Drugs in cosmetics
The saleswoman was young, dewy, and beautiful, with long, honey-colored hair and a carefully made-up face above her white smock. Ten customers were line up at her counter waiting to buy the new cosmetics line that promised to restore the elasticity of youth to their skin.
If you'd asked any of those women, "Are there drugs in your cosmetics?" they'd have been shocked. In fact, some of them were unknowingly lining up to buy cosmetics that are also drugs or drugs that are also cosmetics.
The saleswoman's next customer, for instance, was interested in a new "skin protection" lotion. The customer was a tall, older woman, with a tweed suit and silver-blond hair. She wanted to know what was in the lotions. The saleswoman assured her that it contained ingredients that would make her skin look younger, smoother, and "keep out pollution."
The woman, reassured, plunked down her money for the product and walked off in blissful ignorance.
What she didn't know was that she had just bought an over-the-counter drug masquerading as a cosmetic, in the perfumed and posh surroundings of her favorite department store. Covert cosmetics, or cosmetics which are actually classified as over-the-counter drugs by the Food and Drug Administration, are becoming a fact of life in the $10.6 billion- a-year cosmetics industry in the United STates. The figure for world sales of cosmetics for the last year available, 1978, was $40 billion.
In this case, the "protection" lotion contained what the FCA calls an "active ingredient," industry parlance for a drug which acts as a chemical block against sun, wind or atmosphere. Although the FDA classifies such substances, including sunscreens, as over-the-counter drugs (sold without prescription), consumers may be the last to know it. There is no indication on labels or in ads.
Skin protectants, lipstick which prevent chapping or chafing, lotions which claim to prevent wrinkling, antibacterial deodorant soaps, anti-dandruff shampoos, sunscreens, and anti-cavity toothpastes are among the substances considered over-the-counter drugs by the FDA. But similar products making slightly different claims -- lotins that smooth and beautify, shampoos that wash away dandruff flakes, toothpastes that cleanse but do not claim to fight cavities -- are considered cosmetic by the FDA rather than drugs.
The consumer is caught, puzzled and uninformed, in what sometimes seems like a cosmetics version of the Red Queen's croquet game in "Alice in Wonderland," where rules seem arbitrary, capricious, and perhaps harmful.
Consumers who have been through the chlorophyll rage, though the mink oil, turtle oil, bee pollen, natural fruit, vegetable, and herb cosmetics fashions of the last several years may be unaware of the newest trend. "A Consumer's Guide to Cosmetics," written by Tom Conry and other members of the Science Action Coalition, a nonprofit research group, points it out:
"Recently the industry has taken a different approach and has been glorifying modern technology with ads for 'treatment cosmetics." Couched in scientific-sounding language, the copy promises paramedical benefits if certain 'clinically tested' ingredients are used, or if a skin-care 'system' is followed faithfully. Unfortunately, neither 'nature' nor technology can perform cosmetic miracles. . . ."
The emphasis on treatment is not limited to women consumers, either. Most of the major cosmetics companies also make lotions, colognes, shaving products, etc., for the men's market. Retail sales of men's fragrances, including aftershaves, increased 100 percent from 1972 to 1977, to $368 million, Conry says. The industry expects that figure will double again soon.
And men are finding over-the-counter drugs unexpectedly turning up in their toiletries, too. A man who had Aramis 900 "absolute comfort shave cream" recommended to him for a smooth shave slathered it on one morning and found his face feeling "strange." Some of the cream had spilled over on his mouth, which he says suddenly felt numb. A numbing sensation was also felt on the rest of his face. Puzzled, he checked the cream jar and found that Benzocaine, an active ingredient generally considered an over-the-counter anesthetic, was listed.
The trend appears to be away from the traditional cosmetics role of cleansing and beautification, and toward this emphasis on treatment -- including dermatology and, in some cases, over-the-counter drugs. An FDA spokesman reels off the names of four of the major cosmetics companies as manufacturing product in the twilight area between cosmetics and drugs. Three of these four companies own or are owned by drug or pharmaceutical companies: Charles of the Ritz Group (owned by the Squibb Corporation, a pharmaceutical conglomerate); Elizabeth Arden Inc. (owned by the drug company Eli Lily & Co.); and Revlon Inc. (which owns a series of drug and medical supply companies and laboratories). The fourth, Estee Lauder, produces lines which a spokesman explains have their roots in dermatology. In addition, Coty and LEeming/Pacquin are now owned by Pfizer Inc. (a large health-care concern), Shulton by the American Cynamid co., and Clairol by the Bristol-Myers Co. A new line of doctor-endorsed cosmetics, Dermage, is made by Cosmetic Research Laboratories Inc. And Maybelline is owned by Schering-Plough Corporation, a pharmaceutical company.
