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FDA (Food and Drug Administration) Proposes Tobacco Products Rule; E-Cigarettes, Cigars To Be Regulated

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The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register and list products the with Agency and submit new products for premarket review.

On April 25, the U.S. Food and Drug Administration (FDA or the Agency) published a proposed rule (the Rule) in the Federal Register, establishing, for the first time, federal regulatory authority over electronic cigarettes (e-cigarettes), cigars, pipe tobacco, dissolvable tobacco products, and nicotine gels (deemed tobacco products).[1]

Key Takeaways from the Rule, if Finalized

The following would apply to the newly deemed tobacco products:

  • No sales to those younger than 18 years of age and requirements for verification by means of photographic identification
  • Requirements to include health warnings on product packages and in advertisements
  • Prohibition of vending machine sales unless in an adult-only facility

In addition, per the Rule, manufacturers of newly deemed tobacco products would be subject to the following requirements, among others:

  • Register with, and report product and ingredient listings to, the Agency
  • Market new tobacco products only after FDA review
  • Not make direct and implied claims of reduced risk unless FDA confirms (1) that scientific evidence supports the claim and (2) that marketing the product will benefit public health
  • Not distribute free samples

Background

The Tobacco Control Act provides FDA with the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products not named in the tobacco control statute (e.g., e-cigarettes) to be subject to the FD&C Act. Section 906(d) provides FDA with the authority to propose restrictions on the sale and distribution of tobacco products, including restrictions on access to, and advertising and promotion of, tobacco products if FDA determines that such regulation would protect public health.

The Rule would extend FDA’s existing authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to include e-cigarettes, cigars, pipe tobacco (including hookah [water pipe] tobacco), dissolvable tobacco products, and nicotine gels. This latter group of tobacco products, deemed by FDA to be subject to the Tobacco Control Act, was not named in such legislation.

Scope of the Rule

Broadly, the Agency has proposed the following two alternatives for the scope of the deeming provisions and, consequently, the application of the Rule:

  • Option 1 would extend the Agency’s authority to all tobacco products not previously regulated by FDA that meet the statutory definition of “tobacco product,”[2] except accessories of such products
  • Option 2 would extend the Agency’s authority to all tobacco products not previously regulated by FDA that meet the statutory definition of “tobacco product,” except premium cigars[3] and the accessories of products not previously regulated by FDA

FDA is seeking comment on the relative merits of Option 1 versus Option 2, based primarily on the public health consequences of adopting one option or the other.

The principal difference between the two options is the scope of cigar regulation. Under Option 1, all cigars would be covered. Under Option 2, only a subset of cigars (i.e., “everything but “premium” cigars) would be covered by the Rule.

As noted above, accessories of proposed deemed tobacco products are outside the scope of the Rule. FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or items that are intended or expected to be used by consumers in the consumption of a tobacco product. For example, FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product (e.g., hookah tongs, bags, cases, charcoal burners and holders, cigar foil cutters, humidors, carriers, and lighters). However, e-cigarettes, and the components thereof, and hookah pipes are covered by the Rule.

Requirements; Implications for Retailers and Manufacturers

Generally, deemed tobacco products would be subject to the same FD&C Act provisions that apply to cigarettes. These include, but are not limited to the following:

  • Prohibition on selling (at a retail counter or via a vending machine) these products to persons under 18 years of age and verification by means of photographic identification related to the same
  • Enforcement action against products determined to be adulterated and misbranded
  • Required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products
  • Required registration and product listing for all tobacco products
  • Prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use
  • Prohibition on the distribution of free samples
  • Premarket review requirements

Display of Health Warnings on Deemed Tobacco Product Packages and Advertisements

The Rule would require the following health warning on packages of cigarette tobacco, roll-your-own tobacco, and deemed tobacco products other than cigars sold, distributed, or imported for sale within the United States: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” Regarding cigars, the Rule would require that any cigar sold, distributed, or imported for sale within the United States must bear one of the following warning statements on each product package:

  • “WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.”
  • “WARNING: Cigar smoking can cause lung cancer and heart disease.”
  • “WARNING: Cigars are not a safe alternative to cigarettes.”
  • “WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.”
  • “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”[4]

These warning statement requirements also apply to advertisements of cigarette tobacco, roll-your own tobacco, and deemed tobacco products, regardless of form, which could encompass retail or point-of-sale displays (including functional items, such as clocks or change mats), magazine and newspaper ads, pamphlets, leaflets, brochures, coupons, catalogues, posters, billboards, direct mailers, and Internet advertising (e.g., websites, banner ads, etc.).

