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News from the FDA

By ALM Staff | Law Journal Newsletters |
April 27, 2004

Content Labeling Requirements Changed for Certain OTC Drug Ingredients

New rules were published on March 24 requiring content labeling (amount present per dosage unit, eg, tablet) and warning labeling for over-the-counter drugs that contain levels of calcium, magnesium, sodium, or potassium that might be harmful to people with certain underlying medical conditions. Mouth rinses, fluoride toothpastes and mouth washes are not covered by this regulation. Under the new rules, the labeling of oral OTC drugs containing sodium, calcium, magnesium or potassium must state the amount of a particular ingredient in each dose if they contain: 1) 5 mg or more of sodium in a single dose; 2) 20 mg or more of calcium in a single dose; 3) 8 mg or more of magnesium in a single dose; or 4) 5 mg or more of potassium in a single dose. The new rules also require new warnings on the label 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 using products for oral ingestion that contain more than: 1) 140 mg of sodium as the maximum daily dose; 2) 3.2 grams of calcium as the maximum daily dose; 3) 600 mg of magnesium as the maximum daily dose; or 4) 975 mg potassium as the maximum daily dose. The effective date of these rules was April 23.

Warning Letters Sent over False Weight-Loss Claims

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