Counselor?s Corner

The first time I had a facial, back in 1984, I was pressured into buying an almond butter facial scrub on my way out. When I got home, it smelled so delicious that I didn?t know whether to spread it on my face or slather it on toast. Twenty years later, we see more and more food ingredients and herbal supplements ingredients used in skin creams, which constitute the largest part of the multi-billion dollar cosmetic market. This is not surprising, since our quickly aging population knows that the complexion is an obvious biological marker for one?s age.

What were once traditionally foods and ingredients to swallow are now making their way into topical cosmetics as the internal becomes external. Ingredients that make skin creams almost good enough to eat include lemon oil, soy phospholipids, oat bran, coconut oil, Ester-C, green tea extract, Co-Q10, wheat germ oil, vitamin E, olive oil, avocado, wild yam, lemongrass, aloe vera, grapeseed extract, caffeine, chamomile, jojoba oil, papaya, kiwi, peach, apricot, mango, hazelnut oil, soybean sterols, licorice extract, evening primrose oil, DMAE, rose hips, eucalyptus oil, rosemary, wild mint, coneflower extract, black currant extract, vanilla oil, lecithin, grape leaf extract, guarana, kola, maté, cucumber, carrot oil and willow bark extract.

And this is just a fraction of the delectable cream, gel and ?butter? ingredients in products with tempting names such as ?Orange Cleansing Souffl?.? At the Functional Foods and Beverages Forum to be held in October in Orlando, Fla., one scheduled talk, ?A Functional Skincare Ingredient: Lutein?The Short Cut Antiordinary Antioxidant,? will argue that the same ingredient in spinach and green leafy vegetables that maintains eye health also has an important role in skin health.

In the Aug. 2 ?Rose Sheet? (a weekly update on the cosmetics industry published by F-D-C Reports), Est?e Lauder predicts that its Origins ?cocoa therapy? products will generate $7 million in its first year of retail. This new chocolate-based body care line, in addition to linking to the company?s wellness theme, will be introduced in partnership with a celebrity pastry chef.

Advertising and label terms like cosmeceutical and aromatherapy, attached to creams containing dietary supplements or ?functional? ingredients, are blurring the lines between the official, statutory categories of cosmetic and drug. The descriptors cosmeceutical and aromatherapy have been in the marketplace for several years, though they are not official terms and are nowhere to be found in the Federal Food, Drug and Cosmetic Act. According to U.S. Food and Drug Administration regulations, these creams are either cosmetics or drugs. Only a few products are in the ?cosmetic drug? category, most notably sunscreens, which prevent skin cancer and moisturize the skin. Cosmetic drugs are governed by specific over-the-counter regulations, called monographs, which, among other things, govern use of descriptors such as sunblock.

There are strict boundaries between the cosmetic and drug FDA categories. Drugs are defined by Congress as ?... articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; articles (other than food) intended to affect the structure or any function of the body (italics added) of man or other animals; articles intended for use as a component of any of the articles listed above (21 U.S.C. [U.S. Code] 321(g)(1), section 201(g)(1) of the FFDCA.

Cosmetics are defined by Congress as ?Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied onto the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; articles intended for use as a component of any such articles,? except soap (21 U.S.C. 321(i), section 201(i) of the FFDCA). My italics show the key distinction: physiological or chemical change versus cosmetic surface improvement.

An FDA Warning Letter dated March 5, 2003, objected to a claim on a skin cream label that it ?helps prevent and temporarily protects chafed, chapped, cracked or windburned skin.? The FDA stated in this letter: ?We are not aware of any substantial scientific evidence that [_______] Protective Skin Cream is generally recognized by scientific experts as safe and effective for the skin barrier uses conveyed in the labeling.? Though the label indicated OTC drug uses, it did not list ?active ingredients? and thus was missing an important requirement for OTC labels. This product was trying to have it both ways—as a cosmetic cream and an OTC drug—resulting in a charge by the FDA of misbranding (mislabeling) and noncompliance.

Perhaps you?re wondering, then, how to keep your ?cosmeceutical? cream legally in the regulatory category of cosmetics? First, make sure that the ingredients are not pharmaceutical ingredients or hormones (which are considered drugs, with the exception of progesterone creams), and that certain peel-type ingredients are not present at too high a concentration (e.g., Currently AHA at higher than 10 percent). Next, label it and market it as a cosmetic, primarily following the regulations in Chapter 700 of Title 21 of the Code of Federal Regulations.