New Requirements for Deemed Tobacco Products; Implications for E-Cigarettes and Hookahs

Significantly, the Rule would require manufacturers of deemed tobacco products to meet new additional requirements. In addition to the deemed tobacco products themselves, the scope of the Rule also includes components and parts sold separately or as parts of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include, but are not limited to, the following:

  • Air/smoke filters
  • Tubes
  • Papers
  • Pouches
  • Flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers)
  • Cartridges for e-cigarettes (including the liquid contained therein)

The Rule would require manufacturers of deemed tobacco products that were not on the market in the United States by February 15, 2007 to only market such products after FDA premarket clearance. The review process adopts a system similar to the medical device regulatory process. Manufacturers may submit either (1) a premarket tobacco product application (PMTA) to, and receive a marketing authorization order from, FDA or (2) a substantial equivalence (SE) report if the new product is substantially equivalent to a predicate product (i.e., a product commercially marketed in the United States as of February 15, 2007) at least 90 days prior to introducing or delivering for introduction into interstate commerce for commercial distribution of the product.[5]

A PMTA may require one or more types of studies, including chemical analysis, nonclinical studies, and clinical studies. To demonstrate substantial equivalence, an SE notice must compare a new product to a predicate product to demonstrate that the products have the same characteristics or, if there are differences between such products, that the differences do not raise different questions of public health.

The Agency intends to continue to allow the marketing of such products pending FDA’s review of either a PMTA or SE notice, presuming such application or notice is submitted within 24 months after publication of the final Rule. It is unclear whether most e-cigarette products commercially marketed in the United States could be eligible for an SE report or if they would be required to go through the PMTA process.

Although the PMTA and SE requirements do not take effect until 24 months after publication of the final Rule, we would expect manufacturers to begin, in the near term, to gather the necessary information and prepare the necessary applications/notifications to come into compliance. Those manufacturers that submit their PMTAs or SE reports early within the 24-month window presumably will receive clearance before the close of the window. Retailers should be aware of supply chain issues and possible disruptions in the marketplace because of the Rule and should work with suppliers to understand the continued availability of deemed tobacco products.

What Is Not in the Rule; No Impact on Internet Sales or Flavored Products

The Rule’s prohibition on sales from vending machines is not intended to impact the sale of any tobacco product via the Internet, and the Rule does not otherwise address Internet sales. Note, however, that state laws would continue to apply to Internet sales.

Moreover, the Rule does not restrict the sale of deemed tobacco products that are flavored. FDA specifically notes in the Rule that the prohibition against the use of characterizing flavors established in the Tobacco Control Act applies to cigarettes only (i.e., it does not apply to e-cigarettes, pipe tobacco, cigars, dissolvable tobacco products, or nicotine gels). However, FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a “cigarette” as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors. FDA’s request for comments in this area is in response to the proliferation of products marketed as “little cigars” or “cigarillos” (allegedly to get around the flavored cigarette ban), but which the Agency has indicated are truly cigarettes.

Compliance Dates

The age restrictions in the Rule would take effect 30 days after publication of the final Rule, whereas the proposed health warning requirements would take effect 24 months after publication of the same. The PMTA and SE requirements would also take effect 24 months after publication of the final Rule.

Comments on the Rule

Interested parties are encouraged to submit comments on the Rule, identified by Docket No. FDA-2014-N-0189 and/or Regulatory Information Number (RIN) 0910-AG38 by July 9, 2014.

[1]. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 79 Fed. Reg. 23,142 (proposed April 25, 2014) (to be codified at 21 C.F.R. pts. 1100, 1140, 1143), available here.

[2]. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” FDA notes in the Rule that products falling within the FD&C Act’s definition of “tobacco product” may not be considered tobacco products for federal excise tax purposes. See 26 U.S.C. § 5702(c).

[3]. The Rule defines “premium cigars” as cigars that are wrapped in whole tobacco leaf; contain a 100% leaf tobacco binder; contain primarily long filler tobacco; are made by manually combining the wrapper, filler, and binder; have no filter, tip, or non-tobacco mouthpiece and are capped by hand; do not have a characterizing flavor other than tobacco; weigh more than 6 pounds per 1,000 units; and sell for $10 or more per cigar.

