ROCKVILLE, Md. The Food and Drug Administration last month gave a one-year reprieve to dietary supplement manufacturers regarding the product label requirements on the reporting of serious adverse events associated with supplement use, the requirement of which went into effect Dec. 22.
The agency reported that even though the law requires dietary supplement manufacturers to provide contact information for adverse event reporting on its labels, the FDA had not had a chance to issue its guidance regarding labeling by Dec. 22. Therefore, the agency will use enforcement discretion through Jan. 1, 2009.
“The labeling requirements of section 403(y) of the FFD&C Act apply to all dietary supplements labeled on or after Dec. 22,” the agency stated. “Therefore, these labeling requirements [i.e. domestic address] are already in effect. However, FDA intends to exercise enforcement discretion for the new labeling requirements until Jan. 1, 2009.”
At issue is the label. While Congress has spelled out a requirement that all manufacturers supply a “domestic address,” which includes a full U.S. mailing address, FDA also wants manufacturers to highlight the address with a prominent statement that tells consumers the contact information is for reporting serious adverse events associated with use of the product.
That added statement is not required by the legislation, FDA has said, but the agency will be looking for that statement beginning Jan. 1, 2009, nonetheless.
The agency has noted it has no objection to a firm’s combining the recommended statement with language informing consumers that the domestic address or phone number on the label may also be used for other purposes. For example, a dual-purpose label statement might be “To report a serious adverse event or obtain product information, contact...” or other similar language, the agency stated.