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Hormone-containing cosmetic preparations
Editorials Hormone-containing cosmetic preparations An increasing number of cosmetic companies are promoting products that contain either therapeutically ineffective and/or subtherapeutic amounts of effective formulations solely to enhance the labeling and/or marketability of their products. One of the most common approaches taken by these companies is to include subtherapeutic amounts of hormones in their products. One such product, distributed interstate, is promoted as a "skin renewal formula." It contains tetraiodothyronine and beta estradiol, both in unspecified amounts. The company reports on their package insert that "all users of (this) will appear younger than their age. Not only can (it) retard the aging process, but it can reverse the aging process to significant degrees. Likewise, blemishes or sundamaged skin can be restored to normal appearance by (it) if the damage is not too great." These claims appear to be unsubstantiated, grossly misleading, and intended to lure the public to purchase the product and thus promote the financial gain of the 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 FDA panel on topically applied hormone-containing drug products for over-the-counter human use reported that "the medical literature indicates that the topical application of hormone-containing drug products may affect the cellular structure of the skin but that these changes are observable only through a microscope." Even the existence of histologic differences is controversial. "The Panel believes that it is possible that the mild dermal edema, 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 Community Professional Bldg., 800 North Central Ave., Kissimmee, FL 32741.
moisturizing cream which does not contain hormones. " The concluding paragraph in the report begins as follows: The Panel further concludes that there is no evidence that using a hormone-containing drug product at the levels which are safe for aTe use will do anything more than using the cream vehicle alone. Therefore, the Panel concludes that these products are ineffective for aTe drug use. When confronted with the preceding evidence, representatives of less candid cosmetic companies indicate 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 the stability of the preparations so that they can be marketed in clear bottles. These products, however, are not necessarily promoted as sunscreens. Similarly, cosmetic preparations may contain relatively small amounts of antibiotic agents to keep the bacterial counts in cosmetics to acceptably low levels and such preparations are not necessarily promoted as antibacterials. In these examples, formulary, not pharmacologic, efficacy is claimed .. This response is misleading. When ultraviolet light-blocking agents and/or small amounts of antibacterial agents are contained in cosmetic products, we need be concerned only that they are safe and have formulary (not pharmacologic) efficacy. These agents are almost always those contained in over-the-counter drug preparations and, as such, have had to be proved pharmacologically safe and effective in the concentrations used. By contrast, hormone-containing over-the-counter preparations usually make claims that reffect alteration of the structure 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 "in827
Journal of the American Academy of Dermatology
Lober
tended to affect the structure or any function of the body of man" and a cosmetic is a product "intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or al-
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 of the stated label claims and is subject to regulation as a drug. Clifford Warren Lober, M.D., Tampa, FL
Unapproved use of minoxidil A new subsection on unapproved use has been added to the Precautions section of the labeling of minoxidil (Loniten), an oral drug approved for the treatment of hypertension. The subsection was necessitated by the increasing use of topical reformulations of minoxidil to treat male pattern baldness following the discovery that hair growth on some part of the body is a side effect in 80% of the patients taking the oral drug. The subsection reads: Unapproved use Use of Loniten Tablets, in any formulation, to promote hair growth is not an approved indication. Clinical trials are in progress and are designed to determine efficacy, dosage, duration of treatment, and actual side effects. Pending completion 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, extemporaneous topical formulations made from Loniten should be considered to share in the full range of contraindications, warnings, and precautions, and adverse reactions listed in this insert. In addition, skin intolerance to the drug and/or vehicle may occur.
Recent reports by Upjohn, Loniten's manufacReprinted from FDA Drug Bulletin, vol. 15, no. 4, p. 38, December, 1985.
