FDA seeks to extinguish tobacco sales for 8 retailers

The FDA filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who repeatedly violated restrictions on the sale and distribution of tobacco products, including sales to minors. Under the law, the FDA may pursue an NTSO against retailers that have a total of five or more repeated violations of those restrictions during compliance inspections within 36 months. The FDA’s actions would prohibit the sale of regulated tobacco products at eight retail establishments located in New Jersey, Michigan, Illinois, Maryland, and Missouri for 30 days.


Under the Family Smoking Prevention and Tobacco Control Act of 2009 (P.L. 111-31) the FDA has authority to regulate the manufacture, marketing and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

After the FDA initiates an NTSO action by filing a complaint, a retailer has the ability to respond to the complaint but must generally do so within 30 days. If an NTSO becomes effective, a retailer is responsible for ensuring that the establishment does not sell regulated tobacco products during the specified period.


Removing or covering tobacco products are examples of steps that a retailer may undertake to ensure compliance with an NTSO, but these specific actions are not required. The retailer has discretion on what measures to take to ensure no regulated tobacco products are sold at the store during the period of time specified in the order. The FDA will conduct unannounced compliance check inspections during that period to check whether the establishment is complying with the terms of the order.

The FDA provides compliance education and training opportunities to retailers and monitors compliance through surveillance, inspections and investigations. When violations are found, the agency generally issues warning letters and may take enforcement actions, including civil money penalties and NTSOs. As of Oct. 1, 2015, the FDA has conducted more than 508,000 inspections of tobacco product retail establishments, issued more than 35,700 warning letters to retailers for violating the law and initiated more than 5,200 civil money penalty cases.

FDA quietly lifts knowledge-based labeling requirement from the ‘intended use’ definition for drugs and devices

On September 25, 2015, the FDA issued a proposed rule ostensibly designed to merely clarify the circumstances in which a tobacco product “intended” for human consumption will be deemed subject to regulation as a drug, device, or a combination product.  On its face, the proposed rule only affects tobacco products. However, if one reads the preamble and the proposed regulations carefully, they will see that the FDA  is also quietly proposing the amendment of the drug and device “intended use” definitions at 21 C.F.R. §§201.128 (drugs) and 801.4 (devices) to: (1) eliminate the need for a manufacturer or distributor to label a drug or device for an off-label, or unapproved, use solely because it has knowledge that the product is being prescribed or used by a physician(s) for that off-label use; and (2) to ameliorate industry fears that the FDA may deem the off-label use by a physician(s) to be an unapproved use, potentially resulting in FDA action against the manufacturer or distributor.

The original “intended use” definitions for drugs and devices were issued in on February 13, 1976 (41 FR 6911). They state that to establish a product’s intended use, and thereby determine the FDA’s regulatory authority and appropriate labeling, the FDA is not limited by the manufacturer or distributor’s subjective claims of intent, but can also consider objective evidence, such as direct and circumstantial evidence. This objective intent may be shown by labeling claims, advertising matter, or oral and written statements by the manufacturer or distributors or their representatives. It may also be shown by circumstances in which the product is, with the knowledge of the manufacturer, distributor, or their representatives, offered and used for a purpose for which it is neither labeled or advertised. This objective intent definition will not be altered if the proposed rule is finalized.

The proposed rule, however, removes the following language from both 21 C.F.R. §§201.128 and 801.4, which has been present since 1976:

“But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.”

While the FDA has never enforced this so-called ‘knowledge’ provision, this long-overdue removal of the language should eliminate any lingering doubt in the minds of industry that providing FDA-approved on-label product use information to physicians that may be prescribing the product off-label will not subject the manufacturer or distributor to criminal or civil liability, or accusations that their labeling is inadequate.  As the FDA explicitly states on page 57757 of the proposed rule: “The Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by doctors for such use [emphasis added].”

Firms, however, are not totally off the hook.  They should take note of the fact that the FDA deliberately used the word “solely.” Therefore, if something more than mere knowledge of off-label use by the physician is present, the FDA may still take action.


FDA media briefing enlightens cigarette stop order, but snuffs out tobacco deeming rule query

While an FDA media briefing managed to shed some additional light on the agency’s September 15 decision to order R.J. Reynolds Tobacco Company to stop the sale and distribution of four provisionally marketed cigarettes, the FDA was unable to respond to a question regarding when the tobacco industry can expect to see the final tobacco deeming regulations.


