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