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 offers food for thought implementing human and animal preventive controls

Phase 2 of the Food Safety Modernization Act (FSMA) implementation, which involves putting in place new public health prevention measures and a risk-based industry accountability framework, was the focus of an FDA public meeting held in Chicago, Illinois on October 20, 2015.

During the meeting, entitled “FDA Food Safety Modernization Act Final Rules on Preventive Controls for Human and Animal Food,” senior FDA officials, state department of agriculture officials, food industry representatives, researchers from educational institutions, and professional association experts combined to provide a basic understanding of:

  • the FSMA preventive controls final rules for both human and animal food;
  • the role of public/private partnerships in the implementation of preventive controls strategies;
  • the FDA’s FSMA implementation efforts to date;
  • the FDA’s FSMA technical assistance network;
  • education, outreach, and training provided through the Food Safety Preventive Controls Alliance; and
  • future regulatory actions.

A transcript of the FDA meeting is available on the FDA’s FSMA website.


FSMA (P.L. 111-353), signed into law on January 4, 2011, amended the federal Food, Drug, and Cosmetic Act (FDC Act) to require the FDA to issue regulations requiring preventive controls for human food and animal food, setting standards for produce safety, and requiring importers to perform certain activities to help ensure that the food they bring into the United States is produced in a manner consistent with U.S. standards.

To comply with FSMA, in 2013, the FDA proposed amendments to its regulations for current good manufacturing practices (CGMPs) in manufacturing, packing, or holding of human food (78 FR 3646, see FDA implements HACCP requirements for facilities registered under the FD&C Act, Health Law Daily, January 16, 2013) and animal food (78 FR 64735, see New standards proposed for pet food makers, Health Law Daily, October 29, 2013).

Then, based on public comments, in September 2014, the FDA issued supplements to the 2013 proposed rules for human food (79 FR 58524, see FDA serves up second proposal for human food manufacturing requirements, Health Law Daily, September 29, 2014) and animal food (79 FR 58476, see FDA takes another proposed bite at manufacturing requirements for animal food, Health Law Daily, September 29, 2014) to make the original proposed rules more practicable, flexible, and effective for industry. At that time, the FDA also reopened the comment period, but only with respect to specific issues identified in the supplemental proposed rules.

On September 17, 2015, the FDA issued its final rules for human food (80 FR 55908, see Food safety rules finally deemed well done (cook time: years), Health Law Daily, September 17, 2015) and animal food (80 FR 56170, see FDA finally finalizes animal food safety rule under FSMA, Health Law Daily, September 17, 2015). The final rules contain elements of both the original and amended proposed rules and new requirements based on public input received during the comment period of both proposals. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms (which are exempt from the regulations) has been significantly changed to reflect modern farming practices.

Preventive controls applying to both human and animal food

Many of the preventive controls regulations for human and animal food are identical. According to the FDA officials, these key joint requirements include:

  • Establishment and implementation of a food safety system that includes an analysis of hazards and risk-based preventive controls. The rules set requirements for a written food safety plan that includes hazard analysis, preventive controls, and oversight and management of preventive controls. The oversight and management functions must include appropriate monitoring, corrections and corrective actions, and verification.
  • Operations defined as ‘farms’ are not subject to the preventive controls rule. The rules clarify that the definition of a ‘farm’ covers two types of farm operations: (1) a primary production farm, and (2) a secondary activities farm. The primary production farm is an operation under one management in one general, but not necessarily contiguous location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The secondary activities farm must be majority-owned by the primary production farm and consists of an operation not located on the primary production farm that is devoted to harvesting, packing and/or holding raw agricultural commodities.
  • A more flexible supply-chain program. The rules mandate that a manufacturing/processing facility must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply chain applied control. Manufacturing/processing facilities that control a hazard using preventive controls, or who follow requirements applicable when relying on a customer to controls hazards, do not need to have a supply-chain program for that hazard.

CGMPs for human food

The human food rule updates the human food CGMPs to make certain previously nonbinding provisions, such as education and training, binding. For example, management now is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. As such, employees must have the necessary combination of education, training, and/or experience needed to manufacture, process, pack, or hold clean and safe food. In addition, the FDA’s longstanding position that CGMPs address allergen cross-contact is now explicit in the regulatory text.

