Case # 0000 (00/00/03)

GLOBAL VISION, INC.

Avacor

Advertising Agency:    In-House

Challenger                  The Bald Truth Foundation

Product Type:            Drugs/Health/Health Aids

Issues:                         

Disposition:              Modified

¨      Competent and reliable scientific evidence is required to support health claims relating to the safety and efficacy of drugs and/or dietary supplements

Basis of Inquiry:

As part of its routine monitoring program, NAD requested substantiation for certain claims contained in print, Internet and broadcast advertisements by Global Vision, Inc. ("Global Vision") for its hair growth product, Avacor.  Shortly after NAD opened its inquiry, Spencer Kobren, founder and director of The Bald Truth Foundation ("Bald Truth"), a consumer advocacy group focused on hair loss prevention products, initiated a challenge targeting the same advertisements. In addition to the concerns raised by NAD, Bald Truth challenged labeling claims. Specifically, Bald Truth challenged the failure to disclose the pharmaceutical drug Minoxidil as one of the ingredients of the product. The following are representative of the challenged claims:

¨      "Start growing a full, healthy head of hair today!"

¨      "Avacor shows a 90% success rate in both men and women."

¨      "the most advanced hair re-growth program available anywhere in the world"

¨      "The most advanced hair re-growth system available."

¨      "An all-natural herbal treatment."

¨      "safe and effective for both men and women."

¨      "This procedure has been medically tested"

In the interest of economy, NAD consolidated the monitoring case with the subsequently filed challenge.

Challengers’ Positions:

NAD commenced this inquiry because it was questioned the accuracy of claims in various print, Internet and broadcast advertisements which promised 90% success rate in re-growing hair in both men and women. Additionally, NAD was concerned with the safety and "all-natural" claims made for the product.

Having handled hair re-growth cases in the past [1] , NAD was aware that the only pharmaceutical drugs recognized by the Food and Drug Administration (FDA) for the treatment of hair loss was Minoxidil used as a topical application and Propecia which is taken internally. Upon learning that the product contained Minoxidil, NAD’s concerns were exacerbated, particularly regarding the lack of clear and adequate disclosure of this main ingredient and claims that the product is safe and an "all natural herbal treatment." NAD has noted in the past, consumers experiencing hair loss may be particularly vulnerable to advertising claims that promise a "cure" for hair loss. [2]   In addition to restating NAD’s concerns, the Bald Truth’s challenge focused on the non-disclosure of Minoxidil as an essential ingredient in the product.

By way of background, the challenger explained that Minoxidil in pill form has been widely prescribed for many years to treat high blood pressure. The challenger noted that it is also widely known as the over the counter topical treatment Rogaine, which is used to prevent and treat hair loss. According to the challenger, Minoxidil can have several adverse side effects and, consequently, one should be advised as to its inclusion in an over the counter product. Indeed, argued the challenger, in addition to adverse effects, Minoxidil should not be used by people with certain medical conditions or who are taking certain medications. Additionally, the challenger noted that use of Minoxidil can trigger allergic reactions in some patients and, in rare cases, these reactions can be fatal.

The challenger went on to explain that Avacor, as packaged and labeled, is in violation of Federal Regulations regarding the labeling of over-the-counter (OTC) drugs. According to the challenger, Federal Regulations required that active ingredients be listed as "Active Ingredient:" followed by the established name for the drug, which in this case is Minoxidil. In this regard, the challenger argued that listing Minoxidil by its chemical configuration, i.e. 2,4-diamino-6 piperidinopyrimdine 3 oxide. [3] While the challenger noted that Minoxidil’s chemical configuration was listed on the product’s packaging, the challenger nevertheless argued that doing so was deceptive and misleading. Indeed, the challenger argued that Federal Regulations on labeling requirements for drugs (which have been in effect since 1976) require the active ingredient to be listed as "Active Ingredient:" followed by the established name for the drug, which in this case is Minoxidil. [4] In this regard, the challenger noted that a Guidance published in February 2001 by the U.S. Dept. of Health and Human Services, FDA and Center for Drug Evaluation and Research, which recommends how to properly label OTC drug products, gave the following example of how a Minoxidil product should be labeled: "Active Ingredient: Minoxidil 2%". [5] According to the challenger, not only does the labeling on the Avacor topical formulation omit Minoxidil as the "Active Ingredient," but the "warnings" on the Avacor label do not mention Minoxidil as well.