According to Mitch Zeller, the Director of the FDA Center for Tobacco Products, the September 15 stop order came after the FDA conducted a rigorous scientific review of R.J. Reynolds’ applications for Camel Crush Bold, Vantage Tech 13, Pall Mall Deep Set Recessed Filter Menthol, and Pall Mall Deep Set Recessed Filter cigarettes. The four cigarettes were allowed provisional marketing during the agency’s scientific review. According to Zeller, they were “considered provisional because they entered the market during a grace period established by the Family Smoking Prevention and Tobacco Control Act of 2009 [Tobacco Control Act].” The grace period covers products that entered the market between February 15, 2007, and March 22, 2011.

Historically, tobacco companies  could market new tobacco products without FDA review, but since enactment of the Tobacco Control Act, the FDA now requires that companies show that a provisional product is substantially equivalent (SE) to a predicate product (i.e., a product that was already commercially marketed as of February 15, 2007).  Zeller explained in the briefing that SE can be achieved by showing that the provisional product has the same characteristics as the predicate product, or if different, that the characteristics do not raise different questions of public health. According to Zeller, “the FDA’s review found just that — these four products have different characteristics than their predicates and the company did not adequately show that those differences do not cause the new products to raise different questions of public health.”

On September 8, 2015, the FDA issued a frequently asked questions guidance on how to demonstrate the SE of a new tobacco product.

Scientific Rationale

David Ashley, Director of the Office of Science at the FDA Center for Tobacco Products, elaborated on the scientific rationale for the agency’s not substantially equivalent (NSE) decision on the four applications. Ashley stated that “the reviews of these applications looked at the characteristics of the products…including…design, ingredients, materials, and composition, and how — if there are differences — it may cause the new product  to raise different questions of public health such as toxicity, addictiveness, and appeal.” This was accomplished, according to Ashley, “by evaluating the product’s engineering, chemistry, microbiology, toxicology, user behavior, addictiveness, clinical effects, and/or user and non-user perception.” Ashley concluded, that “some of the differences between the products and their predicates included findings of increased yields of harmful or potentially harmful constituents — such as toluene, formaldehyde and 1,3-butadiene — high levels of menthol, and the addition of new ingredients that could impact toxicity or appeal.”

The full decision summaries for the products are available on the FDA’s tobacco product marketing orders webpage.

Enforcement Policy

Ann Simoneau, Director of Office of Compliance and Enforcement at the FDA Center for Tobacco Products, provided information on how the tobacco industry can comply with these stop orders and how the FDA intends to enforce them. Simoneau made it clear that because R.J. Reynolds did not comply with FDA marketing requirements, the four products are now considered misbranded and adulterated. This means that it is illegal to sell or distribute them in interstate commerce, and doing so could result in FDA enforcement action, including seizure without notice.  Simoneau recognized, however, that “some retailers may have current inventories of these products with limited ways of disposing them. As such, “for 30 days the FDA does not intend to take enforcement action on previously purchased products that the retailer has in inventory.” This policy is outlined in a guidance, entitled “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.”

Media Q&A

During the question and answer session, Matt Perrone of Associated Press asked why there was a media briefing called for this action and whether R.J. Reynolds had some sort of a preliminary warning of the action. Zeller responded that the media briefing was called because “we thought that there would be more public interest in these actions because some of these are brand name products.” Zeller added that there had been a significant amount of back-and-forth between the Center for Tobacco Products and R.J. Reynolds on the products and when the FDA concluded the products’ characteristics were different from their predicates, the burden shifted to R.J. Reynolds to demonstrate that those differences did not raise different questions of public health. “Ultimately the evidence that was submitted…was inadequate to overcome the conclusion that we reached,” said Zeller.  Ashley added that “we send out a notification letter to the companies 45 days before we begin our review. So if they decide that the application they had in-house is not appropriate they can make changes during those 45 days.” In addition, Ashley noted that “companies that get an NSE decision are allowed to come back in with a new application, but that does not relieve them of the responsibility to remove the products from the market during the period before the [new] application is reviewed.”

Mike Esterl of the Wall Street Journal asked how may applications the FDA has received for SE review, how many authorizations have been given, and how many rejections have been issued.  In his response, Zeller broke the SE applications into 2 buckets: (1) regular applications for new products not currently marketed, and (2) applications for the so-called provisional products.  According to Zeller, the first bucket is the smaller of the two buckets and involves  roughly 1,100 products. To date, Zeller reported that 65 percent of the 1,100 regular SE applications have been resolved either by saying they are SE, not SE, or because the company withdrew the application.  The second bucket is much larger and involves the provisional products, such as the ones at issue. Zeller indicated that there are approximately 3,600 provisional SE applications, of which around 12 percent have been resolved by saying they are SE, not SE, or through withdrawals, and another 700 or so currently under scientific review. When pressed for more definitive numbers, Zeller said that the FDA has issued 257 SE orders, and 113 NSE orders, and about another thousand applications have been withdrawn.

