Georgia C. Ravitz and Naomi L. Halpern, Arent Fox LLP02.01.18
At the close of 2017, the US Food and Drug Administration (FDA) surprised the cosmetics and skin care industries by very quietly withdrawing Import Alert (IA) 66-38. For nearly 30 years, this Import Alert, which was entitled “Skin Care Products Labeled as Anti-Aging Creams,” has directed FDA field personnel working with the US Customs Service (now US Customs and Border Protection) to deny entry to certain skin care and cosmetic products labeled with “exaggerated” anti-aging claims. The withdrawal is a welcome development for the cosmetics industry, where the rapid evolution of skin care technology during the past decade or so has allowed the formulation of highly effective products that address common beauty complaints associated with aging skin.
Although the FDA has not so far provided any rationale for the withdrawal, we believe that the Agency’s action represents a recognition that anti-aging claims of this type are widely and appropriately used in the labeling of domestically manufactured products and thus should not form a basis for import detention. We also believe that withdrawal can be seen as part of a larger re-examination of cosmetics policy under the umbrella of the Trump Administration’s current regulatory reform efforts. This view would be consistent with the fact that in 2017, the FDA issued only three warning letters concerning cosmetics with anti-aging claims, compared with at least 23 issued in 2016; in all three cases, the claims that the companies were making went far beyond true cosmetic claims that the products would improve the appearance of by transiently or superficially affecting aging skin.
In any case, the rescission of the Import Alert should be welcome news for the cosmetics industry for another reason. The Alert cited claims that a product will “counteract” or “retard” the aging process, or “rejuvenate,” “repair,” or “restructure” the skin, as examples of statements that, in the FDA’s view, might cause a skin care product to be deemed an unapproved new drug that is ineligible for importation. Although the IA did not state that the anti-aging terms referenced in the Alert were always impermissible in the labeling of cosmetics, the Alert was often cited, particularly by plaintiffs’ lawyers, as evidence that such claims not only cause a product to be a “drug” but also that the claims are necessarily unsubstantiated.
Thus, not only was IA 66-38 the basis for port-of-entry refusals, it has also been widely used by the class action plaintiffs’ bar as a basis for asserting that various anti-aging cosmetics offered for sale on the domestic market are being improperly promoted in violation of the FDCA, which in turn allegedly violated state consumer protection laws. The withdrawal of the Alert effectively eliminates a significant piece of support for those allegations, and should make it that much easier for cosmetics companies to defend their anti-aging lines in the face of threats from private litigants.
We do not think, however, that the withdrawal of the Alert represents a stark about-face for the FDA. Although it is often said (particularly by plaintiffs’ lawyers!) that marketing a cosmetic product as intended to affect the structure or function of the skin in any way renders the product a drug, (requiring premarket approval by the FDA and subjecting the product to more rigorous post-market oversight than is applied to cosmetics), this formulation of the law has always been an oversimplification that is belied by the FDA’s historical practice as well as case law precedent and market realities.
Drugs v. Cosmetics
It is a truism that, under the FDCA a product’s regulatory status depends primarily upon the use for which it is intended.1 In general terms, products intended to enhance beauty or alter the appearance are cosmetics, while products intended for medical purposes are drugs.2 More specifically, under the FDCA, cosmetics are “articles 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 altering the appearance. . .”3 By contrast, “drugs” are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals [or] articles (other than food) intended to affect the structure or any function of the body of man or other animals . . .”4 It is clear under these definitions that products such as lipstick, mascara and eye shadow are cosmetics while, for example, products intended to treat burns, skin infections or malignancies are drugs.
The lines between the two regulatory definitions blur somewhat, however, where they intersect with respect to skin care products intended simply to improve a healthy person’s appearance by interacting with the skin. It can nevertheless be accurately said that as a general matter, products that affect the structure or function of the skin in a relatively transient and superficial way for purposes of providing a more aesthetically-pleasing look are cosmetics, not drugs. Cosmetic moisturizers, which are used to help repair the lipid barrier and restore hydration, provide an illustration of this point. Although they obviously affect the structure of the skin, the FDA has repeatedly and definitively stated that moisturizers are regulated as cosmetics.
