Breast Discomfort Supplement Claims Were Poor Fit With Study Findings

BioPharmX can support claims its Violet Iodine breast discomfort supplement is designed for women with fibrocystic breast condition, as supported by study data, but must modify claims not specific to the conditions of the women in the study, including those with premenstrual breast discomfort.

BioPharmX Inc. agrees to modify claims for its Violet Iodine supplement related to premenstrual breast discomfort and cyclic mastalgia to adequately reflect a supporting study, according to the National Advertising Division.

The investigative unit of the Advertising Self-Regulatory Council, administered by the Council of Better Business Bureaus, said in a report published Dec. 5 that BioPharmX supports claims that is Violet Iodine is “designed for women with fibrocystic breast condition … who want to proactively take care of their health.”

However, NAD determined that claims the formula can alleviate "premenstrual tenderness, aches, heaviness and swelling in the breasts” and “the common symptoms of cyclic mastalgia” – tenderness associated with hormonal changes – must be modified to reflect that molecular iodine, at the same dosage of one Violet Iodine pill, “has only been clinically demonstrated to provide relief to women with fibrocystic breast condition who are experiencing premenstrual symptoms.”

The claims NAD questioned in a review done in its ongoing monitoring of dietary supplement advertising supported by the Council for Responsible Nutrition were made in advertising on the brand website and in print marketing.

NAD says BioPharmX supports claims that Violet Iodine is “designed for women with fibrocystic breast condition … who want to proactively take care of their health.”

BioPharmX submitted to support its advertising a 1993 article that reviewed three clinical studies on three different iodine formulas and concluded that while all three resulted in clinical improvement of breast symptoms in women with fibrocystic breast disease, molecular iodine was the most beneficial in reducing breast symptoms.

It also provided a six-month, randomized, double-blinded, placebo-controlled multicenter clinical trial of 111 women in 2004 that compared several doses of molecular iodine, including the same dose levels used in Violet Iodine, with a placebo. The study concluded that iodine provides relief in the majority of women who experience chronic cyclic mastalgia associated with fibrocystic breasts.

Violet Iodine, formulated with iodine – 84% potassium iodide, 16% potassium iodate – and selenium, was launched in retail chains in mid-2015 with claims to relieve pre-menstrual breast discomfort. It retails in a 30-count dietary supplement pack for $49.99. (Also see "Consumer Health New Products Roundup" - Pink Sheet, 15 Dec, 2014.)

Menlo Park, Calif.-based BioPharmX, which also develops OTC and Rx drugs for dermatology, aesthetics and women’s health, responded that it agreed to comply with NAD’s recommendations.

Narrowly Focused Study Doesn't Extrapolate

NAD attorneys said one of the three studies described in the 1993 article was a double-blind, placebo-controlled test and worthy of consideration. However, the attorneys said even though the test was methodologically sound, they were “not persuaded that it was sufficiently reliable scientific evidence” to support the efficacy claims made for Violet Iodine.

They found the study more relevant to the performance claims. It indicated the same dosage of molecular iodine as formulated in one Violet Iodine pill provided statistically significant relief from pain associated with fibrocystic breast condition.

However, evidence providing a reasonable basis for claims regarding the ability of Violet Iodine to alleviate FBC symptoms "does not address ‘premenstrual’ discomfort generally or the ‘common symptoms of cyclic mastalgia,” NAD attorneys said.

They explained that NAD's recommendations track with Federal Trade Commission policy that the nature and extent of claims should be directly analogous to the precision and specificity of the data used to substantiate them. (Also see "NAD Sees Health Claims Without Clinical Trials As Risky But Possible" - HBW Insight, 27 Oct, 2015.)

"In the absence of specific product testing, NAD considered whether there was competent and reliable evidence that would reasonably permit extrapolation of the advertiser’s performance claims to the population of women experiencing general premenstrual breast discomfort," the attorneys stated.

An expert for BioPharmX advised NAD that studies establishing that iodine benefits women with FBC also are appropriate as support for claims regarding premenstrual breast discomfort because in the practice of gynecology both terms are used interchangeably to describe the symptoms of cyclical breast discomfort.

However, NAD attorneys said because the study the firm submitted was conducted on a population of women with a “specific type” of cyclical breast discomfort, it “has not shown that it is appropriate to extrapolate the results … to support claims regarding premenstrual (i.e. cyclical) breast discomfort in general.”

“Regardless of whether the terms fibrocystic breast condition and premenstrual breast discomfort are used interchangeably in gynecology, the studies relied upon by the advertiser do not, in fact, ‘demonstrate’ that Violet Iodine alleviates the symptoms associated with premenstrual (i.e. cyclical) breast discomfort in general.”

NAD also considered 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.”

The attorneys said the claim should be modified to indicate 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.”

They said the firm provided a reasonable basis for claims that the product is “different from other iodine supplements” and “Breast Health Starts Here.”

'Literally Truthful' Claims Pulled

BioPharmX said it would discontinue other challenged claims "for reasons other than lack of substantiation" and even though the claims are " literally truthful" or "supported by expert statements."

According to the report, the firm decided to discontinue an implied claim that Violet Iodine treats and/or cures fibrocystic breast condition.

Although FBC is considered "a natural life stage condition" for which there is no "cure," the firm said treatments are available for the symptoms "and there is no legal impediment to marketing a dietary supplement that claims to treat symptoms … as long as the treatment, as in this case, is not for a disease and the claims are substantiated," according to the report.

The firm also said it would pull claims that using the supplement has an "advantage" over using nonprescription pain relievers or nonsteroidal anti-inflammatory drugs and that Violet Iodine "is regulated by the US Food and Drug Administration” and an implied claim that FDA determined it is effective and safe.