CGMPs for animal food

The animal food rule updates the animal food CGMPs by finalizing baseline standards for producing safe animal food. For animal food processors already implementing human food safety requirements, they do not need to implement additional preventive controls or CGMP regulations when supplying a by-product for animal food, except to prevent physical and chemical contamination when holding and distributing the by-product. Further processing a by-product for use as animal food requires companies to process the by-product to ensure the animal food’s safety and to make sure that the processing does not introduce hazards to the animal food.

Vertically integrated feed mills

Under the animal food rule, feed mills associated with fully, vertically integrated farming operations (i.e., farms where the feed mill, animals, land, and establishment are all owned by the same entity) generally meet the definition of a farm and are therefore not subject to the animal food rule. FDA officials, however, remain concerned that not having these operations subject to the preventive controls for animal food leaves a protection gap because these feed mill operations manufacture significant amounts of animal food. As such, the FDA stated that it intends to publish a future proposed rule that would require some feed mill operations that currently are part of a farm to implement the CGMPs established by the animal food rule.

Implementation update

After the overview of the preventive control and CGMPs requirements, the FDA officials gave an update on FSMA implementation. Their update described the promulgation of the human and animal food final rules as Phase 1 of FSMA implementation; gaining, maintaining, and overseeing industry compliance with the rules as Phase 2; and monitoring, evaluating, and refreshing transition strategies and performance metrics from design to operational to evaluate success as Phase 3. Phase 2, the current focus, involves the facilitation of industry compliance through guidance, industry alliances, and technical assistance networks.

Q&A sessions

During the question & answer (Q&A) sessions of the meeting, numerous inquiries focused on the individual concerns of specific stakeholders. While FDA officials were able to answer most of these questions by pointing to either specific language in the new regulations or in the preambles to the final rules, it was apparent that the answers to some questions would have to wait for additional guidance from the FDA. One major concern of stakeholders was what to do in the situation where an FDA inspector makes a finding that is contrary to previous FDA guidance or an earlier inspection. While FDA officials did not answer this question directly, it was perhaps answered implicitly by their promise that FDA inspectors will be subject to rigorous training on FSMA implementation.

Industry guidance

The FDA officials indicated that the agency is also committed to educating the industry on the requirements of the human and animal food rules. To that end, the officials stated that the FDA is currently developing guidance that will cover the following topics: (1) animal food CGMP requirements; (2) hazard analysis and preventive controls for human and animal food; (3) human food by-products for use as animal food; (4) human food environmental monitoring; (5) human food allergen controls; (6) validation of process controls for human food; and (7) a small entity compliance guide for human and animal food.

From the private sector, Daisuke Ito, Director of Agriculture and Research at Japan External Trade Organization (JETRO) in Chicago, Illinois offered the assistance of JETRO to the FDA in preparing guidance for international stakeholders. Tim Jackson, Director of Food Safety, Nestle USA, Nestle Canada, and Nestle Professional North America, spoke on behalf of the members of the Grocery Manufacturers Association (GMA). Jackson indicated that GMA desires to move toward a better, systems-based, inspection process, rather than simply a checklist. In addition, he offered GMA assistance in educating FDA inspectors on the latest food production technology.

Training and technical assistance

Plans for training and technical assistance are also underway for the industry and inspectors, according to the FDA officials. For industry, they include: (1) establishing a Food Safety Technical Assistance Network within the FDA to provide a central source of information to support industry understanding and implementation of FSMA; (2) collaborating with the Illinois Institute of Technology’s Institute for Food Safety and Health, a nationally-recognized leader in food safety, in the creation of a Food Safety Preventive Controls Alliance (FSPCA) designed to establish training and technical assistance programs; and (3) partnering with the National Institute of Food and Agriculture in the U.S. Department of Agriculture to administer a grant program to provide technical assistance to small and mid-size farms and small food processors.

Robert Brackett, Vice President and Director, Illinois Institute of Technology’s Institute for Food Safety and Health, spoke about the development of the FSPCA. He described FSPCA as a public/private alliance made up of key industry, academic, and government stakeholders who are working to support safe food production through the development of a nationwide core curriculum, with training and outreach programs to assist domestic and international companies producing human and animal food in complying with the FSMA preventive controls regulations. He also spoke of the need for qualified individuals in industry to apply to become FSPCA instructors.