Similarly, notwithstanding their transitory effect on the structure of the skin, facial products containing alpha hydroxy acids (AHAs) and intended to improve the appearance of aging skin are also regulated as cosmetics. The FDA has recognized that cosmetic products containing AHAs may be “marketed for a variety of purposes, such as smoothing fine lines and surface wrinkles, improving skin texture and tone, unblocking and cleansing pores, and improving skin condition in general.” AHAs temporarily smooth wrinkles by interacting with a membrane protein in the skin cells to induce cell death, resulting in mild skin peeling (exfoliation). Nevertheless, despite the fact that these products have and, more significantly, are intended to have, a definite effect on the structure of the skin, AHA-containing skin care products are regulated as cosmetics unless they are promoted for therapeutic uses such as treating acne or repairing UV damage.5
Hair dyes are similarly illustrative of the point. Permanent hair dyes open the outer layer of the hair shaft (cuticle), and deposit dye that reacts with the inner portion of the hair (the cortex), to deposit or remove the color. Typically, peroxide is used to break chemical bonds in hair; dye in the product then becomes bonded to the hair cortex, then conditioners are used to close the cuticle to seal in and protect the new color. Hair colors thus necessarily are intended to affect the structure of the body (hair) but are recognized by FDA as cosmetics.6 It is clear, then, that a claim that a product intended to improve the appearance by means of a minor or temporary effect on the structure of the body is not automatically deemed to be a drug that requires premarket approval in order to be legally marketed.
FDA’s Historical View
The FDA’s view of anti-aging claims has, concededly, varied over time. The Agency’s first real foray into the anti-aging arena occurred in the late 1960s and early 1970s, when FDA became concerned about what it viewed as exaggerated and misleading claims being made for a number of skin care products, resulting in the initiation of enforcement actions against several cosmetics distributors, three of which were ultimately challenged in court, resulting in conflicting legal holdings about the status of products intended to address wrinkles and other signs of aging. The cases involved a product called “Line-Away,”7 which was manufactured by Charles Pfizer & Co., Inc. and distributed by Coty, a product called Magic Secret, which was distributed by Helene Curtis, and a product called Sudden Change, which was distributed by Bishop Industries, Inc.8
In the 1969 case involving Line Away, the United States Court of Appeals for the Third Circuit decided that by promoting the product as “a protein lotion,” and was “packaged under biologically aseptic conditions” in a pharmaceutical laboratory, the distributor implied that the product itself was a pharmaceutical, an impression that thought to be strongly reinforced by language in the advertising materials that characterized the lotion as “super-active” and “amazing,” creating a “tingling sensation” when “at work,” “tightening” the skin and “discouraging new wrinkles from forming.” The court conceded that Coty’s advertising stated that the effect of the lotion was temporary and that frequent application was appropriate, but held that statements in the advertising expressly disclosing that Line Away was not a “hormone” or a “harmful drug” actually suggested that the product was, in fact, a drug.
The same year that the Line Away decision was reached, the United States Court of Appeals for the Second Circuit reached a similar conclusion the case involving Sudden Change, which, like the Coty product, was a bovine albumin lotion. The court in that case held that the distributor’s claims that the product would provide a “face lift without surgery” and would “lift out puffs” rendered the product a drug because it was intended to affect the structure of the skin. Critically, however, the Sudden Change court explained that “the question of whether a product is “intended to affect the structure . . . of the body of man . . . ” is to be answered by considering, first, how the claim might be understood by the “ignorant, unthinking or credulous” consumer, and second, whether the claim as so understood may fairly be said to constitute a representation that the product will affect the structure of the body in some medical-or drug-type fashion; i.e., in some way other than merely “altering the appearance.”
Two years later, the Magic Secret case was decided by the United States District Court for the District of Maryland. Like Line Away and Sudden Change, Magic Secret was a clear protein lotion intended to smooth facial wrinkles by forming an adhesive film which contracts as the liquid in the lotion evaporates. The court held, however, that the product, as advertised, was not a “drug” within the meaning of the FDCA, because the claims that it was a “pure protein” which causes an “astringent sensation,” were not “so extravagant and did not carry such drug connotation that a prospective purchaser, against background of constant exposure to puffing and extravagant claims with respect to cosmetics, would expect anything other than possibility that she might look better.”
