The comments come in response to the publication of the third version of guidance to supplement labeling, issued this week by the US Food and Drug Administration (FDA).
The guidance has drawn heavy criticism from industry since its initial appearance in 2007, with the main objection being that it was an attempt by FDA fast-track the rule-making process and impose new mandatory requirements on industry without going through a ‘notice and comment’ period.
To read the NutraIngredients-USA.com article on the new guidance issued this week, click here.
Under the new guidance, by September 30 2010 supplement labels must include a full domestic address or telephone number. FDA also said it recommends that labels “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.”
Limits of legal responsibility
Dietary supplement trade groups said they expect their member companies to be “fully compliant” with the requirement to list an address or phone number. However, they made no similar mention in relation to the additional ‘signal language’, which they had previously said would "draw undue attention to the possibility of an adverse event".
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said the group “is pleased to see that FDA expressly recognizes in this final guidance that the introductory statement on the label prior to the address or phone number is only the Agency’s recommendation—it is not a requirement of the law.”
American Herbal Products Association (AHPA) president Michael McGuffin said: “companies may want to consider the limits of their actual legal responsibility when determining whether to adopt FDA’s recommendation for use of this signal language”.
However, a major concern of the trade groups is that the “nonbinding recommendations” in the guidance could be misconstrued as legal requirements, and therefore place firms in compromising positions if they choose not to include the additional language.
“A federal agency’s recommendation as is provided here are often used as binding norms, and are frequently incorporated by bounty hunters in plaintiff lawsuits so it presents a significant potential for problems despite being just a guidance,” said Dan Fabricant, interim executive director and CEO of the Natural Products Association (NPA).
Mister added that “FDA is fully aware of these implications of including this recommendation in the guidance without conducting a notice and comment rulemaking, and yet it forges ahead without any mandate in the law.”