Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications.

On August 16, the US District Court for the District of Columbia issued an opinion[1] striking part of the US Food and Drug Administration’s (FDA’s) Guidance for Industry, Demonstrating the Substantial Equivalence of a New Product: Responses to Frequently Asked Questions (Edition 2) (Final Guidance).[2]

The court held that under the Family Smoking Prevention and Tobacco Control Act (TCA), a modification to an existing tobacco product label does not result in a “new tobacco product”[3] and therefore does not require FDA preapproval through a showing of substantial equivalence (SE). Consequently, the court vacated the section of the FDA Guidance that requires a showing of SE for an existing tobacco product labeling change, but upheld the section that requires SE preapproval for product quantity changes because the physical characteristics of the product are altered, which results in a “new tobacco product” under the TCA.

While the court defines “existing products” as those commercially marketed before February 15, 2007, its holding appears to generally affect all tobacco products that are legally marketed (i.e., those addressed by the Final Guidance):

“The court therefore vacates that portion of the Second SE Guidance relating to a labeling change, but affirms that portion relating to a product-quantity change.”[4]

It is unclear how FDA will interpret the decision as it applies to products marketed after February 15, 2007 and whether FDA will interpret the decision to apply broadly to all products covered by the Guidance or only to those existing products marketed before February 15, 2007.

The language of the opinion is not limited to any particular “tobacco product” and appears applicable to all “tobacco products,” including “newly deemed” tobacco products (i.e., e-cigarettes, cigars, etc.).[5] For more information on newly deemed tobacco products, read our May 2016 LawFlash, “FDA Finalizes Tobacco Products Rule.”


In September 2011, FDA issued a document titled “Draft Guidance for Industry and FDA Staff: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (Draft Guidance). The Draft Guidance provided FDA’s thinking regarding when a label change resulted in a “new tobacco product.” It stated that SE preapproval was required when a label change to an existing tobacco product resulted in a “distinct” product such that customers would believe the product to be different from the existing product. In such cases, the manufacturer would be able to submit a “Same Characteristics SE Report”—an abbreviated SE submission. The Draft Guidance provided a chart of examples as to when a change might result in a distinct product. For example, a change in background color from red to green “may” have resulted in a “distinct product,” however, a change in background color from white to cream “may not” have resulted in a “distinct product.” Similarly, the chart stated that a change in a logo image (e.g., from a star to a lion) “may” have resulted in a “distinct product,” but that a change in the logo size “may not” have resulted in a “distinct product.”

Thus, tobacco product manufacturers were left to determine when label changes “may” or “may not” result in a “distinct product” such that it was a “new tobacco product” requiring FDA’s SE preapproval prior to marketing.

The Draft Guidance also addressed the impact of a change in product quantity in a tobacco product. FDA stated that a change in product quantity would constitute a “new tobacco product” under the TCA because the characteristics of the tobacco products (e.g., the amount of ingredients) changed. For example, a change in the number of portioned parts per package (e.g., 20 to 24 cigarettes in a pack) or a change in the weight of a product (e.g., a one-ounce to a two-ounce tin of smokeless tobacco) would constitute a product quantity change such that the product would be a “new tobacco product” requiring an SE preapproval submission—a “Product Quantity Change SE Report.”

On September 8, 2015, FDA released a revised, final version of the Guidance. The Final Guidance offered the same content, but new justifications for FDA’s position as to how label and quantity changes could result in a “new tobacco product.”

On September 30, 2015, a number of large tobacco companies filed suit challenging FDA’s position that a label modification or a quantity change creates a “new tobacco product” triggering the SE preapproval review process.

Label Modification Provision Vacated

The court held that FDA’s reasoning that a labeling modification to an existing product requires an SE preapproval is inconsistent with the intent of the TCA and the Food, Drug and Cosmetic Act (FDCA). The court states in its recent decision that the intent of the US Congress is clear from the plain text and structure of the TCA: First, Congress purposefully chose to omit the word “label” and its iterations from the definition of “new tobacco product.” The words “label” or “labeling” were used no less than 150 times in the TCA, but were omitted from the definition of “new tobacco product.” Instead, Congress chose to define “new tobacco product” and “tobacco product” in terms of physical attributes.

Furthermore, Congress did not use the terms “label” or “labeling” in its SE provisions—Sections 905(j) and 910(a) of the FDCA—and therefore, the court held, Congress did not intend for a label change to trigger the SE preapproval requirement. Thus, the court vacated the provisions of the Final Guidance that state that a label change results in a “new tobacco product.”

In its analysis, the court examined the Medical Device Amendments (MDA) to the FDCA, as the SE provisions of the TCA were largely modeled on those in the MDA. The court read the TCA and MDA provisions congruently, stating that it is appropriate to presume that Congress intended the text to have the same meaning in both statutes.

Quantity Modifications Provision Upheld

The court examined the plain language of the TCA and the definition of “new tobacco product” in its analysis of the quantity modification terms in the Final Guidance. The court states that because Section 910 of the FDCA states that “any modification . . . of a tobacco product” creates a “new tobacco product,” even the slightest change to the physical components of the existing tobacco product would result in a “new tobacco product” and require a showing of SE prior to marketing. Thus, the court states, “an increase or decrease in quantity necessarily entails a change in the amount of the constituent ingredients and additives within a tobacco product, including nicotine.”

Furthermore, Congress indicated that a major motivation behind the TCA was to reduce youth consumption of tobacco products. The Final Guidance relies upon how the quantity or size of a tobacco product can affect tobacco consumption by youth (e.g., barriers to initiation, lowered product harm perceptions). Thus, according to the court, the TCA text, structure, and purpose demonstrate that a change in product quantity results in a “new tobacco product” requiring FDA SE preapproval.

Key Takeaways

  • FDA’s prior guidance that labeling changes to existing products create a “new tobacco product” such that a showing of SE is required prior to marketing under the TCA has been vacated.
  • FDA’s position that product quantity changes create a “new tobacco product” such that a showing of SE is required prior to marketing has been upheld.
  • Manufacturers may be able to submit a Product Quantity Change SE Report for simple changes in product quantities.