CRN yesterday submitted its comments to the Food and Drug Administration (FDA) in response to the draft guidance issued by the agency on January 2 2008. Entitled Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the draft guidance is intended to assist the dietary supplement industry in complying with the labeling requirements for adverse events reporting. However, according to CRN, 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. FDA 'recommendations' The guidance document, which called for comments from industry within 60 days, 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. However, CRN claims that FDA's use of wording such as "must" and "requires" suggests that "the guidance is not a recommendation at all, but rather a new mandatory requirement for industry." "Such a change in the absence of a clear Congressional mandate deserves full opportunity for input of all stakeholders that a notice and comment rulemaking would afford," stated the group's vice president of scientific and regulatory affairs Andrew Shao in comments to FDA. In addition, FDA's recommendation that prefatory language is used on labels is actually binding to industry because of the impact of civil litigation referencing this guidance language. If manufacturers choose not to follow FDA recommendations and include a full street address on their labels, then they are in effect creating liability in civil product liability litigation, as failure to follow the guidance would most certainly be introduced into evidence held against the company, said CRN. Undue attention FDA's guidance document had also recommended that labels include wording to prompt consumers who have experienced an adverse event to contact the manufacturer. An example provided by the agency is: "To report a serious adverse event or obtain product information, contact…" CRN said it "adamantly opposes" this recommendation on the grounds that it is counter to current legislation set out in the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which does not require such language. In addition, CRN highlights that the purpose of the act is to require manufacturers to report to FDA the serious adverse events that they receive, and to assure that consumers who want to contact the manufacturer have adequate information to do so. Adding extra wording as suggested by FDA would "draw undue attention to the possibility of an adverse event," said the group. This would predispose consumers to expect they will experience an adverse event while using the product, or to incentivize consumers to report more adverse events to manufacturers, it stated. Another important consideration is that additional wording would reduce the blank space on a product label. According to CRN, blank space is equally important in reducing consumers' confusion and directing their attention to product directions and nutrition information. "The decision to 'recommend' additional words on the label should be approached only when there is evidence that the absence of that wording leaves consumers with inadequate information to use the product appropriately. That is not the case here," it said. Costs Another major consideration is the economic burden of label changes on manufacturers, which FDA has downplayed, according to CRN. Changing a large portion - or even all - of dietary supplement labels would amount to a cost of around $54 - $95m to the industry. This would increase to $63 - $110m when using an adjusted annual inflationary rate of 3 percent. In addition, CRN said it believes FDA has underestimated the total number of SKUs at 22,500. According to CRN, the actual number exceeds 50,000, which would amount to a cost closer to $300m. And because manufacturers often print labels months in advance, and any changes often need between 12 and 18 months to be implemented, CRN urged FDA to make a "timely decision" on the fate of the draft guidance. "We believe the draft guidance issued by FDA on January 2, 2008 pertaining to the AER Act violates due process for Agency decision making and is unnecessary, and potentially misleading for consumers," concluded the group. "CRN requests that the Agency make a timely decision and withdraw the guidance, or at a minimum, undergo the normal notice and comment rulemaking process for these interpretations of the Act."