Editorials

Hormone-containing cosmetic preparations

An increasing number of cosmetic compa­nies are promoting products that contain eithertherapeutically ineffective and/or subtherapeuticamounts of effective formulations solely to en­hance the labeling and/or marketability of theirproducts. One of the most common approachestaken by these companies is to include subthera­peutic amounts of hormones in their products. Onesuch product, distributed interstate, is promotedas a "skin renewal formula." It contains tetraio­dothyronine and beta estradiol, both in unspecifiedamounts. The company reports on their packageinsert that "all users of (this) will appear youngerthan their age. Not only can (it) retard the agingprocess, but it can reverse the aging process tosignificant degrees. Likewise, blemishes or sun­damaged skin can be restored to normal appear­ance by (it) if the damage is not too great." Theseclaims appear to be unsubstantiated, grossly mis­leading, and intended to lure the public to purchasethe product and thus promote the financial gain ofthe manufacturer.

The Food and Drug Administration (FDA) re­ported on this subject in the Federal Register (vol.47, No.2, pp. 430-434, Jan. 5, 1982). The FDApanel on topically applied hormone-containingdrug products for over-the-counter human use re­ported that "the medical literature indicates thatthe topical application ofhormone-containing drugproducts may affect the cellular structure of theskin but that these changes are observable onlythrough a microscope." Even the existence of his­tologic differences is controversial. "The Panelbelieves that it is possible that the mild dermaledema, which was difficult to demonstrate his­tologically, may be produced equally well by a

From the Department of Medicine, Division of Dennato!ogy, Uni­versity of South Florida.

Reprint requests to: Dr. Clifford W. Lober, Kissimmee CommunityProfessional Bldg., 800 North Central Ave., Kissimmee, FL32741.

moisturizing cream which does not contain hor­mones. " The concluding paragraph in the reportbegins as follows:

The Panel further concludes that there is noevidence that using a hormone-containing drugproduct at the levels which are safe for aTeuse will do anything more than using the creamvehicle alone. Therefore, the Panel concludesthat these products are ineffective for aTedrug use.

When confronted with the preceding evidence,representatives of less candid cosmetic companiesindicate that hormones may be included in cos­metic preparations not to alter the structure or func­tion of the skin but to affect "formulation." Cos­metic preparations may, for example, contain ul­traviolet light-blocking agents to enhance thestability of the preparations so that they can bemarketed in clear bottles. These products, how­ever, are not necessarily promoted as sunscreens.Similarly, cosmetic preparations may contain rel­atively small amounts of antibiotic agents to keepthe bacterial counts in cosmetics to acceptably lowlevels and such preparations are not necessarilypromoted as antibacterials. In these examples, for­mulary, not pharmacologic, efficacy is claimed..

This response is misleading. When ultravioletlight-blocking agents and/or small amounts of an­tibacterial agents are contained in cosmetic prod­ucts, we need be concerned only that they are safeand have formulary (not pharmacologic) efficacy.These agents are almost always those contained inover-the-counter drug preparations and, as such,have had to be proved pharmacologically safe andeffective in the concentrations used. By contrast,hormone-containing over-the-counter preparationsusually make claims that reffect alteration of thestructure and/or function of the skin. They are,therefore, drugs.

According to the Federal Food, Drug, and Cos­metic Act, as amended, a drug is a product "in-

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Lober

tended to affect the structure or any function ofthe body of man" and a cosmetic is a product"intended to be rubbed, poured, sprinkled, orsprayed on, introduced into, or otherwise appliedto the human body or any part thereof for cleans­ing, beautifying, promoting attractiveness, or al-

Journal of theAmerican Academy of

Dermatology

tering the appearance." If the preparation is pro­moted as an agent that alters the structure or func­tion of the skin, it is de facto a drug regardless ofthe stated label claims and is subject to regulationas a drug.

Clifford Warren Lober, M.D., Tampa, FL

Unapproved use of minoxidil

A new subsection on unapproved use has beenadded to the Precautions section of the labeling ofminoxidil (Loniten), an oral drug approved for thetreatment of hypertension.

The subsection was necessitated by the increas­ing use of topical reformulations of minoxidil totreat male pattern baldness following the discoverythat hair growth on some part of the body is a sideeffect in 80% of the patients taking the oral drug.

The subsection reads:

Unapproved useUse of Loniten Tablets, in any formulation,

to promote hair growth is not an approved in­dication. Clinical trials are in progress and aredesigned to determine efficacy, dosage, durationof treatment, and actual side effects. Pendingcompletion and analysis of these trials, efficacy,dose and duration of therapy are not known.Because systemic absorption of topically ap­plied drugs may occur and is dependent on ve­hicle and/or method of use, extemporaneoustopical formulations made from Loniten shouldbe considered to share in the full range of con­traindications, warnings, and precautions, andadverse reactions listed in this insert. In addi­tion, skin intolerance to the drug and/or vehiclemay occur.

Recent reports by Upjohn, Loniten's manufac-

Reprinted from FDA Drug Bulletin, vol. 15, no. 4, p. 38, Decem­ber, 1985.

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turer, as well as a report in the literature, 1 havecaused concern about the safety of the topical treat­ment. Upjohn reported that in tests with a topicalformulation of minoxidil (Regaine) now in clinicaltrials, six patients being treated with Regaine havedied. One of these deaths was also reported in thejournal article. l In addition, one death of a personnot enrolled in the company's study has been re­ported both to FDA and in the journal article. Afterreviewing these reports, both FDA and Upjohnhave concluded that no cause and effect can beestablished, and, in fact, the death rate in the ex­perimental group is lower than might be expectedamong an identical group of 4,500 males not usingRegaine.

Nevertheless, because the safety and effective­ness of topical minoxidil in treating male patternbaldness has not been evaluated, physicians andpharmacists are asked to refrain from recompound­ing the oral product for topical use.

In addition, physicians and pharmacists maywant to advise patients that neither FDA nor Up­john approves of the selling of reformulated min­oxidil through advertisements in newspapers andmagazines and that such commercialization maybe illegal. Until much more is known about theside effects and long-term safety of these formu­lations, FDA urges individuals not to use them.

Regaine is an experimental drug whose safetyand effectiveness for growing hair have not beenreviewed or approved by FDA. Privately com-