, reporting ingredients and health documents to FDA, and obtaining premarket authorization.
Products made or derived from tobacco usually fall within the meaning of "tobacco products" under the TCA, and are regulated as such by FDA's Center for Tobacco Products (CTP) unless claims made for the product trigger a different regulatory classification. In FDA's final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" published on January 9, 2017, FDA is seeking to clarify when a product made or derived from tobacco would be excluded from the definition of a tobacco product, and instead subject to FDA's drug, medical device, and combination product (i.e., medical product) authority.
Determining Intended Use
Determining a product's intended use is critical to establishing whether a product made or derived from tobacco will be regulated as a medical product. A drug is defined in Section 321(g) of the Food, Drug and Cosmetic Act (FDCA), in pertinent part, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" (the "disease" or "therapeutic benefit" prong) or "articles (other than food) intended to affect the structure or function of the body of man or other animals" (the "structure/function" prong).
FDA's new rule "reiterates" that a product made or derived from tobacco will be subject to FDA's medical product authority, and not its tobacco authority, (a) if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms; or (b) if it is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. 21 C.F.R. § 1100.5.
Medical products cannot be marketed without FDA approval, which requires demonstrating, typically through significant non-clinical and clinical evaluations, that a product is "safe and effective" for its intended use. The process of getting a medical product approved for a particular indication is complicated, takes many years, and costs millions of dollars. New medical products are also approved for a particular indication, virtually always require a prescription (with adequate data and FDA approval, over-the-counter status is possible), and may not be used recreationally, as e-vapor products generally are. Additionally, the Supreme Court has said that because FDA considers tobacco to be inherently unsafe, "if tobacco products were 'devices' under the [FDCA], the FDA would be required to remove them from the market," FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 135 (2000). Although scientific research, both in the United States and abroad, supports that e-vapor products are substantially less hazardous than combustible tobacco products (see, for example, Public Health England's report finding that e-vapor products are 95% less harmful than traditional cigarettes, which was followed by the Royal College of Physicians' ground breaking report lauding the public health benefits of e-vapor products), manufacturers should understand how FDA determines a product's "intended use" and avoid making claims, statements, or taking other actions that might trigger FDA's medical product authority.
In the preamble to the new rule, FDA sought to clarify when it would consider a manufacturer to have intended to market a tobacco product in a way that satisfied either the structure/function or disease prongs of the drug definition. According to the FDA and associated court rulings, a manufacturer's intended use can be determined through "any relevant source." Common sources could be product labeling, promotional claims, or advertising. FDA has taken the position that when it is seeking to determine whether a product is intended for use as a medical product, it may consider direct and circumstantial evidence, as well as circumstances surrounding distribution of the product. 82 Fed. Reg. 2196. Any representation by a manufacturer in a public forum can provide evidence of intent, including communications and reports to other administrative agencies or a manufacturer's websites. For example, FDA has previously determined the intended use of a product based on statements made in the manufacturer's SEC filings or patent filings with the USPTO. Importantly, FDA may also look at how the product is actually being used by consumers as evidence of the manufacturer's intent.
Disease Claims (Claims of Therapeutic Benefit)
FDA further emphasized that manufacturer claims related to "smoking cessation in the context of curing or treating nicotine addiction and its symptoms" would bring a product within the disease prong of the drug or device definition. This would include claims, for example, that an e-vapor device can help a smoker quit or treat their nicotine addiction. Indeed, FDA is clear that it considers smoking cessation claims to "create a strong suggestion of intended therapeutic benefit" which would be difficult to overcome. Beyond smoking cessation or quit claims, any claims that a product may be used to diagnosis, cure, mitigate, treat or prevent of disease (particularly tobacco-related disease) would cause a product made or derived from tobacco to be a medical product.
Disease claims are not the only type of claims that might trigger FDA's medical product authority. Claims that a tobacco product affect the "structure or function" of the body in any way related to the effects of nicotine may as well. FDA's new rule states that the only nicotine structure/function claims permissible are those that were customarily used by tobacco companies to market cigarettes and smokeless tobacco prior March 21, 2000 - the date of the U.S. Supreme Court decision in FDA v. Brown & Williamson. In other words, claims that were commonly and legally made in the marketing of cigarettes or smokeless tobacco prior to March 21, 2000 will not cause products made or derived from tobacco to be marketed as medical products.
Permissible structure/function claims could relate to satisfaction, pleasure, enjoyment, or refreshment. Additionally, claims that a particular tobacco product will provide the same effects as another tobacco product may be acceptable. FDA offers several examples of such claims, such as "get your nicotine fix" or "provides smokers the same delight, physical and emotional feelings." 82 Fed. Reg. 2200.
On the other hand, statements that a product can "relieve tension" or "promote weight loss" would be considered structure/function claims that are related to the pharmacological effects of nicotine but that were not commonly and lawfully used prior to March 21, 2000. Absent evidence to the contrary, FDA would likely consider products subject to those claims to be medical products. Even if you had evidence of such claims having been made prior to March 21, 2000, FDA's position would be that such claims were not lawful.
The new rule also reminds manufacturers that claims that a tobacco product may present reduced risk or harm (compared to other tobacco products) can only be made with FDA's explicit authorization through the Modified Risk Tobacco Product (MRTP) application process set forth in Section 911 of the FDCA, as amended by the Tobacco Control Act. In addition, false or misleading claims, including unsubstantiated claims, regarding any product regulated by FDA would cause the product to be misbranded and subject manufacturers to enforcement action. 82 Fed. Reg. 2202.
Quick Tips for Compliance
Make truthful and substantiated claims, but avoid focusing on any health impact or potential reduced risk compared to other products.
Avoid making claims that could be perceived as "smoking cessation" or "quit" claims, or nicotine addiction claims.
Claims regarding "enjoyment" or "satisfaction" are permitted.
Claims about e-vapor device functions, features, and e-liquid flavors are permitted.