Says a spokesman, "Revlon is very much involved in the health care business." It owns several vitamin and pharmaceutical companies as well as diagnostic and health research labs involved in genetic engineering and studies for the National Institutes of Health, in addition to companies which manufacture machines for diagnosis, drugs for skin blemishes and indigestion, and, finally, a line of contact lenses and related lens-care products.
The FDA is a brisk as bottle of astringent on the subject of what separates drugs from cosmetics by definition. The FDA definitions come straight from the federal Food, Drug, and Cosmetic Act, which defines a cosmetic as an article "intended to be rubbed, poured, sprinkled, or sprayed on, introduced to or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. . . ." It excludes soap from the definition.
The FDA defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . and . . . articles [other than food] intended to affect the structure or any function of the body of man." It includes substances used as components of any such articles.
H. J. Eiremann, director of the division of cosmetics and technology at the FDA, says, "Here's the problem: They [the cosmetic manufacturers] are straddling the line between drugs and cosmetics legally. The deciding factor is the intent. The law says if a product is intended to affect the structure or function of the human body or to treat, prevent or ameliorate disease, that product is a drug." He notes that a product that does those things and also cleanses and beautifies may be both. "This is a legal argument. The question of 'intent' is the intent expressed in labeling, what does the manufacturer claim the product will do? . . . And in what the consumer perceives the intent is.
"If the manufacturer loads up his products with stuff like collagen, elastin -- some of them have nucleic acid, and I don't know what the other goodies are -- the question is, what is that product? Estee Lauder has a [line of] prescriptives, three treatments daily, and they throw in all [their] ingredients. I don't know whether the customer perceives she's buying a smoother of skin. You're getting into an area that's iffy." Collagen, elastin, and nucleic acid are all "proteinaceous material," found in living cells.
"Looking at it from the viewpoint of the way the law reads now, a product may be considered misbranded if the labeling is deceptive, if it makes unproven claims and is misrepresented."
In that case, he says, the FDA can move in and either recall the product or get an injunction to prevent further shipment. Usually without proof of misrepresentation, such cases are difficult to prove, require long litigation, and may be overturned in appeals court even if won.
"But if the manufacturer goes a little overboard," says Mr. Eiremann, "and the product clearly makes a hard-core drug claim that it removes wrinkles, plumps up the skin, or penetrates the skin, replenishing the collagan [protein] or rejuvenates the skin until it takes on the appearance of a 20- year-old's, then we don't have to do anything [to prove misrepresentation]." The manufacturer has done it for them, he says.
The question arises as to whether there is a developing interlinking between cosmetic and drug companies. As already noted, at least eight cosmetic companies are owned by or own drug or pharmaceutical firms. The FDA's Eiremann says, "There may be some indirect influence. . . . but it's not a significant factor. There is no recognition in the cosmetics companies per se that this is the way to go. The underlying trend is to go more and more into the treatment area. They do it by using more and more exotic ingredients," which he notes in some cases are over-the-counter drugs.
The Cosmetic, Toiletry and Fragrance Association, the industry trade group, has been concerned enough by the recent trend in hybrid cosmetics that it has sponsored a series of presentations at regional meetings and prepared a briefing paper on the subject. "When is a cosmetic also a drug? -- what you need to know , and why" is the subject of the briefing paper, done by Stephen H. McNamara, CTFA vice-president for legal affairs and general counsel. The paper refers to the FDA definition of drug and cosmetics as "terms of art," and spells out the present regulatory difference between them. "In sum -- it is generally muchm more burdensome, expensive, etc., for an articles to be classified as a drug instead of a cosmetic. . . . Drug status has potentially severe consequences."
What CTFA and its members are worried about is not just the present FDA regulations but future rulings in the FDA "over-the-counter drug review" now under way. Such a review produces "monographs" or drug standards which will standardize labels and warnings.
What's the worst thing thatcould happen in this area as far as CTFA is concerned?
Mr. McNamara answers, "If the FDA were improperly to regulate as drugs products we feel should be subject to regulation only as [cosmetic] products." In that case he says, "I feel confident our members would want to resist that with the FDA or in court."
At present there is a double standard for regulation of drugs and cosmetics. As Mr. Eiremann puts it, "A cosmetic product is innocent until proven guilty; a drug is guilty until proven innocent. It has to be proven safe and effective to be marketed."
In effect, that means that the FDA does not allow drugs to be marketed until they are proven safe and effective, while cosmetics are assumed to be safe and therefore can be marketed without FDA tests. Cosmetics are tested only if there is a public complaint.Nor under the present regulations are the cosmetics manufacturers themselves required to test products for safety or effectiveness, or give the FDA the data if they do test products. Of course, many manufacturers do test out of sense of ethics, he adds, and others test to prevent consumer liability lawsuits.
