This is the third time the guidance document has been published following extensive comments from the supplements industry, which remains strongly opposed to the listing of an address or phone number.
The “nonbinding recommendations” issued today are designed to help manufacturers properly label their supplement products in accordance with the Dietary Supplement and Nonprescription Drug Consumer Protection Act - also known as the serious adverse event reporting (AER) bill.
This was signed into law in December 2006 and came into effect one year later. However, FDA said it is exercising “enforcement discretion” for the new labeling requirements until 2010.
The current guidance, which takes the form of ‘questions and answers’ to the labeling of supplements as required by the act, follows two previous versions published in December 2007 and December 2008.
Full address
As in previous versions, FDA again remains firm that supplement labels must include "a domestic address or domestic phone number through which the responsible person ... may receive a report of a serious adverse event with such dietary supplement." This, it says, is a requirement under section 403(y) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
A ‘domestic address’ includes the street address or P.O. box, city, state, and zip code. A phone number listing must include the area code.
FDA considers this information to be necessary in order for adverse event reports to reach their destination, and said that products will be considered misbranded if they do not include full listings.
The agency said it also recommends that the label “bear a clear, prominent statement informing consumers that they may report serious adverse events to the domestic address or domestic phone number on the label.”
Products must meet these labeling requirements by September 30, 2010.
Opposition
FDA has again invited comments to the latest version of its guidance.
Previous comments from industry to older – but similar – versions have expressed strong opposition to the recommendations.
Trade groups including AHPA, NPA and CRN in the past called for FDA to withdraw the guidance, which they said was essentially imposing new mandatory requirements on industry without going through a notice and comment rulemaking. The recommendations, they said, are counter to current legislation set out in the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which does not require such language.
In addition, industry said that although it agrees that label information must be sufficient to ensure serious advent event reports are received, there is no evidence that this is not achieved with an address that consists solely of the name of the responsible person and their city, state and zip code.
Changing labels to include extra information would have a high cost burden on industry (up to $110m). In addition, adding extra wording to prompt consumers who have experienced an adverse event to contact the manufacturer – as suggested by FDA – would "draw undue attention to the possibility of an adverse event", claims industry.
Nevertheless, the guidance issued today remains consistent with previous versions, despite these concerns.
FDA’s document – Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act – can be accessed here.
For information on how to submit comments, click here.