The Bald Truth also challenged "all natural" claims made by the advertiser for its product. Specifically, the challenger noted that in numerous advertisements the advertiser presented its product as "all natural" and "herbal" with "no side effects." [6]   The challenger argued that by presenting Avacor as "all natural" with "no side effects" and being nothing like Rogaine, misleads consumers into thinking the product does not contain the drug Minoxidil.  In this regard, the challenger asserted that the misbranding/mislabeling of Avacor represented a serious potential health hazard to consumers. [7]

Finally, the challenger took issue with the 90% + success rate claimed by the advertiser for Avacor in a number of its advertisements.  According to the challenger, the FDA accepted percentages of results on Minoxidil are as follows: 26% for moderate to dense regrowth in men, 33%for minimal regrowth in men, 19% moderate growth in women and 40% minimal regrowth in women. [8]

Advertiser’s Position:

At the outset of the challenge, the advertiser advised NAD that it was making changes in its advertising in an effort to address NAD’s concerns. Specifically, the advertiser advised NAD that it was permanently discontinuing the challenged labeling and revising its label to be in complete agreement with the FDA regulations including listing Minoxidil as the Active ingredient in its topical formula and providing the recommended warnings associated with the use of Minoxidil as required by the FDA on its labeling as well. Additionally, the advertiser advised NAD that it would limit its use of the term "all natural" to the herbal oral supplement component of its product. Finally, the advertiser advised NAD that it had permanently discontinued its 90%+ success rate claims in its advertising.   

Notwithstanding these modifications, however, the advertiser defended its advertising claims as truthful and disputed the assertions of the challenger. According to the advertiser, its product, Avacor, is one of the most advanced hair re-growth systems available in the current marketplace.

Background

By way of background, the advertiser explained that it has maintained a clinic in New York City for the past several years where it has evaluated treated hundreds of consumers per year for a variety of hair conditions, particularly the thinning and loss of hair in both men and women due to a heredity condition known as androgenic alopecia, commonly referred to as scalp baldness, or male pattern baldness. The advertiser noted that ninety-five percent of hair loss is of this variety. [9] The advertiser explained that in the male, this type of hair loss is characterized by the upward retreat of the hairline from the forehead to the crown until what is left is a horseshoe shaped fringe around the sides and the back of the head. Female pattern baldness, explained the advertiser, is characterized by a diffuse pattern of hair loss throughout the scalp.

According to the advertiser, the FDA has recognized dihydrotestosterone ("DHT") as the main culprit in male and female pattern baldness. [10] The advertiser noted that DHT is derived from androgen, a male hormone. As it circulates through the bloodstream, the advertiser explained, androgen is converted to DHT by the enzyme 5-alpha reductase. According to the advertiser, those individuals with greater enzyme activity have more DHT binding to hair follicle receptors. As the levels of DHT increase, the advertiser explained, the follicles sprout thinner and thinner hairs until nothing regrows and the follicles eventually wither away. [11]

The advertiser went on to state that an excess of testosterone converting to DHT has been shown to be the cause of an enlargement of the prostate gland known as Benign Prostatic Hypertrophy. According to the advertiser, an oral herbal agent extracted from the Saw Palmetto berries, the fruit of the Serenoa Repens (Sabal Serrulata) plant, has been extensively researched for its anti-androgenic properties. [12]   The advertiser asserted that the same androgenic receptors involved in the interaction of this compound and DHT as found in the human Prostatic tissue are also found in human skin and scalp. The advertiser argued that Sabal Serrulata functions as a natural androgenic blocker by inhibiting the active binding of DHT to the hair follicle receptor site. According to the advertiser, this results in a decrease in the amount of follicular damage and hair loss. [13] The advertiser argued further that the mechanism of action of Sabal Serrulata has been shown to be similar to that of finasteride (Proscar®), a product that has been approved by the FDA for the treatment of Benign Prostatic Hypertrophy, as well as for follicular hair regrowth in men (Propecia®). [14]

Finally, the advertiser explained that the FDA originally approved Minoxidil as a topical preparation to regrow hair due to androgenic alopecia, available by prescription only.  The advertiser noted that Minoxidil is presently approved for over-the-counter sale.

The Avacor System

It was against this background that the advertiser explained how its product was developed and marketed.

