Understanding FDA tobacco compliance – legal requirements, warnings, advertisements, and other regulatory restrictions

FDA’s tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products “deemed” to be subject to FDA jurisdiction.  This is a brief compliance guide. 

Three Key Components of FDA’s Tobacco Products Deeming Rule

One way to think about FDA’s tobacco products deeming rule is to think of it in terms of three portions:

  • The deeming provisions
  • Sales and distribution restrictions
  • Warning label requirements

This way of thinking chunks down a big rule into more manageable parts.

Note that our guide is not intended to be exhaustive or comprehensive, but more of an introduction to the compliance process in light of the FDA’s new tobacco products deeming rule.

Some Key Compliance Questions with respect to Tobacco Products

Here is a useful way to start the compliance process.  Go through the checklist and answer the following.

  1. Do you have a tobacco product (see FDCA 201(rr)(1))–including a component or part of a tobacco product, and including a newly deemed tobacco product–as opposed to a drug, medical device, or combination product (excluded per 201(rr)(2))?  If so, you are subject to the FDA tobacco products regulation.
  2. Do you have an accessory of a newly deemed tobacco product? If so, accessories are excepted from FDA tobacco products regulation.
  3. Are you a retailer of tobacco products If so, review FDA prohibitions applicable to retailers such as: (i) prohibition on sales to persons under age 18, and (ii) prohibition on sales through vending machines, except in facilities where the retailer ensures no person younger than 18 is present or may enter at any time.  (See 21 CFR Part 1140)
  4. Are you a manufacturer, distributor, or importer? If so, review FDA requirements such as the required warning label statements.
  5. Are you advertising tobacco products? If so, review FDA required warnings statements on advertisements of tobacco products.

Newly deemed tobacco products include:

  • electronic nicotine delivery systems (ENDS)
  • cigars
  • pipe tobacco
  • cigar tobacco
  • pipes
  • hookah
  • dissolvable nicotine products that do not meet the definition of smokeless tobacco

Existing tobacco products include cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own (RYO) tobacco.

By FDA tobacco products regulation, we refer to key FDA rules such as:

  • Rules prohibiting adulterated or misbranded tobacco products
  • Required FDA submission of ingredient listing and reporting of Harmful and Potentially Harmful Constituents (HPHCs)
  • Prohibition against sale and distribution of modified risk tobacco products unless FDA issues an order authorizing their marketing
  • Prohibition on distribution of free samples
  • Premarket authorizations/orders for new tobacco products

You can find a helpful list of definitions (such as of tobacco products, accessories, and components) on the FDA Small Entity Compliance Guide relating to the tobacco products deeming rule.

You can also find a list of time frames for compliance.  For example, there are different time frames for the labeling requirements; and also for submissions and for obtaining premarket authorization.

Background Law

The Deeming rule expressly extends FDA’s jurisdiction over tobacco products to include all tobacco products, except accessories of newly deemed tobacco products.

Here are some of the key legal and regulatory background documents:

  • Tobacco Control Act (6/22/09) – amends the FDCA by providing FDA authority to regulate tobacco products such as cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
  • Restrictions on the sale and distribution of a tobacco product (FDCA  906(d)); authority to deem products subject to these restrictions (906(b))
  • Deeming rule (Fed Reg. 12342, codified at 21 CFR parts 1100 (the deeming provisions), 1140 (sales and distribution restrictions), and 1143 (warning label requirements).
  • Definition of “tobacco product” (FDCA 201(rr))

FDA Enforcement Authority

FDA enforcement can include

  • warning letters
  • criminal prosecution
  • civil monetary penalties
  • injunction
  • seizure
  • no-tobacco-sale orders.

Contact us if you have questions about compliance with the Deeming rule or FDA tobacco products regulation.

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Michael H Cohen Healthcare & FDA Lawyers

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