To ask a question to the FDA regarding FSMA Technical Assistance Network, stakeholders were told by FDA officials to go to: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm and click on “Submit Inquiry.”

Future FDA regulatory actions

The FDA officials also made note of additional FSMA final rules that are pending. Three of these rules are expected to be finalized by October 31, 2015. They are: (1) the Produce Safety Rule; (2) the Foreign Supplier Verification Program Rule; and (3) the Accreditation of Third-Party Auditors Rule.

Two other important rules are: (1) the Sanitary Transportation of Human and Animal Food Rule – expected to be finalized by March 31, 2016; and (2) the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Rule – expected to be finalized by May 31, 2016.

FTC offers Third Circuit a primer on how to properly evaluate ‘product hopping’

 The Federal Trade Commission (FTC) filed an amicus brief with the U.S. Court of Appeals for the Third Circuit explaining that the U.S. District Court for the Eastern District of Pennsylvania “made significant analytical errors” in granting summary judgment to brand-name drug manufacturer, Warner Chilcott PLC, in a dispute with generic competitor, Mylan Pharmaceuticals, Inc., involving allegations that Warner Chilcott unlawfully suppressed generic competition and maintained its monopoly power through a strategy called “product hopping.”

In its brief, the FTC takes no position on the ultimate merits of the lawsuit, but claims that in examining whether “product hopping” is unlawful, the district court erroneously expressed a “broad-brush opposition to product-hopping liability in any circumstances” and failed to account for the unique aspects of the pharmaceutical marketplace, including the nature of competition between brand name drugs and their generic equivalents. The FTC argues that the Third Circuit should remand the case to the district court with instructions to apply the antitrust principles discussed in its brief.

Typical “product-hopping” scheme defined

A typical product-hopping scheme may arise when generic rivals are expected to win FDA approval to compete with a company’s profitable brand-name drug using automatically substitutable equivalents. First, the brand-name company introduces minor changes to the drug’s formulation, such as therapeutically insignificant tweaks to dosage levels or to the form of administration (such as capsules vs. tablets). Second, before generic equivalents have a chance to enter the market, the brand-name manufacturer takes various steps to extinguish demand for the original version. For example, the manufacturer might restrict or eliminate the supply of the original formulation, increase its effective price to patients, or flood physician offices with free samples of the revised formulation to divert prescriptions to the revised formulation.

In addition, because automatic pharmacy substitution ordinarily requires an FDA determination of therapeutic equivalence—an “AB rating,” and because an AB rating is specific to dosage and form, a pharmacist cannot automatically substitute a generic drug that differs even slightly from the dosage or form of the prescribed brand-name drug. The generic entrant is thereby faced with trying to make conforming changes to its own product, which it cannot sell without starting a new FDA approval process. Therefore, according to the FTC, “the brand-name manufacturer’s well-timed tweaks to its drugs can create an ever-retreating horizon of generic competition at the expense of consumers.”


The alleged product-hopping scheme in this case involves delayed-release doxycycline hyclate, a prescription drug used primarily to treat severe acne. Warner Chilcott markets a brand-name form of the drug sold under the name Doryx. Mylan alleges that, before generic entry, Warner Chilcott engaged in anticompetitive product-hopping by curtailing the availability of the original formulation in order to shift the market to three successive product reformulations that offered little or no therapeutic benefit to consumers. Mylan claims that this conduct impeded meaningful generic competition and preserved Warner Chilcott’s monopoly profits, not because the market valued the reformulations on the merits, but because Warner Chilcott had successfully manipulated the pharmaceutical regulatory system.

District court ruling

To prove unlawful monopolization under Section 2 of the Sherman Act, Mylan must prove two elements: (1) the possession of monopoly power by Warner Chilcott in the relevant market; and (2) its willful acquisition or maintenance of that power through anticompetitive means, as distinct from competition on the merits.