The advertiser noted that the Avacor system consists of three components: a shampoo, an herbal oral formula, and a topical formula. According to the advertiser, each component was designed to be used in combination with the other.

a) The Shampoo

The advertiser explained that the shampoo consists of high quality cleansers including Polysorbate 80 as an emulsifying agent. The advertiser noted that while no claims were made regarding the shampoo, the lipophilic agent in the shampoo helps to liquefy and remove excess sebaceous and oily materials, along with dead skin cells from the scalp, thus allowing for better penetration of the topical formula.

b) Herbal Oral Formula

The advertiser explained that the herbal oral formulation consists of Serenoa (Sabal Serrulata), the DHT blocker together with other herbs, minerals, and ingredients to promote the healthy hair follicle. According to the advertiser, the Serenoa helps to block the DHT from the hair follicle, so that it no longer stops growing, thereby helping the hair regrow itself naturally. [15]

c) Topical Formula

The advertiser explained that the topical formulation consists of Minoxidil 2%, which has been approved by the FDA as a hair grower in conditions of androgenic alopecia. [16] According to the advertiser, the topical formulation works mainly at the level of the blood supply to the hair follicles of the scalp.

The Avacor Claims

The advertiser argued that the basic claim for the Avacor system is that the system is safe and effective for androgenic alopecia. According to the advertiser, this basic claim has been demonstrated by the myriad of controlled studies relating to Minoxidil [17] as well as by the controlled studies relating to Serenoa. [18]

With respect to Minoxidil, the advertiser argued that the product works as a vasodilator. The advertiser explained that studies on Minoxidil have found that in balding areas on the scalp there is a reduced blood flow from the small capillaries which decreases the oxygen and nutrients needed to regenerate hair cells. The advertiser asserted that Minoxidil’s vasodilatation action stimulates the blood flow, thereby increasing the flow of oxygen and nutrients, ultimately resulting in the hair follicle becoming larger and thicker. [19]

With respect to the Serenoa Repens (Sabal Serrulata) component of the Avacor system, the advertiser explained that the oral herbal supplement provides the same inhibitory effect on the actions of DHT as the FDA approved pharmacological finasteride. [20] Indeed, argued the advertiser, the FDA approved finasteride (approved as Propecia®) for the treatment of hair loss after it was originally developed and tested for the treatment of Benign Prostatic Hyperplasia ("BPH"). [21] According to the advertiser, studies have shown that the Serenoa Repens used in Avacor has been found to be as effective as Proscar® in the treatment of BPH, resulting in similar improvements of urine flow. [22]

Additionally, the advertiser argued that the safety and efficacy of its product has been tested in a clinical study entitled, "The Biological Effects of Combined Herbal Oral and Topical Fornyulations On Androgenic Alopecia," (the "Avacor Study"). [23]

The Avacor Study

The advertiser submitted in confidence to NAD a full 36-week clinical study which included a 24 week study presented by the advertiser in its advertising. [24]  

According to the advertiser, the data of the Avacor Study represents the results of a scientifically controlled study which shows the positive biological effects, efficacy and safety of a combined, unique herbal oral therapy and topical solution on hair regrowth. The advertiser asserted that a specific research program consisting of close daily monitoring and a highly structured treatment schedule under medical supervision was used. The advertiser explained that two hundred subjects (100 males and 100 females) were enrolled in the study. Further, the advertiser explained that a combination of oral herbal therapy (Saw Palmetto – Serenoa Repens) and a topical formulation (Minoxidil) was evaluated. According to the advertiser, the Avacor Study included the following controls: the monitoring and observation of each of the subjects on a weekly basis throughout the study by the same clinician and reiteration of the same instructions at each visit to the subjects to assure that the instructions were being followed. The advertiser explained that the subjects’ scalps were examined under microscopy and measurements recorded on a weekly basis using an industry standard Hamilton Scale for measuring hair growth on men and an industry standard Ludwig Grade for measuring hair growth on women. The advertiser noted that on the average, active non-vellus (long, thick and pigmented) hair regrowth was noted in 86% of males and 94% of female subjects. According to the advertiser, these results were far superior to results shown in controlled studies using Minoxidil alone. Additionally, the advertiser asserted that of the 200 subjects in the study, no further hair loss was reported as early as one to two months after commencement of treatment.