[4]. In 2000, in settlements with the Federal Trade Commission (FTC), the seven largest U.S. cigar manufacturers agreed to include warnings about significant adverse health risks of cigar use in their advertising and packaging. See, e.g., In re Swisher International, Inc., Docket No. C-3964 (FTC Aug. 25, 2000). Under the 2000 FTC consent orders, virtually every cigar package and advertisement is required to clearly and conspicuously display one of several warnings on a rotating basis. FDA is proposing to adopt these four cigar warning statements from the FTC consent orders, which the vast majority of cigars already use.

[5]. FDA states in the Rule that it is aware of new product category entrants into the market after the February 15, 2007 reference date and that the SE pathway may not be available to these newer products.

Article By:

Jonathan A. Havens
Anthony “Tony” Pavel
Kathleen M. Sanzo
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Morgan, Lewis & Bockius LLP

FDA (Food and Drug Adminsitration) Releases Final Electronic Medical Device Reporting (eMDR) Rule and Deadline for Compliance

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The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has been identified. The rule impacts device manufacturers and importers and mandates electronic submission of individual medical device adverse event reports. User facilities may continue to submit only written reports.

As of August 14, 2015, postmarket medical device adverse event reports by manufacturers and importers must be submitted only electronically to the FDA’s Center for Devices and Radiological Health via the Electronic Submissions Gateway (ESG). The ESG is used for all forms of electronic filing to the FDA; information specific to medical device submissions is available here. Guidance about the eMDR is available here.

It is recommended you review your current system for submitting reports, and if you are not already utilizing the ESG for all reporting, develop a plan now for integrating the electronic process into your operations.

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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

FDA (Food and Drug Administration) Declines Courts’ Requests to Define “Natural” with respect to GMO (Genetically-Modified Organisms) Foods

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The FDA recently issued a letter to three federal district court judges declining the courts’ requests to adopt a definition of “natural” or to state whether the terms “natural” or “all natural” can be used to refer to foods containing genetically-modified organisms (GMOs) to help resolve pending consumer class actions over the term. The FDA cited three reasons for its decision not to define the term(s): (1) it would prefer to use a public, administrative process than to define the term in the context of private litigation; (2) the definition implicates other agencies, most notably, the USDA; and, (3) the FDA has limited resources and other matters currently take priority.

As noted in our August 2013 Alert on the issue, Judge Yvonne Gonzalez Rogers of theNorthern District of California started the trend in Cox v. Gruma Corp., a case in which the plaintiff alleges that Gruma’s use of “all natural” on its tortilla shells violates various consumer protection laws because they contain genetically-modified corn. In Van Atta v. General Mills, pending in Colorado and involving GMOs in granola products, a magistrate judge agreed with Judge Rogers and recommended a stay of proceedings in the case pending the FDA’s response to Judge Rogers’s request. Most recently, in Barnes v. Campbell Soup Co., also pending in the Northern District of California and involving GMOs in various soups, a different judge also stayed the case pending the FDA’s response.

These cases are potentially quite important because there are many pending consumer class actions, particularly in California, over whether the use of some variant of the term “all natural” is proper in light of one or more ingredients in the food at issue. Indeed, some quip that food labeling litigation has replaced tobacco and asbestos as the favorite category of suit for the plaintiffs’ bar. Thus, the FDA’s response to the request by these courts, and the courts’ further actions based on the response, could resolve or guide the resolution of many of these cases.

In a related development, the Grocery Manufacturers’ Association has recently filed a citizen’s petition asking FDA to state that GMO foods may be labeled “natural.” The FDA alluded to the possible filing of this petition in its letter, but did not state whether it is willing to take up the issue using that procedure, which does allow for public comment.

A copy of the FDA’s letter can be found here.

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Barnes & Thornburg LLP

A Short-Lived Victory for Generic Drug Manufacturers?

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On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where federal law prohibits an action required by state law. The Supreme Court had previously held in Pliva v. Mensing, 564 U.S. ____ (2011) that failure to warn claims against generic drug manufacturers are pre-empted by the Federal Food Drug and Cosmetic Act since generic drug makers must copy innovator drug labeling precisely in order to obtain approval of their products by the U.S. Food and Drug Administration (“FDA”). The Court in Mutual rejected the argument of lower courts that the generic manufacturer could comply with both federal and state law by choosing not to make and distribute the product at all.

The case in question involved the drug sulindac, a non-steroidal anti-inflammatory drug product marketed by the innovator as Clinoril®. The plaintiff in the case had been prescribed sulindac for treatment of shoulder pain. She subsequently developed a case of toxic epidermal necrolysis following taking an FDA approved generic product equivalent to Clinoril®, which resulted in significant and permanent disability (including blindness) and disfigurement. Subsequent to the event, the FDA required a more specific warning as to this possible side effect on sulindac products. A jury found the generic manufacturer liable under a theory that there was a design defect with the product, and the First Circuit affirmed, holding that the generic manufacturer could have complied with both federal and state law by not manufacturing and distributing the product. This was the method by which the lower courts overcame prior precedent that a state law may be impliedly pre-empted when it is not possible to comply with both federal and state law.