Many consumers assume that the cosmetics they buy have been FDA-tested for safety, and even some of the cosmetic company sales representatives believe this. An Elizabeth Arden saleswoman discussing its new "Millenium" products volunteered the information that they had been "laboratory tested by the FDA and "the Harvard medical board [sic], so they must be safe."
"Millenium" claims to effect "a dramatic change" in the skin in 14 to 21 days by penetrating as many as 25 cell layers deep to where the new skin is formed, so it becomes "pillowed and cushioned" with moisture.
Consumers who assume that the FDA guards cosmetics as watchfully as it guards food and drugs are wrong. There has not been a revision in the cosmetics laws since 1938 (except for a 1972 ruling on color additives), although there have been major amendments in every other FDA area since then.
In 1939 the total US retail sale of toiletries and cosmetics was only $40 million; by 1958 it had jumped to $1.52 billion; and in 1980, according to CTFA, it was $10.6 billion.
FDA's Mr. Eiremann warns, "We haven't had a botulism or a thalidomide case in cosmetics -- you have to have something to rally around a cause," and suggests that only the pressure of a national tragedy may result in a quick change in the outdated laws.
"We can't be effective with a cosmetics law passed in 1938, when the concept was that cosmetics were innocent until proven guilty. Then they'd put a product on the skin and if the person didn't fall over and die the product was considered safe."
Of course, there is that over-the-counter drug review going on at the FDA, and it may radically alter the rules on hybrid products which are both drugs and cosmetics.Currently, over-the-counter drugs, like cosmetics, are not required to be tested by the FDA before marketing. The law on over-the-counter drugs does, however, require that they identify the "active ingredients" which constitute the drug.
A consumer who wants to avoid buying a cosmetic drug or a drug cosmetic even inadvertently can look for the phrase "active ingredients" on the label as the tip-off to the presence of a drug.
A product that is a cosmetic only will contain a list of ingredients on the cover of the package. a product that is both a drug and a cosmetic will carry a label reading "active ingredients" followed by the phrase "other ingredients."
This is a general rule but not a fail-safe one; Tussy roll-on antiperspirant deodorant for instance, does not list aluminum chlorohydrate as an "active ingredient" although other antiperspirants do, and Tussy includes it in a cosmetics ingredients list.
"This is a fringe area," says Mr. Eiremann. "We are moving into an area in treatment-type cosmetics where there is a trend. The dermatologists and cosmetics manufacturers became friends -- it's a marriage of convenience. A lot of cosmetics companies have dermatologists as consultants and the dermatologist get pretty products."
The FDA plans to do 70 monographs in the next few years, says Dr. William Gilbertson, director of the over-the-counter drug review, adding that the review may take another five to ten years. Dr. Gilbertson, estimates that 20 percent of the drugs now under review will have to be removed from the market as unsafe.
"This came out of the thalidomide tragedy in 1962 -- the FDA has to assure the American public that all its drugs are safe and effective." Dr. Gilbertson says there's "a real possibility, at least in with the ones we've considered, that antidandruff shampoo, lip balms, sunscreens, etc., may be regarded as drugs sometime in the future. They are now subject to interpretation as such."
The four companies cited by the FDA -- Revlon, Arden, Estee Lauder, and charles of the Ritz -- have varying responses to questions about whether some of their products are drugs or cosmetics or both. In general, they are about as eager to discuss the subject as a woman wearing fresh nail polish is to pick up an Angora cat. Some treat the questions as though they were declining an invitation to a tea party or a touch football game.
"The decision [is] that we do not wish to participate in the story," said a spokesman for Elizabeth Arden.
The FDA cites Arden's "Visible Difference" line as falling in the hybrid area. Earlier the spokesman had said, "None of our products do fit that criteria, over-the-counter drugs. We don't make any [such] claims. We are not trying to promote cosmetics as drugs and the fact that we are owned by a drug company has no influence. . . . It's a separate entity and we're not trying to promote the drug angle in our cosmetics. We're a very conservative company. . . .The Charles of the Ritz people are trying to push drugs as cosmetics. They want to promote that."
At Charles of the Ritz they tend to talk about "serious treatment . . . the seriousness of cosmetics."
A spokesmoman for Charles of the Ritz said, "Anything that soothes and heals the skin rather than just making it beautiful is an over-the-counter drug." She said the company manufactured by that definition three over-the-counter drugs in its "Prescribed Skin Care" line: three skin protectants, "Optimum Balance" (also a sunscreen), "Oil Dissolving Treatment," and "Moisture Balancing Daycare," which "also gives temporary relief to minor irritations."
The company is planning to introduce two new products which will be "serious treatment" products, but the spokeswoman declines to say whether they are over-the- counter drugs. The prescribed skin care line, the spokeswoman says, has been tested by the Squibb Medical Institute.
