The US Food and Drug Administration is considering the implementation of new dietary supplement labeling that would require labels to carry a full US mailing address of the product’s manufacturer or distributor.
But according to industry trade associations, this would place a high cost burden on manufacturers, which could ultimately also trickle down to consumers. The Natural Products Association (NPA) yesterday urged its members to submit comments to FDA’s draft guidance, which is expected to be released shortly.
FDA published its first version of the draft guidance – entitled Dietary Supplement Labeling Requirements and Recommendations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act – on January 2 2008, and invited comments from interested parties.
The agency has since removed the document from its website, with plans to re-release it in the “near future”, claimed NPA, which said it has seen the current version of the draft notice in advance.
“The NPA does not anticipate the final version of the draft guidance to differ significantly from the previewed version. However, the Natural Products Association will continue to monitor the matter, notify members when the draft guidance is ‘officially’ released, and identify any changes between this document and the final publication,” said the group in a statement.
The guidance document released in January is part of efforts to implement a thorough and consistent adverse events reporting (AER) system.
It recommended that supplement manufacturers include a full domestic address or telephone number on their product packaging, preceded by a "clear, prominent statement" informing consumers that this contact information is for the purposes of reporting serious adverse events associated with the product.
In February, NPA had submitted comments, arguing that the guidance would impose a financial burden on the industry, and that it would require approval from the Office of Management and Budget (OMB) before it could be finalized.
According to NPA, FDA yesterday released a pre-publication notice of proposed collection of information to the OMB for review in the pre-published Federal Register online.
FDA currently estimates that the total cost for the industry to comply with this new mandate is $222,400,000, or $4,000 per SKU.
NPA urged industry members to submit company-specific comments during the 30-day comment period, which will begin immediately after 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,” it said.
“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.”
Another trade association – the Council for Responsible Nutrition (CRN) – also criticized the proposed labeling regulations.
It said that the "recommendations" made by FDA in its document are an attempt to impose new labeling changes through guidance rather than through notice and comment rulemaking.
This, it says, places manufacturers in a compromising position in the event that they do not follow the recommendations. It also misleads consumers as to the safety of products, and it places a "significant economic burden" on companies needing to change their labels.