The Supreme Court in Mutual noted that the generic manufacturer could not comply with the state law, since federal law requires that the active ingredient, the amount of the active ingredient, the dosage form, and the labeling had to be identical to the innovator product. In this case, it was not possible to redesign the product, and the only way, under New Hampshire law, to remedy the design defect would have been to strengthen the product’s warnings. That too could not be done, as FDA rules require the labeling of the generic to be identical to that of the innovator. The Court ruled that in such a case the state law is without effect, and relevant New Hampshire warning-based design defect cause of action was pre-empted with respect to FDA-approved generic drugs sold in interstate commerce.

The scope of the Mutual decision may be limited to those states where design-defect claims allow for a risk-utility approach such as that the New Hampshire requires. The New Hampshire standard requires, among other things in determining whether there is a valid cause of action for a design defect, a determination as to whether there is a possible warning to avoid unreasonable risk of harm from the design defect and the efficacy of such warning. So not every design-defect claim may be pre-empted, depending on each state’s laws are interpreted. But given the Court’s reasoning, even state laws that do not take into effect the presence of and efficacy of a warning, may be pre-empted, as the generic must copy the formula of the innovator in all respects, except for the inactive ingredients in the product. (It should be noted that generics of some dosage forms – ophthalmic products and injectable products – must, in most cases, contain the same inactive ingredients as in the innovator product in the same amounts).

Furthermore, the FDA may amend its rules to permit ANDA holders to make changes in labeling. See “FDA Rule Could Open Generic Drug Makers to Suits,” The New York Times, Business, July 4, 2013, at B2. As stated in the posting on the OMB website (RIN 0910-A694):

Abstract: This proposed rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change. The proposed rule would describe the process by which information regarding a “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA’s review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder’s CBE labeling supplement. These proposed revisions to FDA’s regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.

The expected date for a Notice of Proposed Rulemaking is September 2013. It could, of course, take FDA quite some time to propose a rule, and put it into effect, given the requirements of the Administrative Procedure Act. And Congressional action is also a possibility.

For the present, however, generic drug manufacturers appear to be shielded from liability under the doctrine of pre-emption from most, if not all, failure to warn and design defect claims under state law. Whether that victory is short-lived or not remains to be seen.

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FDA Discloses Method for Classifying Food Facilities as "High Risk" Under FSMA

The National Law Review published an article regarding FDA High Risk Food Facilities Classification Methods written by Lynn C. Tyler, M.S., Nicolette R. Hudson and Hae Park-Suk of Barnes & Thornburg LLP:

The Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, requires FDA to inspect food facilities on different time tables depending on whether a facility is classified as “high risk” or not. High-risk facilities must be inspected at least once within the first five years after the enactment of the FSMA and once every three years thereafter. Non-high risk facilities must be inspected at least once within the first seven years after the enactment of the FSMA and once every five years thereafter.

The U.S. Food and Drug Administration (FDA) recently disclosed the method it intends to follow to classify food facilities as high risk or non-high risk under the FSMA. The agency first noted that the FSMA set forth six risk factors to be considered in making this determination:

  • The known safety risks of the food manufactured, processed, packed or held at the facility
  • The compliance history of the facility
  • The facility’s hazard analysis and risk-based preventive controls (HARBPC)
  • Whether the food at the facility meets the criteria for priority to detect intentional adulteration in imported food
  • Whether the food at the facility has received certain certifications
  • Other criteria identified by Health and Human Services

FDA then noted that for FY 2011-13 the classification decision will be based primarily on the first two factors and according to the following algorithms:

  • If a facility manufactures food categories associated with foodborne outbreaks AND class I recalls (reasonable probability of serious adverse health consequences or death), it is high risk
  • If a facility manufactures food categories associated with foodborne outbreaks OR class I recalls AND it has not been inspected within the last five years, it is high risk
  • Facilities with a checkered compliance history (three or more inspections resulting in Voluntary Action Indicated findings or one or more resulting in Official Action Indicated findings within the last five years) are high risk

FDA stated that it plans to modify and adjust these criteria in the future as it develops data on some of the FSMA criteria and for other reasons. It also reserved the right to inspect a facility more frequently when necessary in its judgment.

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