FDA Consumer 10/01/1994 OTC OPTIONS: CONTROLLING DANDRUFF xx FDA banned 27 dandruff shampoo ingredients in 1990. But products containing any of the five ingredients FDA okayed for nonprescription use give with flaky scalps plenty of treatment choice. OTC Options Controlling Dandruff by Audrey T. Hingley If you're troubled by dandruff, that snowy, dust-like stuff that falls from scalp to shoulders, you're not alone: Nearly everyone has dandruff to some degree. Dandruff is treatable with over-the-counter (OTC) products and causes no general health problems or permanent damage. But care must be taken not to confuse simple dandruff with other conditions that also cause flaking of the scalp, such as seborrheic dermatitis or psoriasis. Dandruff occurs when the scalp sheds dead epidermal (skin) cells in large clumps. Dandruff scales appear dry, white or grayish, appearing as small, unsightly patches, especially on top of the head. Scalp cells replenish themselves in a pattern similar to that of hair, but more rapidly: The skin of the head renews itself about once a month. Dead scalp cells are constantly being pushed from the deepest layer of the epidermis to the skin's surface, where they gradually die. Usually the scalp sheds them in a nearly invisible way. But for reasons that are still unclear, cell turnover sometimes becomes unusually rapid, and dead cells are shed as the visible flakes called dandruff. In 1990, FDA banned 27 ingredients in dandruff shampoos because they were not proven safe and effective. Today dandruff can be treated with OTC drug products containing five ingredients FDA has verified as safe and effective: salicylic acid, pyrithione zinc, sulfur, selenium sulfide, and coal tar. FDA allows drug products to be sold without a prescription if they are safe for consumer use without a doctor's supervision and provide adequate detailed information for use on their labels. Approved OTC ingredients for dandruff treatment are available in shampoos, rinses, or in products that users apply and leave on the scalp. Each works in different ways to control dandruff symptoms like scaling or itching. OTC drug products are available in an estimated 750,000 outlets nationwide, including pharmacies and supermarkets, according to the Nonprescription Drug Manufacturers Association (NDMA). NDMA also reports that dandruff is among the top 10 problems consumers are most likely to treat with OTC drug products: 59 percent of the time dandruff sufferers use OTC drug products. Coal-tar preparations and salicylic acid are approved for treating dandruff, seborrheic dermatitis, and psoriasis; pyrithione zinc and selenium sulfide for dandruff and seborrheic dermatitis; sulfur for dandruff; and salicylic acid and sulfur in combination for dandruff treatment. On Jan. 28, 1994, FDA published a final rule amending the monograph published in the Dec. 4, 1991, Federal Register allowing micronized selenium sulfide in a concentration of 0.6 percent to be included as an active ingredient to control dandruff. According to Ida I. Yoder, a chemist in FDA's Office of OTC Drug Evaluation and a member of its drug policy staff, micronized selenium sulfide is a very finely ground form of selenium sulfide, with a particle size of approximately 5 micrometers. Because the selenium sulfide is more finely ground, it can be used at lower concentration levels. "A drug is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body," says Yoder. Shampoos classified as cosmetics cannot make such medical claims. They are marketed for cleansing, beautifying, or promoting attractiveness. If a product only claims to wash off dandruff flakes, it could be considered a cosmetic, Yoder says. But if it claims to prevent or treat the condition, it's considered a drug. What Makes the Flake? Although most people assume dandruff comes from a dry scalp, the opposite is true: People with oily scalps tend to suffer most from dandruff. "This may be due to an oily scalp supporting the growth of yeast in the scalp, which is thought to be instrumental in the development of scaling and scalp irritation," says Joseph P. Bark, M.D., chairman of dermatology at St. Joseph's Hospital in Lexington, Ky. "A large preponderance of males have dandruff, which may suggest some role of androgen hormones in dandruff." Children under 10 rarely have dandruff, but it is common in adolescents. While some experts say it tends to decrease in middle and old age, Bark disputes this. "It really is a postpubescent disease, but I don't believe it diminishes in old age. We see a lot of dandruff and seborrheic dermatitis in stroke patients and in older people," he explains. Bark says that dandruff has its bright side: If the scalp doesn't shed its dead skin cells, the human scalp would be tremendously thick. "But when the cell turnover goes too far and increases, then you get not only visible excess scaling, but redness and itching," he says. "Redness and itching is actually seborrheic dermatitis, and it frequently occurs around the folds of the nose and the eyebrow areas, not just the scalp." Although seborrheic dermatitis mimics dandruff with its flaky scales, the inflammation and itching that accompanies it sets it apart from simple dandruff. OTC preparations are available to help mild cases, but seborrheic dermatitis often is best treated by prescription medications. "All the evidence points strongly to this yeast, known as Pityrosporum ovale, as a causation of seborrheic dermatitis, in that when you treat it with anti-fungal shampoos [such as Nizoral (ketaconazole) a prescription shampoo], you destroy the organism and the condition stops," Bark says. What do you do if you have dandruff but suspect your problem may be a more severe disorder like seborrheic dermatitis? "If you have mild scaling, you can usually take care of it with an OTC dandruff shampoo containing salicylic acid," Bark advises. "Use it for several weeks, and if you don't see a clear- cut improvement in the scaling, consult a dermatologist. A dermatologist can diagnose whether you have a fungus infection of the scalp, seborrheic dermatitis, or some other disorder." A form of seborrheic dermatitis that sometimes alarms new parents is known