According to the advertiser, no side effects were reported by any of the subjects. In this regard, the advertiser also noted that its product has been effectively used on approximately 3,000 subjects of all races and hair types at its clinic without any reported or observed side effects.Finally, the advertiser argued that Avacor is sold pursuant to an unconditional guarantee of satisfaction. According to the advertiser, a full refund of the purchase price is given to any consumer claiming to be dissatisfied for any reason.

DECISION

The search for a baldness cure is of ancient origin. Indeed, As NAD has noted in a past decision, a full of head of healthy hair has been, since biblical times, often perceived as an enviable possession for both men and women, mysteriously conferring its owners with the attributes of beauty and strength. [25] Today, however, there are treatments for hair regrowth that have been shown to be effective. As stated previously, NAD evaluated this case against an historical background of "snake oil claims" juxtaposed with legitimate modern medical advancements in this area.

As a preliminary matter, NAD acknowledged that the modifications the advertiser undertook to address NAD’s concerns during the pendency of this case were necessary and appropriate to avoid consumer confusion as well as obviating a potentially serious health hazard for certain consumers. Specifically, NAD acknowledged the following necessary modifications: the discontinuance of the product’s prior labeling and its replacement of labeling in conformance with FDA guidelines including the proper disclosure and labeling of the drug Minoxidil as an active ingredient in the topical formulation with full disclosure of all relevant warnings concomitant to the use of Minoxidil; the discontinuance of "all natural" claims to the product as a whole; and the discontinuance of 90%+ success rates for the product.

Having made this acknowledgment, NAD turned to the remaining issue in the case: i.e.,  the advertiser’s basic claim that its product was safe and effective in the treatment of adrogenic alopecia. As NAD noted in past cases involving similar claims, competent and reliable scientific evidence is required to support health claims relating to the safety and efficacy of drugs and/or dietary supplements. [26]   

After reviewing all of the evidence in the record, NAD determined that the evidence was sufficient to support the advertiser’s basic claim. In reaching this determination, NAD noted that the safety and efficacy of Minoxidil in the treatment of hair loss has been well-established for the past two decades. Additionally, NAD noted that Saw Palmetto (Sabal Serrulata), a dietary supplement, has been recognized by the FDA as a DHT blocker and has been clinically shown to be safe and effective in numerous clinical studies in the treatment of BPH. 

While NAD was troubled by the fact that the Avacor Study was not conducted by an independent researcher, but rather in the advertiser’s own clinic, there were a number of controls present that were not used in clinical studies which NAD found to be problematic in previous hair growth cases. For example, in the "clinical study" in Adam Lewenberg, M.D., [27] the dose of the formula applied was not monitored and was different for different subjects, and the resulting hair quality and hair density was not measured with precision by reliable, valid measurements. Similarly, in the "clinical study" in Advanced Restoration Technologies, Inc., [28] sample sizes were relatively small and limited to males. Additionally, NAD noted that unlike the evidence submitted in prior hair growth cases, there was substantial corroborating research in the instant case that established the efficacy of Minoxidil in the treatment of androgenic alopecia and Sabal Serrulata as a DHT blocker. [29]

For all of the foregoing reasons, NAD determined that the advertiser’s basic claim relating to safety and efficacy was supported by the evidence in the record.

 Conclusion

NAD acknowledged that the following modifications by the advertiser in its advertising and labeling were necessary and appropriate to avoid consumer confusion and a potential health hazard for certain consumers: the discontinuance of the product’s prior labeling and its replacement of labeling in conformance with FDA guidelines including the proper disclosure and labeling of the drug Minoxidil as an active ingredient in the topical formulation with full disclosure of all relevant warnings concomitant to the use of Minoxidil; the discontinuance of "all natural" claims to the product as a whole; and the discontinuance of 90%+ success rates for the product. Additionally, NAD concluded that the evidence in the record was sufficient to support the advertiser’s basic claim in its advertising that Avacor was a safe and effective product in the treatment of androgenic alopecia.

Advertiser’s Statement

Global Vision supports the NAD self-regulatory process and appreciates the
NAD's careful and thorough review of the record in this case. While Global
Vision believes that its prior advertising and labeling were correct,
nevertheless it was pleased accept the modifications recommended by the NAD.
Global Vision is gratified that the NAD has found that its Avacor system is
safe and effective in the treatment of androgenic alopecia and supported by
competent and reliable scientific evidence.