Claims Evolve
How to make sense of these not entirely consistent opinions, then? The overall message of these three seminal cases is that cosmetic distributors must be wary of where the line is between cosmetic claims and drug claims, and statements that implicitly convey that a product is intended to function in a manner similar to a drug (as in the Line Away case) cross the line. However, as the holding of the Second Circuit in the Sudden Change case inherently recognizes, the standard for what constitutes a cosmetic claim is an evolving one.
As the Sudden Change court explained, “claims which have become so associated with the familiar exaggerations of cosmetics advertising that virtually everyone can be presumed to be capable of discounting them as puffery,” do not render a product a drug.9
Accordingly, while a claim of an astringent effect was thought in 1969 to reinforce a drug message, by 1971, it was considered to be essentially puffery. In the intervening decades, many of the factors that the court in the Line-Away case relied upon to establish that the product was a drug have become widely accepted as cosmetic claims. For example, the Line Away court was concerned that the advertising of the product conveyed that the product was intended as a drug because it “suggests that the lotion nourishes the skin.”10 However, nourishing the skin is, today, a common cosmetic claim that no one with even a passing familiarity with the industry or the regulatory scheme would suggest renders a face lotion a drug. Similarly, no one today would take the view that a claim that a product creates a tingling sensation or a claim that a product was packaged under aseptic conditions is evidence that the distributor intends the product to function as a drug. Indeed, the fact that the cosmetics marketplace is flooded with products bearing anti-aging, rejuvenating, line-reducing, firming, toning, brightening, and lifting claims speaks volumes about the types of claims that, even if they once might have been viewed otherwise, today have a firm and accepted place in the cosmetics aisle.
“But wait,” you may say. What about all of the Warning Letters that the FDA has issued to cosmetics companies? Don’t these letters constitute proof that a claim to remediate lines and wrinkles and other signs of aging are “drug claims”? The answer is no. It is true that in the late 1980s, the Agency did, in a series of Warning Letters and related follow-up correspondence, appear to embrace such an extremely restrictive view, stating that it considered claims that a product “will affect the body in some physiological way” to be drug claims, “even if the claim is that the effect is only temporary.” Therefore, the Agency asserted, most anti-aging and skin physiology claims would be considered to be drug claims. However, the FDA’s position at that time was not altogether consistent with legal precedent or Agency prior practice, and the FDA has not asserted such a restrictive position in the ensuing 30 years. Rather, both the FDA and the industry have interpreted the law in a more practical and intellectually honest manner, recognizing that not every claim that a product affects the structure or function of the skin renders the product a drug.
More specifically, claims that use terms like “anti-aging,” “regenerating” or “rejuvenating” in a manner that reasonably conveys simply that the product temporarily improves the appearance of aging skin or reduces fine lines or wrinkles, as well as claims that a product reduces the appearance of wrinkles, makes skin appear more plump, or improve the skin’s firmness or tonicity, are not typically regarded as drug claims unless accompanied by additional indicia that the distributor intends that a particular product be used to provide drug-like effects. In fact, we are aware of few, if any, instance in the past 25 year in which the Agency has objected to anti-aging claims unless the labeling or promotional materials for the product have also suggested or implied that the product could be used to increase collagen or elastin production, to provide or stimulate stem cells, blood circulation or angiogenesis, to treat or prevent skin diseases or disorders, to heal wounds, to reduce scarring or blemishes, to repair cellular or DNA damage, or to function as a substitute for facial surgery, injections or other FDA-approved skin treatments.
In short, and as the Second Circuit recognized nearly 50 years ago, the test of whether a skin care product is a cosmetic or a drug is not simply whether it is intended to have some effect on the structure of the skin. Rather, while claims concerning non-transient, non-trivial or therapeutic structural changes to the skin are drug claims, claims that are focused on transient or minor structural changes intended to enhance beauty are properly considered cosmetic claims. Moreover, the line between a “drug” claim and a “cosmetic” claim is not a static one, and many claims that may once upon a time have been viewed as drug claims are now acceptable in the cosmetics aisle. Against this backdrop, FDA’s withdrawal of the IA 66-38 may be seen as a simple recognition of the realities of the skin care marketplace in light of current state of anti-aging science and technology.
