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FDA Halts Sale and Distribution of Adulterated and Misbranded Cigarette Products
Practical Law Legal Update w-000-5945 (Approx. 4 pages)
FDA Halts Sale and Distribution of Adulterated and Misbranded Cigarette Products
by Practical Law Commercial Transactions
| Law stated as of 17 Sep 2015 • USA (National/Federal) |
The Food and Drug Administration (FDA) recently issued orders to prohibit the sale or distribution of certain adulterated and misbranded R.J. Reynolds Tobacco Company cigarette products.
On September 15, 2015, the Food and Drug Administration (FDA) announced that it has issued orders to stop the sale and distribution of four new cigarette products currently marketed by R.J. Reynolds Tobacco Company (Reynolds) because Reynolds’ submissions for these products did not meet Food, Drug and Cosmetic Act (FDCA) requirements. In particular, the FDA found that the Reynolds cigarette products were not substantially equivalent to predicate tobacco products on the market.
Under the FDCA, new tobacco products (any product that was not commercially marketed in the US as of February 15, 2007) may not be legally marketed in the US unless the manufacturer has submitted either a:
- Premarket Tobacco Application (PMTA) to the FDA and obtained a written order permitting it to market the new tobacco product.
- Substantial Equivalence Report to the FDA and obtained an order finding the product to be substantially equivalent to a predicate tobacco product (a product that was commercially marketed as of February 15, 2007).
- Request for an exemption from the substantial equivalence requirements and obtained an exemption.
The cigarette products at issue entered the market during a provisional period established under the Family Smoking Prevention and Tobacco Control Act of 2009. As part of this provisional period, Reynolds was required to submit a Substantial Equivalence Report to the FDA if it wanted its products to remain on the market.
FDA Orders Against Reynolds
The FDA issued these not substantially equivalent orders after finding that:
- The products were not substantially equivalent to their respective predicate products as identified by the manufacturer.
- The manufacturer failed to show that the new products do not raise different questions of public health when compared to their respective predicate products.
The FDA specifically found that Reynolds failed to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol, and/or the addition of new ingredients in the currently marketed products (when compared to the predicate products) do not raise different questions of public health.
The agency’s not substantially equivalent orders apply to the following Reynolds products, which the FDA now considers adulterated and misbranded:
- Camel Crush Bold.
- Pall Mall Deep Set Recessed Filter.
- Pall Mall Deep Set Recessed Filter Menthol.
- Vantage Tech 13.
As a result of these orders, it is illegal either to sell or distribute the products:
- In interstate commerce.
- Received from interstate commerce.
Potential Liability for Violating Federal Tobacco Laws
Companies should always carefully review federal tobacco laws before marketing or selling tobacco products. Failing to do so can result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure or injunctions.
For more information on federal tobacco laws, see Practice Notes, Product Labeling: Tobacco Products and Advertising: Overview: Tobacco.