Labeling laws continue to change: government agencies are striving to make food, beverage and drug labels safer and more concise. Here's what that means to you

Food & Drug Packaging, Jan, 2005 by Joanna Cosgrove

For a complete listing of the definitions for each of the aforementioned classifications, log on to the Department of Health's website at www.doh.gov.za /docs/regulations/2004/reg0502.html.

Rx and OTC developments

Late in 2004, mounting health concerns prompted FDA to more closely scrutinize widely used prescription (Rx) drugs. While some popular drugs were completely pulled from the shelves, others have undergone substantial label retooling to better inform the public about the possible health risks or side effects that could occur with consumption.

For example, in December the label on Pfizer's arthritis drug Bextra was amended to include a warning about possible heart and blood-clotting problems. Bextra is a COX-2 inhibitor, similar to Merck's arthritis drug Vioxx, which was pulled it off the market in September because of safety concerns that linked the drug to increased risk of heart attack and stroke. Bextra's new label now features a bold-faced warning against using it after coronary artery bypass surgery, and also notes that studies in arthritis patients have conclusively detected an increased risk of cardiovascular problems. The new label also features a "black box" warning about "rare, serious" skin reactions.

Over-the-counter (OTC) drug manufacturers are preparing for the upcoming May 16, 2005 deadline on which all OTC drug labels must include FDA's new standardized Drug Facts panel. This rule primarily focuses on drug products; however, FDA also considers cosmetic products that make claims to physiologically alter the body's structure (that is, "removes fine lines") to be OTC drugs. Therefore, the packaging for such cosmetics products must include the Drug Facts panel.

The new consumer-friendly Drug Facts label is patterned after the Nutrition Facts food label. It's standardized, easy-to read format allows consumers to better compare OTC medicines and follow dosage instructions. It also uses plain-speaking terms to describe the facts about each OTC drug. For example, "uses" replaces "indications," and other technical words like "precautions" and "contraindications" have been eliminated. The new label also requires a type size large enough to be easily read and specific layout details-bullets, spacing between lines and clearly marked sections-to improve readability.

FDA recently developed a new draft compliance guide for small businesses entitled "Labeling OTC Human Drug Products; Small Entity Compliance Guide." The draft guidance is intended to help small businesses better understand the requirements of the Drug Facts labeling rule and to prepare new labeling within the compliance dates. Comments on the draft are due by Feb. 7, 2005.

HUD packs need bar codes

In the Feb. 26 Federal Register, FDA announced its intent to issue a new rule requiring certain human drug and biological product labels for hospital unit-dose (HUD) packs to have bar codes. The bar code for human drug products and biological products (other than blood, blood components and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code.