Industry asks FDA to align quantitative labeling guidance with other regulators

Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter (OTC) and prescription drugs conflicts with other existing guidelines and advice from other regulators.
 
The comments were made in response to the agency’s call for feedback on the draft guidance, released in September 2022, which recommends quantitative labeling of sodium, potassium and phosphates. (RELATED: FDA issues guidance documents on labeling drug identify, constituents, Regulatory Focus 13 September 2022)
 
In the draft guidance, FDA wrote that quantifying these constituents would help health care providers manage their patients' total daily intake when treating conditions such as heart failure, hypertension or chronic kidney disease.
 
Respondents took issue with a provision of the guidance stating that products containing less than 5 mg of sodium, potassium or phosphorus in a single dose are “not expected to be clinically significant relative to dietary intake, even in patients taking several nonprescription and prescription drugs” and does not need to be reported on the labeling, though manufacturers may add a disclaimer that the product contains less than 5 mg of the relevant ingredient.
 
The agency received six comments on the guidance from pharmaceutical companies and one comment from a consumer trade association.
 
Companies question 5 mg limits
 
Novartis said the 5 mg threshold is not aligned with other regulators, such as the Center for Disease Control’s (CDC) dietary guidelines or European Medicines Agency (EMA) recommendations.
 
For example, CDC recommends that healthy males ages 19 and older reduce sodium intake that exceeds 2,300 mg/day and at least 3,400 mg/day of potassium.
 
EMA requires sodium labelling in excess of 23 mg. Up to 23 mg, the drug product is considered ‘essentially sodium-free’. For potassium, the declaration is “essentially potassium-free” if a drug product is below the 39 mg mark.
 
“It is recommended that where possible, the label requirements be harmonized with other guidance for prescription drug products, to reduce potential confusion,” Novartis wrote.
 
Bristol Myers Squibb also questioned the rationale for the 5 mg per maximum single dose threshold. “It seems that 5 mg is a small fraction of the USDA total daily recommendations for these elements, which range from several hundred mg in the case of phosphorous to, in some age groups, several thousand mg in the case of sodium and calcium. The generation of this type of information will require time and effort to provide time and effort to provide the information requested in this guidance for approved products.”
 
CHPA says guidance conflicts with regulations
 
Also weighing in was the Consumer Healthcare Products Association (CHPA); the group asserted that the consumer healthcare industry “already has specific regulations for the labeling of sodium content (21 CFR 201.64) and for labeling potassium content (21 CFR 201.72) for all OTC drug products.” These regulations, stated CHPA, “are more detailed and contain considerably more labeling requirements than recommendations in the proposed guidance document.”
 
For example, the draft guidance excludes oral products such as dentifrices, mouthwashes or mouth rinses from sodium labeling requirements while these products are included in regulations. Further, the guidance does not address the terms sodium free, very low sodium and low sodium, while the regulations address these claims.
 
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