FDA Deeming Regulations

FDA Delays Enforcement of All Future Compliance Deadlines

FDA Guidance: “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule

The U.S. Food and Drug Administration (FDA) recently announced their intention to defer enforcement of all future compliance deadlines under the deeming regulations which became effective last year. The agency indicates that in light of the lawsuits stemming from the final rule issued last year extending the FDA authority to additional tobacco products, including e-cigarettes, they will extend the deadlines for compliance by three extra months. The agency will be issuing guidance outlining this new position soon.

In the meantime, the below is the announcement issued this week by the FDA:

“The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.

This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.

This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.

This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.”

Cole and Bishop Introduce The FDA Deeming Authority Clarification Act of 2017

Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA) introduced legislation in the House of Representatives – HR 1136 – to change the predicate date for newly “deemed” tobacco products, impose common-sense licensing and advertising guidelines for vapor products and direct the FDA to establish product standards for vapor product batteries.

This legislation would make a much-needed correction in the Tobacco Control Act which currently uses Feb. 15, 2007 as the predicate date, making it much harder for vapor products to come to market than cigarettes despite studies showing vapor is less harmful than combustible tobacco products.

HR 1136 has been referred to the House Energy and Commerce Committee for consideration. CDA is urging our members to reach out to their lawmakers requesting them to sign on as cosponsors of this important legislation. Rep. Bishop stated that “vapor products offer a promising path for harm reduction for those seeking to quit or limit their smoking. This legislation would ensure the FDA’s regulatory process does not limit the availability of safer tobacco options for those seeking to make use of them.”

The Family Smoking Prevention and Tobacco Control Act (also know simply as The Tobacco Control Act) was signed into law by President Barack Obama on June 22, 2009. The act gives the U.S. Food and Drug Administration (FDA) comprehensive control on tobacco products in the United States, as well as the power to regulate tobacco including the following:

  • Require tobacco companies to submit an ingredients list of any product sold or imported in the United States
  • Require tobacco companies to make public the nicotine content of their products and to adopt standards of nicotine content and to reduce or eliminate other harmful substances present
  • Enlarge warnings on tobacco packaging so that they take up 50% of the front and back panel area Regulate the use of terms such as "mild" and "light" by requiring that tobacco products conform to certain standards regarding these terms

The FDA’s deeming regulations became effective on August 8, 2016, extending the Agency's “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act. CDA’s white paper highlighting the major provisions of this new rule may be found here.

CDA has been working to support efforts in Congress to clarify the FDA deeming authority specifically urging a change in the “predicate date” by which new tobacco and tobacco-derived products such as premium cigars and e-cigarettes must undergo expensive and unnecessary regulatory hurdles imposed by the FDA.

Without such Congressional action, the FDA requires all products that have hit the market since February 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process that could cost upwards of several million dollars per product simply to undergo review.

Because of the speed at which innovation has occurred with vapor products since 2007, essentially all products currently being sold to consumers fall into this regulatory trap. Congress must act to permit innovation to continue for these smoking cessation products that stand to save millions of lives and billions of tax dollars resulting from harm reduction associated with smokers switching to tobacco-free alternatives like e-cigarettes.

The Cole-Bishop bill goes further than FDA’s final rule for newly-regulated vapor products to fill gaps around consumer safety and marketing, addressing concerns expressed during last year’s debate on this issue. The bill ensures FDA regulates e-vapor products in a manner that makes sense in light of the public health opportunities that those products offers and also closes the regulatory gap with respect to consumer protection measures needed for this new product category.

CDA continues to make changing the predicate date a top priority and urges our members to visit our Federal Advocacy Center to send a message to your legislators urging their support for efforts to accomplish this goal. It is important to continue to make your views known on this important issue. Thank you for your support!

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