Recent Changes in US Regulations

By: David C. Steinberg, Steinberg & Associates

Posted: January 30, 2009, from the February 2009 issue of Cosmetics & Toiletries.

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US OTC Drug Labeling
All OTC or nonprescription drugs sold in the United States have required labeling. These drugs are allowed to be sold in the United States by two methods. The first is an approved new drug application (NDA), which is restricted to the company that obtained the application, and to the formulation that was approved. Changes to a formulation but not to the active require an amended NDA prior to the drug’s sale. When the FDA approves the NDA, companies are informed of the permitted claims and the mandated labeling. All NDA OTC drugs must be labeled in the Drug Facts format, which must be placed on the Principal Display Panel of the product package.

OTC drugs sold under an FDA Monograph also have required labeling as stated in the Monograph. These all require the Drug Facts format with the exception of sunscreens. Sunscreens are required to include the same information but there is a stay on requiring the Drug Facts format for sunscreens until the FDA issues its Final Rules on UVA. Once this is published, the agency will publish when Drug Facts and the Drug Facts format must be used, and what new labeling is required. Many companies have been using the Drug Facts format for sunscreens since this law was enacted. Most consumers consider products without Drug Facts to be “old” products.

Drug Facts labels are specific as to font size, bolding and fine line separations, bold and italics, required headers and spacing. See Drug Facts Labeling for a quick review.

Since Drug Facts are unique to the United States, dual labeling is not permitted. Companies cannot label a US-deemed drug to be a cosmetic, even if it is regulated in other countries as a cosmetic, and then use a dual label in either market.

The New Change
On Dec. 22, 2006, Public Law 109-462 was passed. This law requires all OTC drugs sold under a Monograph to include on the label (the Principal Display Panel) a way for consumers to report serious adverse events incurred from using the product. The term serious adverse reaction is defined by law—yet most consumers do not know what this means. Public Law 109-462 was to go into effect in 2007 but the FDA has not required its implementation until January 2009; its enforcement will begin in January 2010.