828
turer, as well as a report in the literature, 1 have caused concern about the safety of the topical treatment. Upjohn reported that in tests with a topical formulation of minoxidil (Regaine) now in clinical trials, six patients being treated with Regaine have died. One of these deaths was also reported in the journal article. l In addition, one death of a person not enrolled in the company's study has been reported both to FDA and in the journal article. After reviewing these reports, both FDA and Upjohn have concluded that no cause and effect can be established, and, in fact, the death rate in the experimental group is lower than might be expected among an identical group of 4,500 males not using Regaine. Nevertheless, because the safety and effectiveness of topical minoxidil in treating male pattern baldness has not been evaluated, physicians and pharmacists are asked to refrain from recompounding the oral product for topical use. In addition, physicians and pharmacists may want to advise patients that neither FDA nor Upjohn approves of the selling of reformulated minoxidil through advertisements in newspapers and magazines and that such commercialization may be illegal. Until much more is known about the side effects and long-term safety of these formulations, FDA urges individuals not to use them. Regaine is an experimental drug whose safety and effectiveness for growing hair have not been reviewed or approved by FDA. Privately com-
moisturizing cream which does not contain hormones. " The concluding paragraph in the report begins as follows: The Panel further concludes that there is no evidence that using a hormone-containing drug product at the levels which are safe for aTe use will do anything more than using the cream vehicle alone. Therefore, the Panel concludes that these products are ineffective for aTe drug use. When confronted with the preceding evidence, representatives of less candid cosmetic companies indicate 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 the stability of the preparations so that they can be marketed in clear bottles. These products, however, are not necessarily promoted as sunscreens. Similarly, cosmetic preparations may contain relatively small amounts of antibiotic agents to keep the bacterial counts in cosmetics to acceptably low levels and such preparations are not necessarily promoted as antibacterials. In these examples, formulary, not pharmacologic, efficacy is claimed .. This response is misleading. When ultraviolet light-blocking agents and/or small amounts of antibacterial agents are contained in cosmetic products, we need be concerned only that they are safe and have formulary (not pharmacologic) efficacy. These agents are almost always those contained in over-the-counter drug preparations and, as such, have had to be proved pharmacologically safe and effective in the concentrations used. By contrast, hormone-containing over-the-counter preparations usually make claims that reffect alteration of the structure 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 "in827
Journal of the American Academy of Dermatology
Lober
tended to affect the structure or any function of the body of man" and a cosmetic is a product "intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or al-
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 of the stated label claims and is subject to regulation as a drug. Clifford Warren Lober, M.D., Tampa, FL
Unapproved use of minoxidil A new subsection on unapproved use has been added to the Precautions section of the labeling of minoxidil (Loniten), an oral drug approved for the treatment of hypertension. The subsection was necessitated by the increasing use of topical reformulations of minoxidil to treat male pattern baldness following the discovery that hair growth on some part of the body is a side effect in 80% of the patients taking the oral drug. The subsection reads: Unapproved use Use of Loniten Tablets, in any formulation, to promote hair growth is not an approved indication. Clinical trials are in progress and are designed to determine efficacy, dosage, duration of treatment, and actual side effects. Pending completion 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, extemporaneous topical formulations made from Loniten should be considered to share in the full range of contraindications, warnings, and precautions, and adverse reactions listed in this insert. In addition, skin intolerance to the drug and/or vehicle may occur.
Recent reports by Upjohn, Loniten's manufacReprinted from FDA Drug Bulletin, vol. 15, no. 4, p. 38, December, 1985.
828
turer, as well as a report in the literature, 1 have caused concern about the safety of the topical treatment. Upjohn reported that in tests with a topical formulation of minoxidil (Regaine) now in clinical trials, six patients being treated with Regaine have died. One of these deaths was also reported in the journal article. l In addition, one death of a person not enrolled in the company's study has been reported both to FDA and in the journal article. After reviewing these reports, both FDA and Upjohn have concluded that no cause and effect can be established, and, in fact, the death rate in the experimental group is lower than might be expected among an identical group of 4,500 males not using Regaine. Nevertheless, because the safety and effectiveness of topical minoxidil in treating male pattern baldness has not been evaluated, physicians and pharmacists are asked to refrain from recompounding the oral product for topical use. In addition, physicians and pharmacists may want to advise patients that neither FDA nor Upjohn approves of the selling of reformulated minoxidil through advertisements in newspapers and magazines and that such commercialization may be illegal. Until much more is known about the side effects and long-term safety of these formulations, FDA urges individuals not to use them. Regaine is an experimental drug whose safety and effectiveness for growing hair have not been reviewed or approved by FDA. Privately com-