New York, NY – July 25, 2013 – The National Advertising Division has recommended that Hi-Tech Pharmacal Co., Inc., discontinue certain advertising claims for the company’s Zostrix Hot & Cold Therapy System and Zostrix Foot Pain Relief Cream products, including two “clinically proven” claims and a “Doctor Recommended” claim. NAD found, however, that the advertiser could support claims that the products offer temporary relief of minor pain.

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

NAD requested that Hi-Tech Pharmacal provide substantiation for claims made for Zostrix Hot & Cold Therapy System:

•  “Clinically proven to provide pain relief to 9 out of 10 users.”
•  “Breakthrough Pain Relief!”
•  “The Power of 2 Alternating Therapies Relieves Pain Like No Other!”
•  Back Aches
•  Arthritis
•  Bursitis
•  Body Aches
•  Sore Muscles
•  Sprains
•  “Zostrix Cold Therapy provides cooling pain relief and Zostrix Hot Therapy increases circulation to relax muscles, reduce stiffness and speed healing.”
•  “Zostrix is the only hot and cold topical cream therapy system doctors recommend to relieve joint and muscle pain. Get relief now with Zostrix!”

NAD also requested substantiation for claims made for Zostrix Foot Pain Relief Cream, including:

•  “Clinically proven to provide significant pain relief for painful, tired, overworked feet.”
•  “Doctor Recommended.”
•  “Powerful Strength: Feel it Working Immediately!”

In its response to NAD, the advertiser’s said that Zostrix Hot & Cold Therapy System is comprised of two different products. The “hot” product and the foot cream are both formulated with a.025% concentration of the capsaicin. The “cold” product is a cream that utilizes a 4% concentration of the ingredient menthol. The advertiser noted that many of its claims are permitted by the Food and Drug Administration Monograph for External Analgesic Drug Products for Over-the-Counter Human Use. The advertiser also cited to a number of clinical studies that it contended demonstrate the efficacy of its product and substantiate its claims.

NAD noted that the FDA Monograph allows the advertiser to indicate on the product label that the product is, “[f]or the temporary relief of minor aches and pains of muscles and joints,” and allows it to make other “pain relief” claims.

NAD determined that the advertiser could support claims regarding the temporary relief of minor joint and muscle pain.

However, NAD found the evidence in the record was insufficient to support establishment claims, including “clinically proven to provide pain relief to 9 out of 10 users” and “clinically proven to provide significant pain relief for painful, tired, overworked feet.” NAD recommended that these “clinically proven” claims be discontinued.

NAD also found that the advertiser’s evidence was insufficient to support performance claims regarding its product’s ability to “increase circulation” and “relax muscles, reduce stiffness and speed healing,” and recommended that these claims be discontinued.

NAD recommended that the advertiser modify its “The Power of 2 Alternating Therapies Relieves Pain Like No Other!” and “Breakthrough Pain Relief!” claims to limit them to uniqueness in combining the two therapies and avoid conveying an unsupported superior pain-relief message.

NAD also recommended that the advertiser discontinue the unsupported speed-of-action claims, including “Feel it Working Immediately!” and “Get relief now with Zostrix!”

Finally, given the absence of a well-conducted survey of physicians, NAD recommended that the advertiser discontinue its “Doctor Recommended” claims.

Hi-Tech Pharmacal, in its advertiser’s statement, said that while it “believes that it has adequate substantiation for the claims made, Hi-Tech intends to incorporate NAD’s recommendations in future advertising. Hi-Tech supports and appreciates the opportunity to participate in the self-regulatory process.”