Deeming Rule Query Snuffed Out

An unrelated but very important matter was raised by Lydia Wheeler of The Hill.  She asked when the FDA was going to issue its final tobacco deeming regulations. Wheeler indicated that it seems “to be taking a long time to come out and a lot of groups were hoping that they would be out by the summer and now we’re more into the fall. So, can you give us an idea when we could expect to see those?”

The deeming regulations, proposed on April 25, 2014 (80 FR 23142), would extend the FDA’s authority to cover additional products that meet the definition of a tobacco product. Currently, the FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco. Once the proposed rule is final, the FDA will be able to use regulatory tools, such as age restrictions and rigorous scientific review of newly deemed tobacco products and their claims.

The proposed rule requested comments on the FDA’s proposed options for regulation of cigars, electronic cigarettes and other non-combustible tobacco products, pathways to market for proposed deemed tobacco products, and compliance dates for certain provisions. Comments on the proposed rule, originally due by July 9, 2014, were extended to August 8, 2014 (80 FR 35711).

In response to Wheeler’s question, Zeller said “while we are not surprised that there is a question being asked about deeming, we can’t answer that question. Thank you.”  The moderator quickly adding “Next question, please.”


Study: First-time substance use among college students varies throughout year

In an announcement that is sure to send shivers down the spines of parents of college students everywhere, the Substance Abuse and Mental Health Services Administration (SAMHSA) detailed the results of its National Survey on Drug Use and Health, which examined the initiation patterns of full-time college students’ use of illicit or harmful substances. The study found that usage patterns peaked at different times of the year depending on the substance. In addition to its survey results, SAMHSA also offered resources for parents and other adults to assist them in discussing the health risks of alcohol use with their college students.


The study discovered that 383,000 full-time college students, or, 1,000 per day, used marijuana for the first time over the previous year. The peak times for the first-time use, or initiation, was in June, with 1,500 full-time students starting to use marijuana each day.


The study also found that 450,000 underage (18 to 20 years old) full-time college students, or 1,200 per day, began drinking in the previous year. The underage drinking initiation was found to peak during June, with an average of 1,883 full-times students beginning to drink each day.

Prescription Drugs

Although summer is the peak time for students to begin alcohol use, the same was not true for first-time use of prescription drugs that were taken for non-medical purposes. The study estimates that 251,000 full-time college students began using pain relievers for non-medical uses over the previous year, with an average of over 700 students beginning to use them each day. December was found to be the peak month, with 850 students beginning to use pain relievers each day.


The study also found that the non-medical use of stimulant medications peaked in November, December, and April, with 137,000 full-time students, or 400 each day, beginning the use of prescription stimulants for non-medical uses over the last year. During November, December, and April, the average daily rate of first-time users roses above 500 and peaked at about 585. The study was not designed to determine the cause of the first-time use trends, but did note that the rise in the first-time use of prescription stimulants coincided with times when midterm exams and final exams typically occurred.  This suggests that students may begin using prescription stimulants for non-medical purposes because they believe it may assist with their academic performance. SAMHSA points out that improved performance has not been proven, and use of stimulants can be dangerous.

Tobacco and Legal Alcohol Use

In addition to the above substances, the survey also looked at initiation patterns for use of legal substances that could still pose health risks to college students, including tobacco and also examined legal alcohol use by students aged between 21 and 22 years old. The study found that the peak months for first-time use of cigarettes for full-time college students were June, September, and October, while the peak month for legal alcohol use was January.

SAMHSA Acting Administrator Kana Enomoto said, “These findings show that college students are vulnerable to substance use at any time – not just when they are away at school.” Enomoto added, “That means that parents, college counselors, faculty members, staff, mentors, and other concerned people must take every opportunity to talk with college students about the risks of substance use and where they can turn to for help.”

Discussions with Students

In order to encourage parents and other adults to discuss alcohol use with college-bound young adults, SAMHSA developed “The Sound of Your Voice,”  a video and a related companion guide, which offers suggestions on how to effectively discuss the risks associated with underage drinking, including alcohol-related disorders. SAMHSA also engages in various efforts to prevent underage drinking.