FDA Establishes New Policy on OTC Drug Inactive Ingredient Labeling

Date: Dec 18, 2001

The Food and Drug Administration (FDA) has agreed to give companies additional  flexibility in identifying inactive ingredients on the labeling of over-the-counter (OTC) drug products.  Two Citizen Petitions had requested that FDA allow manufacturers to use the phrases “may contain,” “may also contain,” or “and/or” to describe inactive ingredients that may differ when a product is obtained from multiple sources.  FDA granted the Petitions in principle, although the Agency required certain modifications to the disclosure style.  While not the full relief sought in the Petitions, the added flexibility should be helpful to OTC drug manufacturers whose products may vary slightly in their inactive ingredients.

The Agency concluded that it will now permit OTC drug manufacturers to use what it calls “over-inclusive inactive ingredient labeling” (i.e., identifying ingredients that may or may not be present in a particular product).  FDA acknowledged that this has been a regular practice in the OTC drug industry for nearly 15 years without objection from the Agency.  In addition, FDA concluded that the FDA Modernization Act of 1997, which mandated the disclosure of inactive ingredients on OTC labeling, did not prohibit the use of “over-inclusive” labeling.  This issue apparently was not raised during the rulemaking proceeding that led to FDA’s revised OTC drug labeling regulations, now codified in 21 C.F.R. § 201.66. 

Under the statute and regulations, inactive ingredients are to be listed in alphabetical order on a product’s labeling.  According to FDA, using “may contain” or other such statement would violate the statute because all of the ingredients in the product would no longer be disclosed in alphabetical order.   However, FDA will permit those ingredients that may or may not be present in the product to be included in the alphabetical listing with an asterisk next to the ingredient’s name.  The asterisk would then be reprinted at the bottom of the Inactive Ingredients section of the Drug Facts box, with the notation “contains one or more of these ingredients.”  Thus, by way of example, inactive ingredients could be listed as follows: “acacia*, dextrose*, sucrose, xanthum gum*” with the asterisk then indicating the “contains one or more of these ingredients” statement.

The Agency makes clear that “overzealous use of the over-inclusive inactive ingredient labeling could cause products to be adulterated and/or misbranded” because too many alternatives could mislead consumers.  FDA indicates that it will issue a guidance document in the future outlining suggested parameters for the use of over-inclusive inactive ingredient labeling.  For instance, FDA may determine that there should be a limit on the number of ingredients that may be labeled this way or that only certain types of ingredients should be associated with the asterisk (e.g., binders, fillers, etc.).  Certain ingredients may not be suitable for over-inclusive disclosure.  The Agency states that it is “not sure if sweeteners or flavors should be included, since these are important characteristic traits that consumers look for in a product” (even though the Agency’s own example included sweeteners). 

FDA also cautions that over-inclusive labeling should not be used with ingredients that are specifically required to be disclosed for public health reasons, such as ingredients with specific allergenic or dietary concerns (e.g., sodium, aspartame, and (if finalized as proposed) calcium, magnesium, and potassium).

Importantly, the Agency expects products bearing over-inclusive labeling to include a phone number (presumably toll-free) to allow consumers to find out if a particular ingredient is, in fact, present in the product they have purchased (or are about to purchase).  The lot number of the package would need to allow for the identification of the inactive ingredients in the specific product.

For further information about FDA’s OTC drug regulatory requirements, please contact Frederick A. Stearns at 202-434-4288 or via e-mail at stearns@khlaw.com.