In granting summary judgment to Warner Chilcott, the district court concluded that no reasonable juror could find, based on “uncontradicted evidence” of “the interchangeability of Doryx with other oral tetracyclines,” that Warner Chilcott had monopoly power. The court also concluded that, even if Warner Chilcott had monopoly power, the product-hopping scheme would not have violated the Sherman Act.

In making its ruling, the district court accepted Mylan’s claims that Warner Chilcott “made the Doryx ‘hops’ . . . primarily to defeat generic competition” and that the hops “prevented Mylan from taking advantage of more profitable means of distributing its generic Doryx.” Nevertheless, the district court held that Mylan could have competed against Warner Chilcott through means other than automatic substitution and faulted Mylan for not promoting its generic versions of Doryx through advertising and marketing. The court also characterized automatic substitution as a “regulatory windfall” to generic manufacturers and concluded that Warner Chilcott’s efforts to deny Mylan the benefits of that mere “windfall” were “hardly predatory.”

Mylan appealed the district court’s ruling to the Third Circuit.

FTC arguments

In its brief, the FTC first argues that in deciding that Warner Chilcott did not possess monopoly power the district court erred by ignoring the unique characteristics of the pharmaceutical market. Monopoly power, under previous court decisions, may be established through direct evidence, such as prices substantially above the competitive level, or indirect evidence, such as a large share of a relevant market subject to entry barriers. In addition, the U.S. Supreme Court has stated that antitrust inquiries must be attuned to the particular structure and circumstances of the industry at issue.

Therefore, according to the FTC, the district court was mistaken when, in denying monopoly power, it found a broader market here on the basis of outward evidence that many dermatologists view other oral tetracyclines as therapeutically interchangeable with Doryx. The functional interchangeability between products, however, is the beginning, not the end of the analysis, according to the FTC. The FTC believes that the district court’s monopoly-power analysis needs to go farther and ask whether the prospect of substitution is strong enough to keep prices at competitive levels. The FTC bases this argument on evidence that price competition from other interchangeable drugs “is often so attenuated in the absence of automatic substitution that brand-name manufacturers can maintain prices substantially above the competitive level, the key criterion for monopoly power.”

The FTC also argues that the district court erred in granting summary judgment on the alternative ground that, even if Warner Chilcott had monopoly power, its product hopping did not constitute the willful maintenance of the power through anticompetitive means. The FTC believes that the district court’s reasoning reflects a misunderstanding of how competition works in the drug industry and, in effect, “embraces a rule of nearly per se legality for product-hopping conduct by brand-name manufacturers. This approach, the FTC argues, contradicts the decisions several courts.

For example, on May 22, 2015, the Second Circuit in New York v. Actavis PLC, 787 F.3d at 655, decided that a pharmaceutical manufacturer can violate Section 2 of the Sherman Act if it uses a product-hopping scheme to foreclose rival generic manufacturers from their most efficient distribution channel: automatic substitution at the pharmacy for AB-rated drugs. In that case, the brand-name manufacturer altered the formula for an anti-Alzheimer’s drug to avoid automatic generic substitution, and it took various steps, including sharply limiting supply of the original version, to ensure that most physicians would prescribe only the reformulated version before the expected date of generic entry. The Second Circuit concluded that because the brand-name manufacturer’s product switch was accomplished through something other than competition on the merits, and it had the effect of significantly reducing usage of generic products and protecting its own monopoly, it was anticompetitive.

Finally, the FTC addressed the fact that the district court seemed to accept innovation as a basis for rejecting product-hopping in any context, no matter how trivial the revised formulation may be and no matter how aggressively the brand-name manufacturer shifts the market to the revised formulation prior to facing generic competition on the original formulation. According to the FTC, the district court’s position on innovation contradicts established antitrust doctrine, which states that judicial deference to product innovation does not mean that a monopolist’s product design decisions are per se lawful.

The FTC notes that genuine innovation is unlikely to be chilled simply because the antitrust laws may hold brand-name manufacturers liable for minor product tweaks that have little or no therapeutic value and serve only to avoid generic competition. The FTC also believes that a brand-name manufacturer is unlikely to face potential antitrust liability if it does not take steps to damage the market for the original formulation and instead allows the marketplace to choose between the original formulation and the revised version.

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.”