as "cradle cap." The scaly scalp inflammation is common in newborn babies, although it can occur anytime in infancy. Rubbing warm olive or mineral oil into the baby's scalp and leaving it on overnight can loosen and soften scales, which can be washed off the next day with a mild shampoo. It usually clears up quickly and does not recur. Psoriasis Psoriasis is an inflammatory skin disease in which skin cells replicate at a rapid rate. Although the symptoms of psoriasis-- silvery scales covering reddened areas of the scalp--seem similar to dandruff, psoriasis is very different. New skin cells are produced about 10 times faster than normal, but the rate at which old cells are shed is unchanged. Live cells then accumulate and form the thick patches covered with flaking skin. The scales are heaped-up, and the disorder may involve other areas of the body besides the scalp, most commonly the knees, elbows, back, or buttocks. It can also affect legs, arms, and just about any other part of the body. Psoriasis can be chronic or it may have periods of flare-ups and remission periods. Psoriasis is annoying mainly because of its tendency to return again and again, and because of its unsightly, blotchy appearance. It is more common in whites than in blacks and Asians. If you think you may have psoriasis, consult a doctor about treatment. Coal Tar Coal tar, one ingredient in OTC dandruff products, is a byproduct of treated bituminous coal. In constant exposure to concentrated solutions in industrial settings over long periods (20 to 25 years), coal tar has been associated with skin cancer. But coal-tar products are considered safe for topical use in shampoos because contact with the scalp is only for a short duration. For body seborrheic dermatitis and psoriasis, however, products containing coal tar remain on the skin for longer periods. There are no well-defined, long-term studies that demonstrate how long coal-tar products can be used safely. FDA has noted that prolonged use of such products may not be completely risk free due to possible cancer-causing effects. Coal tar also produces photosensitivity reactions (reactions that occur with exposure to sunlight). Residual amounts of coal tar may remain on the scalp, hair, or surrounding areas after using. So if you're going out in the sun after shampooing with these products, you may want to take extra precautions. FDA requires OTC dandruff products that contain coal tar to state on their labels, "Do not use for prolonged periods without consulting a doctor. Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application." Coal-tar shampoos also tend to give an orange tinge to light- colored hair. Dave Bostwick, a reviewer in FDA's division of anti-infective drugs, Office of Drug Evaluation II, says one alternative to using OTC products to control dandruff is mechanical. "Washing your hair more often means you remove dandruff flakes that otherwise would remain on the head," he says. Other than washing your hair more frequently, there is really no way to control dandruff without treatment. So if you find you're flakier than you'd like to be, OTC drug products may solve your problem. n Audrey T. Hingley is a writer in Mechanicsville, Va. SUBJECT: Denial of use of Dermatron and interference with desired medical treatment, Reno, Dist. Nev.; Civil No. N-91-041-HDM. PETITIONED 1-28-91 by Century Clinic, Reno, Nev., Yiwen Y. Tang, M.D., H.M.D., clinic medical director, Katrina C. Tang, H.M.D., clinic staff member, six named patients of the clinic, and an association of clinic patients, against HHS Secretary Louis W. Sullivan and FDA Commissioner David A. Kessler in a complaint for declaratory judgment and injunction: That the Dermatron was a galvanic skin response measurement device employed by thousands of physicians and that the Dermatron had been in commercial distribution prior to the enactment of the Medical Device Amendments on May 28, 1976, and accordingly had a "grandfather" status; that the Century Clinic and the other plaintiffs had their property seized with attendant threatened criminal prosecution and violations of their civil rights, and the patients had been unlawfully denied access to the Dermatron and other modalities. The asserted unlawful course of action of the defendants included, among other actions, the following: On Sept. 9, 1990, FDA agents, purportedly acting pursuant to a search warrant, seized medical records of 49 patients as well as medications, Dermatrons, and other medical equipment, private files, and other items; and on Oct. 25, 1990, FDA agents, purportedly acting pursuant to a search warrant, seized the medical records of 22 or more active clinic patients, as well as medications, Dermatrons, and other medical equipment, private files, and other items. In addition, the plaintiffs asserted that no statute authorized the defendants to interfere with free choice as to the Dermatron, and that, by virtue of the above actions, the patient plaintiffs had been denied lawful access to the Dermatron. The plaintiffs accordingly prayed for a declaratory judgment that the Dermatron was a lawful and proper medical device, and for a declaratory judgment that the defendants' actions were null and void. The plaintiffs also prayed for a preliminary and permanent injunction against such actions. DISPOSITION: The government generally denied the charges, except for admitting the execution of search warrants and the seizure of Dermatrons, other medical devices, and other objects. The government moved for a stay of the proceedings pending completion of a criminal investigation and potential criminal proceedings. The plaintiffs moved for a preliminary injunction to enjoin the government from harassing and interfering with the doctor-patient relationship between the patients of Dr. Tang and seeking to destroy the homeopathic medical practice of the plaintiffs Tang. The court denied the plaintiffsē motion for a preliminary injunction and granted a stay of the proceedings pending outcome of criminal proceedings. Ultimately, pursuant to a consent decree of permanent injunction against Century Clinic, Inc., and Katrina Tang, this action was dismissed. (Misc. 941; S.J. No. 23) ####