Most important, claims must be limited to statements concerning surface effects only, not those that alter the structure or function of the body or an organ. Thus, a cream may claim to ?nourish weathered skin,? but not to heal burns or wounds, or to cure acne or dermatitis. A gel may claim to add toning and tightening to the face, but may not vow to eliminate or ?melt? cellulite cells from the thighs. A cosmetic spray may be cooling and moisturizing, but not antiseptic, antiviral or antibacterial. A cream may promote a youthful glow, but not be marketed explicitly as an alternative to plastic surgery. Indeed, both the FDA and the Federal Trade Commission have recently been subjecting anti-aging claims to much closer scrutiny, though usually disregarding fanciful claims that are clearly sales puffery, such as ?face lift in a bottle.?

As to the mechanism of action of a ?functional cosmetic,? here arises what I call the regulatory catch-22: If some cream ingredients (e.g., collagen and elastin molecules) cannot penetrate the skin and thus cannot have an effect on, for instance, ?plumping? or rejuvenating the skin, then the FTC could object that such claims are not substantiated with ?competent and reliable scientific evidence.? On the other hand, if the product does indeed work transdermally—travels below the skin levels to deeper, internal tissues (such as fat cells), then the FDA may deem the product to have an effect on the structure or function of the body, and thus consider the ?cosmetic? to be an unapproved new drug. Such was the case for a testosterone gel boasting a ?fast delivery system? into the bloodstream, which, because of these ad claims and the presence of a testosterone precursor, was the subject of an FDA Warning Letter. Thus, transdermal creams, whether they work or not, could be damned either way.

Marketers of cosmetics (as well as dietary supplements) must always bear in mind the principle (and the OTC regulation) concerning Intended Use. The FDA has the authority to examine any and all materials surrounding a product to determine indicia, or indications, by the marketer or labeler of how the product is intended to be used. If there are indications or implications that the cream is intended to be used as a drug (e.g., to treat eczema or skin rashes) rather than simply ?cosmetic? effects, then the product will be considered an unapproved new drug.

Also, note that the FDA will consider and examine infomercials, Internet content, brochures, catalogs and even the language of sales representatives. For example, in one court case, a shampoo was properly labeled as a cosmetic, but a sales representative claimed that the potion would cure baldness, clearly affecting the structure of the body, and thus the shampoo was determined by the judge to be a drug.

Finally, on Feb. 18, the FDA made a public and prominent announcement about a Warning Letter sent in January to a skin cream marketer, in which the agency distinguished between the drug and cosmetic categories by determining intended use. The Warning Letter cited numerous drug claims associated with the company?s topical skin care preparations, noted on both product labeling and the firm?s Web site. Among these claims were increased collagen production; strengthening collagen and elastin fibers; cellulite reduction through cellular stimulation to release stored fat; weight reduction through appetite suppression, increased metabolism and fat burning; and reduced water retention. These claims establish the products? intended use, namely, to affect the structure or function of the body, thus causing them to be drugs under Section 201(g) of the FD&C Act. Significantly, this skin care line of products was named Face Lift and Body Lift.

What about joining forces and combining the categories of cosmetic and supplement? Dietary supplements manufacturers began about five years ago to use dual packaging for vitamins and antioxidant supplements that were blister packed with an antioxidant face cream or gel. Then about four years ago, dietary supplements companies also tried combining minerals and other dietary ingredients with OTC ingredients (such as ibuprofen) in a single capsule. But the FDA objected, via Warning Letters, citing numerous problems (e.g., confusion to consumers and improper labeling).

Skin care companies such as Avon, Olay and L?Oréal are launching dietary supplements to address common cosmetic problems such as dry skin (Wall Street Journal Online, 3/30/04). The FDA would probably not object to cosmetic/supplement companion products, provided that dual packaging is used, and that the labels of both products are scrupulously in compliance, as well as clear to the consumer. In this way—following both the supplements regulations and the cosmetic regulations—dietary supplements and ?functional cosmetic? products may be marketed that truly work from the inside out.

Susan D. Brienza, Esq., is an attorney in the Denver office of the Washington, D.C., law firm Patton Boggs LLP. She practices in the area of regulatory compliance, in FDA law (including DSHEA), organic regulations and FTC law. Her e-mail address is [email protected].

Natural Foods Merchandiser volume XXV/number 10/p. 106-108