References
Georgia Ravitz is a partner in the firm’s Washington, DC, office and leads the Consumer Product Safety practice, and is a senior partner in the firm’s Food & Drug (FDA), Agriculture, and Advertising practices. She focuses on food and drug law and regulatory policy governing the regulation of a variety of categories, including cosmetics, health and beauty aids. Ravitz also focuses on the laws and regulations pertaining to consumer products generally, and those administered by the US Consumer Product Safety Commission (CPSC) and various state and local regulatory agencies responsible for consumer health and safety as well as the Federal Trade Commission (FTC).
Email: georgia.ravitz@arentfox.com
Naomi Halpern’s practice involves advising clients on a broad range of regulatory issues involving the Food and Drug Administration (FDA) with respect to pharmaceuticals (including branded, generic prescription, and over-the-counter drugs), medical devices, foods, cosmetics, and dietary supplements, as well as those involving oversight by the US Department of Agriculture (USDA) of food safety and labeling. She also advises on the laws and regulations relating to consumer products administered by the US Consumer Product Safety Commission (CPSC).
Email: naomi.halpern@arentfox.com
More info: Arent Fox, www.arentfox.com
Although the FDA has not so far provided any rationale for the withdrawal, we believe that the Agency’s action represents a recognition that anti-aging claims of this type are widely and appropriately used in the labeling of domestically manufactured products and thus should not form a basis for import detention. We also believe that withdrawal can be seen as part of a larger re-examination of cosmetics policy under the umbrella of the Trump Administration’s current regulatory reform efforts. This view would be consistent with the fact that in 2017, the FDA issued only three warning letters concerning cosmetics with anti-aging claims, compared with at least 23 issued in 2016; in all three cases, the claims that the companies were making went far beyond true cosmetic claims that the products would improve the appearance of by transiently or superficially affecting aging skin.
In any case, the rescission of the Import Alert should be welcome news for the cosmetics industry for another reason. The Alert cited claims that a product will “counteract” or “retard” the aging process, or “rejuvenate,” “repair,” or “restructure” the skin, as examples of statements that, in the FDA’s view, might cause a skin care product to be deemed an unapproved new drug that is ineligible for importation. Although the IA did not state that the anti-aging terms referenced in the Alert were always impermissible in the labeling of cosmetics, the Alert was often cited, particularly by plaintiffs’ lawyers, as evidence that such claims not only cause a product to be a “drug” but also that the claims are necessarily unsubstantiated.
Thus, not only was IA 66-38 the basis for port-of-entry refusals, it has also been widely used by the class action plaintiffs’ bar as a basis for asserting that various anti-aging cosmetics offered for sale on the domestic market are being improperly promoted in violation of the FDCA, which in turn allegedly violated state consumer protection laws. The withdrawal of the Alert effectively eliminates a significant piece of support for those allegations, and should make it that much easier for cosmetics companies to defend their anti-aging lines in the face of threats from private litigants.
We do not think, however, that the withdrawal of the Alert represents a stark about-face for the FDA. Although it is often said (particularly by plaintiffs’ lawyers!) that marketing a cosmetic product as intended to affect the structure or function of the skin in any way renders the product a drug, (requiring premarket approval by the FDA and subjecting the product to more rigorous post-market oversight than is applied to cosmetics), this formulation of the law has always been an oversimplification that is belied by the FDA’s historical practice as well as case law precedent and market realities.
Drugs v. Cosmetics
It is a truism that, under the FDCA a product’s regulatory status depends primarily upon the use for which it is intended.1 In general terms, products intended to enhance beauty or alter the appearance are cosmetics, while products intended for medical purposes are drugs.2 More specifically, under the FDCA, cosmetics are “articles 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 altering the appearance. . .”3 By contrast, “drugs” are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals [or] articles (other than food) intended to affect the structure or any function of the body of man or other animals . . .”4 It is clear under these definitions that products such as lipstick, mascara and eye shadow are cosmetics while, for example, products intended to treat burns, skin infections or malignancies are drugs.
