FDA Issues New OTC Labeling

Drugs with certain ingredients must carry warnings.


Ben Van Houten

Senior Editor

FDA has issued a final rule that establishes across-the-board content and warning labeling for thousands of orally ingested OTC drugs that contain certain levels of calcium, magnesium, and potassium as active or inactive ingredients.

The rule applies to all OTC drugs intended for oral ingestion, whether marketed under an OTC drug monograph, ongoing OTC drug review, a new drug application, an abbreviated new drug application, or no application. The rule does not require any new reporting or recordkeeping activities, however. 

Under the rule, an OTC drug must include a content statement in the labeling if it contains:

� More than 20 mg of calcium per single maximum recommended dose.
� More than 8 mg of magnesium per single maximum recommended dose.
� More than 5 mg of potassium per single maximum recommended dose.
� More than 5 mg of sodium per single maximum recommended dose.

FDA�s other new rule also requires warning labels to alert people with kidney stones, decreased kidney function due to kidney disease, or people who are on sodium, calcium, magnesium, or potassium-restricted diets, to consult their doctors before ingesting products that contain:

� More than 140 mg of sodium as the maximum daily dose.
� More than 3.2 grams of calcium as the maximum daily dose.
� More than 600 mg of magnesium as the maximum daily dose.
� More than 975 mg potassium as the maximum daily dose.

Those figures can be rounded to the nearest 5 mg if less than 1 g, or to the nearest tenth of a gram if more than 1 g.
Responding to the rule�s publication, acting FDA commissioner Lester M. Crawford, DVM, PhD, said, �These new warnings provide an extra level of safety for people who may be especially sensitive to these commonly used OTC ingredients. Although these ingredients can generally be used safely and provide benefit to many consumers, people with conditions that put them at risk of side effects need to be aware of the presence of these ingredients.�

In the rule, FDA writes that it �has required a magnesium and potassium warning on OTC antacid drug products for almost 30 years, and there is no evidence that these warnings have confused consumers.� The agency also writes that it does not believe that label comprehension studies are necessary to support the labeling change.

In addition, the agency has proposed to extend sodium content labeling requirements to OTC rectal drug products that contain sodium phosphates. FDA is taking this action because people with certain medical conditions may be at risk for serious or life-threatening electrolyte imbalances when using such products.

FDA calls the new labeling requirements necessary to alert people with renal failure, kidney stones, or other conditions, and to assist those who wish to monitor their intake of calcium, magnesium, and potassium. Ingestion of large amounts of calcium can result in renal stones, and both potassium and magnesium can cause serious toxicity in people with impaired renal function, the agency notes. 

Comments on the rule favored a category-by-category approach for labeling, as was done for OTC antacid and laxative drugs. One comment suggested that the across-the-board approach ignores the OTC drug review�s already-established category-by-category method for considering warnings related to levels of magnesium, potassium, and sodium in OTC antacid and laxative drug products.

The final rules go into effect on April 23, 2004. Full compliance with the regulations is required by September 25, 2005. The full rule can be read at www.fda.gov/ohrms/dockets/98fr/04-6480.htm.   

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