NAD Finds BioPharmX can Support Certain Claims for ‘Violet’ Iodine Supplement, Recommends Advertiser Modify Certain Claims

New York, NY – Dec. 5, 2016 – The National Advertising Division has determined that BioPharmX, the maker of “Violet,” an iodine supplement promoted for breast health, can support certain claims for the product and recommended the advertiser modify certain 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.

As part of its routine monitoring efforts, and in conjunction with its initiative with the Council for Responsible Nutrition to expand the review of advertising claims for dietary supplements, NAD requested that the advertiser provide substantiation for claims made in print and internet advertising, including:

  • “Breast Health Starts Here. Violet Iodine is a daily iodine supplement clinically demonstrated to alleviate the common symptoms of cyclic mastalgia and fibrocystic breast condition (FBC), including swelling, tenderness, aches and heaviness and promotes optimal breast health.”
  • “Violet Iodine is designed for women with fibrocystic breast condition . . . who want to proactively take care of their health.”
  • “Violet Iodine has been demonstrated to alleviate premenstrual tenderness, aches, heaviness and swelling in the breasts.”
  • “Violet tablets are different from other iodine supplements. Violet tablets are made with a unique, patented formulation that blends two iodine ingredients in a non-hormonal formulation. These two forms of iodine combine in the stomach to form molecular iodine.”

Following its review of the evidence in the record, NAD determined that the advertiser provided a reasonable basis for its claim that “Violet Iodine is designed for women with fibrocystic breast condition … who want to proactively take care of their health.”

However, NAD recommended that the advertiser modify broad claims regarding “premenstrual breast discomfort” or “cyclic mastalgia” to accurately reflect the fact that molecular iodine, in the same dosage as that found in one Violet iodine pill, has only been clinically “demonstrated” to provide relief to women with fibrocystic breast condition who are experiencing premenstrual symptoms.

NAD determined that the advertiser provided a reasonable basis for the claim that “Violet tablets are different from other iodine supplements. Violet tablets are made with a unique, patented formulation that blends two iodine ingredients in a non-hormonal formulation. These two forms of iodine combine in the stomach to form molecular iodine.”

NAD determined that the claim “Molecular iodine is a form of iodine that has been demonstrated to reduce the symptoms of premenstrual breast discomfort. Molecular iodine has been demonstrated to help restore the natural, healthy balance of breast cells,” does not overstate the performance capabilities of the product.  However, NAD recommended that the advertiser modify the claim to more accurately state that “Molecular iodine is a form of iodine that has been demonstrated to reduce the symptoms of premenstrual breast discomfort associated with fibrocystic breast condition (FBC). Molecular iodine has been demonstrated to help restore the natural, healthy balance of breast cells.”

BioPharmX, in its advertiser’s statement, said the company agreed to comply with NAD’s recommendations.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.