"The FDA has very strict rulings and because we are owned by Squibb we adhere to them. It's a very minor thing but they classify them [as drugs] so we say it because of our Squibb background."
Later a spokesman for Squibb said, "The consumer knows exactly what they're buying here." He compares it to buying something knowing it includes food additives. "All the ingredients have to be listed."
Does his company consider the line blurred between drugs and cosmetics?
"No. There are precise definitions. Or are you talking about over-the-counter drugs that are also cosmetics?"
Reporter: "Is that what they are?"
Squibb spokesman: "Yes. It's the claims you make for a product that determine [how they are regulated]. . . . They are both-the-counter drugs and cosmetics."
When asked whether he anticipates the FDA will move to classify any products as over-the-counter drugs, he suggests that antiperspirants, sunscreens, and skin protectants may be on the list. He added, cryptically, "We do follow the FDA monographs -- all the others don't." The monographs are published guidelines at this point, and have not yet become law.
The FDA had specifically cited Revlon's "Etherea" line and its "european Collagen Complex" in discussing products falling in the gray area between cosmetics and drugs.
A spokesman for Revlon declines to answer most questions but said "Collagen is basically protein.It [isn't] a drug. . . . Etherea is not identified as coming from Revlon," although he admitted it is owned by Revlon.
In a covering letter sent with a bottle of Collagen Complex and a sheaf of brochures he suggested: "As you can see from these materials which describe certain treatment products, our claims are notm in the area which one might connect with 'drugs.' "But magazine ads for European Collagen Complex feature day-by-day photographs which apparently promise "younger looking skin" in 10 days.
The Revlon spokesman during a conversation asked rhetorically, "Are the cosmetics coming out of our labs? The answer is no, no, no, 1,000 times no. This is one of those spooky areas -- consumers want, are more willing to believe , there is cooperative research between large companies. [But] we might as well be owned by banks."
A spokesman for Estee Lauder, which manufacturers Estee Lauder, Clinique, and Aramis products, says "We consider ourselves a cosmetics company with dermatological roots. There's no way we get into pharmaceuticals. We do not address ourselves to pharmaceuticals or the drug end of the spectrum."
The spokesman speaks of "clarifying" the skin, of "exfoliating" it, and describes the Clinque line as "allergy-tested."
"Over and beyond the general testing required, Clinique is allergy-tested by outside companies, not doctors or staff on the premises." The spokesman differentiates between Clinique's "allergy-tested" line and, the commonly used cosmetic phrase "hypo-allergenic" which cosmetics saleswomen frequently define as "fragrance free."
Although the Estee Lauder spokesman says the company does not get into pharmaceuticals, some of its products raise interesting questions. the ads for Clinique "Touch-Stick" for instance, call it a "troubleshooter" which "works on the trouble antiseptically . . . when skin threatens to misbehave," While its Swiss Age-Controlling products for "protection" "create an invisible barrier between you and the harmful effects of sun and pollution" and its "Age-Controlling Creme" promises increased elasticity.
Some of the Lauder products also list active ingredients, generally an indication that what the FDA considers an over- the-counter drug is present.
Consumers browsing through their local drug stores or department stores may also find cosmetics that raise questions. For example: Maybelline's "Moisture Whip" contains the active ingredient Padimate O, a sunscreen sometimes considered an over-the-counter drug, and Helena Rubinstein's Bio-Clear Cleanser contains the active ingredient allantoin as a soother and softener. Allantoin is a natural compound which is found in tobacco seed, sugar beets, wheat sprouts and the excretion of maggots.
The editorial sections of many women's glossy magazines are more liable to promote the new hybrid drug-cosmetics than to examine them critically with an eye to consumer protection, possibly because the magazines' pages are also filled with full-color ads for the same products. One national magazine recently devoted considerable ink to promoting collagen but apparently did not question the claims of the cosmetic companies which sell it.
Dr. Ned Groth, director of public service projects at Consumers Union, says that the question of the "hazards of cosmetics -- the variety of potentially toxic ingredients in cosmetics" has not yet been thoroughly surveyed. Among the hazards, he suggests, may be possible high levels of carcinogenic chemicals in them.
Tom Conry, one of the authors of "The Consumers' Guide to Cosmetics," says, "From what I've seen lately looking at the ads, the thrust by all the cosmetics companies is placed on treatment. They could be very easily walking over the line into the drug area, and that's troubling. . . . Some of the companies, for instance, which are making big claims on collagen are basically sticking their necks way out -- talking about your skin -- saying that if you put it on the skin the skin becomes younger, which is a real crock. . . .
"These companies could be tripping over the line. It's a Catch-22 situation.