BBB National Programs Archive

NAD Refers Advertising for MiMedx Wound-Care Products to FDA, FTC for Further Review

New York, NY – May 20, 2014 – The National Advertising Division has referred advertising claims made by MiMedx Group, Inc., for its EpiFix and EpiFix Micronized wound-care products to the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) for further review, after the advertiser declined to participate in NAD’s review of its advertising claims.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

The claims at issue were challenged by Organogenesis, Inc., maker of competing Apligraf and Dermagraft wound-care products.

Organogenesis contended that:

  •  The advertiser is making claims that EpiFix can “treat,” “heal” or “repair” diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), which misleadingly imply that the products are approved as “medical devices” by the FDA.
  •  The advertiser’s comparative claims do not clearly and sufficiently disclose that only the challenger’s products are FDA-approved medical devices that have met FDA’s strict premarketing requirements.
  •  Making a comparison between the two products with regard to cost effectiveness and waste implies that the products are clinically interchangeable, even though there is no data to establish that the products are, in fact, interchangeable with respect to both safety and efficacy.

MiMedx Group stated that, although it has great respect for the NAD process, it believes that the challenge relates to regulatory issues that properly belong before the FDA — not NAD — and therefore declined to participate.

NAD noted in its decision that the FDA mandate to ensure the safety and efficacy of products differs from NAD’s charge – to ensure that advertising claims convey truth and accurate messages to consumers – including professional consumers.

Given the seriousness of the advertising claims at issue, NAD noted, it is disappointed that the advertiser declined to participate in the self-regulatory forum.