Earlier today, the U.S. Food and Drug Administration (FDA) released a pre-publication notice of proposed collection of information to the Office of Management and Budget (OMB) for review in the pre-published Federal Register online. This submission follows the draft guidance titled “Dietary Supplement Labeling Requirements and Recommendations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” which the agency published for comment January 2, 2008.

The FDA has since withdrawn the document and removed the posting of the draft guidance from its Web site, to be re-released in the near future. Having seen the current version of the draft notice in advance, however, the Natural Products Association has raised the following concerns:

The Natural Products Association had submitted comments regarding the draft guidance in February 2008. NPA argued that the guidance would impose a financial burden on the industry, and the guidance would require OMB approval before it could be finalized.

Additionally, NPA and our Congressional Champions contend that the draft guidance's requirement that labels must contain a full U.S. mailing address -- the street address or post office box number, city, state and ZIP code of the responsible manufacture (i.e., the manufacturer, packer, distributor or retailer on the dietary supplement label) or a telephone number -- is not required by law and should not be mandated in the final guidance.

This is a departure from the longstanding provisions of the Federal Food, Drug and Cosmetic Act (FFD&CA). This provision presently requires food labels (including dietary supplements) to include the “name and place of business of the manufacturer, packer or distributor” and requires that the statement of the place of business must include the street address, city, state and ZIP code, but that the street address may be omitted if it appears in a current city directory or telephone directory.

The FDA currently estimates that the total cost for the industry complying with this new mandate is $222,400,000 (or $4,000 per SKU).

The NPA strongly encourages all affected members to submit company-specific comments during the 30-day comment period, which will begin immediately after the FDA publishes the draft in the Federal Register. Particularly, comments should include the estimated costs and operational impact the label changes as put forth in the earlier guidance would have on their firm. Aside from the costs that would have to be assumed by the company, members should consider including data regarding the increased cost that would have to be borne by consumers to make these unnecessary and non-statutory required changes.

The NPA does not anticipate the final version of the draft guidance to differ significantly from the previewed version. However, the Natural Products Association will continue to monitor the matter, notify members when the draft guidance is “officially” released, and identify any changes between this document and the final publication.