Court imposes 10-month deadline for pre-market tobacco applications

A federal district court in Maryland has set a deadline of 10 months for tobacco product manufacturers to submit pre-market applications and a one year deadline for FDA approval. The court previously concluded that the FDA violated the Administrative Procedure Act (APA) when it released guidance in 2017 extending the compliance deadline for the “Deeming Rule” which brought new tobacco products under the purview of the Family Smoking Prevention and Tobacco Control Act. Rather than remanding the issue to the FDA to determine a timeline for compliance or accepting the plaintiffs’ request of a four-month deadline for applications, the court accepted the FDA’s recommendation of a 10-month deadline. The court found that it has the authority to impose such a deadline under the extraordinary circumstances of the case, in which prompt action is necessary to combat the public health crisis caused by the rise in youth e-cigarette use (American Academy of Pediatrics v. FDA, July 12, 2019, Grimm, P.).

FDA tobacco rule compliance extensions

On May 10, 2016, the FDA issued the “Deeming Rule,” bringing approximately 25,000 new tobacco products, including various cigars, e-cigarettes, pipe tobacco products, and hookah within the purview of the Family Smoking Prevention and Tobacco Control Act. The Deeming Rule went into effect 90 days after its publication (see FDA clears the air, ‘deems’ e-cigarettes, hookah tobacco, cigars worthy of regulation, Health Law Daily, May 10, 2016). In May 2017, the FDA extended the compliance deadline by three months. In August 2017, the FDA extended the timelines to submit tobacco product review applications for deemed tobacco products that were on the market as of August 2016. In May 2019, the district court ruled that the FDA’s August 2017 compliance deadline extension violated the Administrative Procedure Act, as it was done without following notice and comment requirements. The court vacated the August 2017 Guidance and asked the parties to brief the court on potential remedies, given that the application deadlines in the Deeming Rule and May 2017 Guidance had passed.

Remedy

The court concluded that the case presented “extraordinary circumstances” that called for more than simply vacating the guidance and remanding the issue to the FDA (as was requested by manufacturers). It imposed a 10-month deadline for submissions and a one-year deadline for approvals, as suggested by the FDA. The plaintiffs had requested a four-month deadline for submissions, but the court rejected that solution because of the record from the FDA demonstrating that a four-month deadline would prevent them from timely approving or denying applications and could clear the market of e-cigarette products, thus creating a risk that adult smokers would switch from e-cigarettes to combustible tobacco products. The FDA also presented evidence that it plans to accelerate the premarket review requirements for the products that are most attractive to youth, such as flavored products.

The court concluded that without a deadline for filing, manufacturers would be unlikely to move forward with applications, because the record showed a purposeful avoidance by the industry of complying with the premarket requirements despite entreaties from the FDA that it can do so, and it establishes a shockingly low rate of filings.

FDA fights ‘dishonest actors’ to preserve clinical potential of stem cell research

The FDA is increasing its stem cell therapy enforcement activity to diminish the influence of “unscrupulous actors” while protecting the promise of responsible stem cell therapy innovations. According to FDA Commissioner Scott Gottlieb, the agency plans to release a new comprehensive policy framework in the fall of 2017 to properly describe the rules governing the new field of regenerative stem cell research and product development. The framework will provide a more efficient means for stem cell product developers to gain FDA approval.

Enforcement

The announcement of stepped up enforcement activities follows a warning letter issued by the FDA on August 24, 2017 to US Stem Cell Clinic of Sunrise, Florida, due to the manufacturers “significant deviations from current good manufacturing practice requirements” and the seizure, on August 25, 2017, of an unapproved vaccine, which the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California were using to create an unapproved stem cell product for cancer patients. The warning letter followed an investigation which revealed the clinic failed to develop appropriate procedures to prevent microbiological contamination. The seizure of the vaccine followed an inspection which revealed the vaccine was used to create an intravenous stem cell cancer product with unproven efficacy and risks of serious health problems related to using the virus.

Guidance

In response to the recent enforcement measures, the FDA launched a new working group focused on pursuing similar, “unscrupulous clinics.” The new framework develops a bright line to accommodate what Gottlieb called “good actors working on genuine science.” The FDA plans to set out the policy in a series of guidance documents.

FDA issues warning statements for cigars, guidance on warning plans

Although the FDA took five years from the passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Act) (P.L. 111-31) to extend its regulatory authority to cover cigars, it has now issued guidance on required warning statements for cigar products. By May 10, 2018, cigars may not be manufactured, packaged, sold, offered for sale, or imported for sale or distribution without one of several warning statements appearing on product packaging. Manufacturers may not distribute products in non-compliant packaging beginning June 11, 2018.

Final rule and new regulations

The Tobacco Act, enacted June 22, 2009, granted the FDA the authority to deem statutorily defined tobacco products as subject to the agency’s regulation. The FDA did so through a Final rule (81 FR 28974), which established the FDA’s authority over any product made or derived from tobacco and intended for human consumption. These regulations establish responsibilities of manufacturers, distributors, and retailers, which include proper presentation of warning statements and the submission of warning plans (21 C.F.R. parts 1100-1143).

Required statements

As of the effective date, all cigar packages and advertisements must contain one of the following statements:

  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  • 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: Cigar use while pregnant can harm you and your baby.
    or
  • SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

Although retailers are subject to the regulations, they will not be considered in violation of these requirements if the cigars offered for sale contain a health warning, are supplied from a source that has the required licenses or permits, and are not altered by the retailer in a meaningful way. Individually sold cigars without packaging are exempt from packaging requirements, but retailers must post a warning sign with all six warning statements at the point of sale.

Warning plans

The requirement to submit warning plans to the FDA for cigars will take effect May 10, 2017. These plans must provide that all warning statements are displayed in each 12-month period, on each product brand, and are randomly displayed as equally as possible and randomly distributed in all areas of the US.

Generally, for packaged cigars, the FDA believes that the brand manufacturer is best able to ensure that the warning plan contains sufficient information for approval and that the packaging complies with the requirements. If a product is manufactured under contract, the contracting entity is best suited to submit the plan. Importers of finished cigars usually control packaging and distribution, and should submit the plan. Usually, retailers should not submit warning plans, unless they are responsible for the placement of warning statements.

FDA’s line of ‘thinking’ via draft guidances draws lawmakers’ attention

Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, including Senator Lamar Alexander (R-Tenn), asked the FDA to explain why draft guidances were not being revised, finalized, or withdrawn in a timely manner. In a letter expressing concern on the matter, the lawmakers asked the FDA to update information and provide answers to questions regarding (1) the length of time it took for each FDA center to finalize a draft guidance, previously reported as between 425 and 797 days; (2) the number of still-pending draft guidances published prior to December 31, 2013, previously reported as standing at 172; (3) current work plans to address draft guidance review; and (4) FDA staff training on the use of draft guidances in the absence of a final guidance document.

Although the senators applauded the implementation of easy-to-use navigation of guidance documents on the FDA website, the lawmakers stressed that it should be kept as up to date as possible. In the previous 12 months, the FDA took action to withdraw 47 guidance documents that it considered “outdated and unfinished.”

However, the lawmakers noted that industry members, including physicians and corporations, were concerned about the agency’s reliance on draft guidances to carry out regulatory responsibilities. As such, industry felt compelled to follow the draft guidances as if final, even if the most up-to-date information suggested an alternative path. The lawmakers noted that the FDA was periodically sending, as well as publicizing, “It has come to our attention” letters that relied upon new “thinking” only previously discussed in a draft guidance to raise concerns about a current regulated product.