FDA Publishes Two Draft Guidances Addressing Non-prescription Drugs Labels

September 15, 2022By Riëtte van Laack

On September 9, 2022, FDA published two notices regarding draft guidance related to labeling of drug products: a notice on the publication of a draft guidance on the Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products and a notice on the publication of a draft guidance on the Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products.  For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products.  FDA’s thinking on the format to be used is quite specific.

The guidance applies to all non-prescription drugs available in the United States, including products approved by FDA and monograph drug products.  It details FDA’s interpretation of the regulation 21 C.F.R. § 201.61 regarding the statement of identity.  FDA interprets the regulation for drug products without an established name (generally monograph drug products do not have an established name) as requiring the name of the active ingredient, the pharmacological category, and strength.  (The regulation does not include a specific requirement to identify the strength of the active ingredient).  In addition, unless it is obvious, the route of administration (ROA) should be included.  For products that include more than one active ingredient, FDA recommends that this information for each active ingredient is vertically aligned.

The regulation requires that the statement of identity must be in “a font reasonably related to the most prominent printed matter on the principal display panel” (PDP).  Consistent with FDA comments in a few Warning Letters,  FDA asserts that this means that the statement of identify must be 50% or more of the size of the most prominent printed matter.  FDA does not explain how it arrived at 50% or more.  (Interestingly, in the 2019 proposal for sunscreen labeling, FDA proposed to require a size at least one quarter the size of the most prominent printed matter).

Without further discussion or explanation, FDA asserts that the requirement for the placement of the statement of identity “in direct conjunction” with the brand or proprietary name “implies that the proprietary name and the statement of identity should not be separated by any intervening matter.” (underline added).

If a monograph includes requirements for the statement of identity that are inconsistent with this guidance, FDA does not intend to take action against companies who follow the guidance.

Draft Guidance on the Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products

For OTC drug products, this guidance (simply) restates the legal requirements included in regulations regarding the quantitative information for sodium and potassium in labeling of OTC products intended for oral ingestion. Interestingly, it provides information for manufacturers who want to include (voluntarily) the phosphorus level in the drug product.

The amount of phosphorus would be the calculated equivalent amount of elemental phosphorus from all the phosphorus-containing components. (FDA stresses that it should not be the amount of phosphate).  As is the case for sodium and potassium, the amount of phosphorus should not be declared if it is less than 5 mg per single dose because that amount is not expected to be clinically relevant.  Also, amounts should be rounded to the nearest 5 mg.  FDA recommends including this information in the Drug Facts under the heading Other information, i.e., in the same sections as where sodium and potassium (if present) will be declared.   If the product contains sodium, potassium, and phosphorus in amounts of 5 mg per single dose, phosphorus must be listed after potassium (which is listed after sodium).  However, if a voluntary statement about the absence of sodium, potassium, or phosphorus is included, it should be the last statement in the “Other Information” section.  The guidance includes several examples of the labeling.

Patients with certain conditions, such as heart failure, hypertension, or chronic kidney disease, are advised to restrict their dietary intake of sodium, potassium and/or phosphorus. Thus, inclusion of information on sodium, potassium, and phosphorus content in a drug may help healthcare providers and patients to select drug products with lower amounts of sodium, potassium, or phosphorus.

For both guidances, comments must be submitted by November 8, 2022, to be considered by FDA.