The lines between the two regulatory definitions blur somewhat, however, where they intersect with respect to skin care products intended simply to improve a healthy person’s appearance by interacting with the skin. It can nevertheless be accurately said that as a general matter, products that affect the structure or function of the skin in a relatively transient and superficial way for purposes of providing a more aesthetically-pleasing look are cosmetics, not drugs. Cosmetic moisturizers, which are used to help repair the lipid barrier and restore hydration, provide an illustration of this point. Although they obviously affect the structure of the skin, the FDA has repeatedly and definitively stated that moisturizers are regulated as cosmetics.
Similarly, notwithstanding their transitory effect on the structure of the skin, facial products containing alpha hydroxy acids (AHAs) and intended to improve the appearance of aging skin are also regulated as cosmetics. The FDA has recognized that cosmetic products containing AHAs may be “marketed for a variety of purposes, such as smoothing fine lines and surface wrinkles, improving skin texture and tone, unblocking and cleansing pores, and improving skin condition in general.” AHAs temporarily smooth wrinkles by interacting with a membrane protein in the skin cells to induce cell death, resulting in mild skin peeling (exfoliation). Nevertheless, despite the fact that these products have and, more significantly, are intended to have, a definite effect on the structure of the skin, AHA-containing skin care products are regulated as cosmetics unless they are promoted for therapeutic uses such as treating acne or repairing UV damage.5
Hair dyes are similarly illustrative of the point. Permanent hair dyes open the outer layer of the hair shaft (cuticle), and deposit dye that reacts with the inner portion of the hair (the cortex), to deposit or remove the color. Typically, peroxide is used to break chemical bonds in hair; dye in the product then becomes bonded to the hair cortex, then conditioners are used to close the cuticle to seal in and protect the new color. Hair colors thus necessarily are intended to affect the structure of the body (hair) but are recognized by FDA as cosmetics.6 It is clear, then, that a claim that a product intended to improve the appearance by means of a minor or temporary effect on the structure of the body is not automatically deemed to be a drug that requires premarket approval in order to be legally marketed.
FDA’s Historical View
The FDA’s view of anti-aging claims has, concededly, varied over time. The Agency’s first real foray into the anti-aging arena occurred in the late 1960s and early 1970s, when FDA became concerned about what it viewed as exaggerated and misleading claims being made for a number of skin care products, resulting in the initiation of enforcement actions against several cosmetics distributors, three of which were ultimately challenged in court, resulting in conflicting legal holdings about the status of products intended to address wrinkles and other signs of aging. The cases involved a product called “Line-Away,”7 which was manufactured by Charles Pfizer & Co., Inc. and distributed by Coty, a product called Magic Secret, which was distributed by Helene Curtis, and a product called Sudden Change, which was distributed by Bishop Industries, Inc.8
In the 1969 case involving Line Away, the United States Court of Appeals for the Third Circuit decided that by promoting the product as “a protein lotion,” and was “packaged under biologically aseptic conditions” in a pharmaceutical laboratory, the distributor implied that the product itself was a pharmaceutical, an impression that thought to be strongly reinforced by language in the advertising materials that characterized the lotion as “super-active” and “amazing,” creating a “tingling sensation” when “at work,” “tightening” the skin and “discouraging new wrinkles from forming.” The court conceded that Coty’s advertising stated that the effect of the lotion was temporary and that frequent application was appropriate, but held that statements in the advertising expressly disclosing that Line Away was not a “hormone” or a “harmful drug” actually suggested that the product was, in fact, a drug.
The same year that the Line Away decision was reached, the United States Court of Appeals for the Second Circuit reached a similar conclusion the case involving Sudden Change, which, like the Coty product, was a bovine albumin lotion. The court in that case held that the distributor’s claims that the product would provide a “face lift without surgery” and would “lift out puffs” rendered the product a drug because it was intended to affect the structure of the skin. Critically, however, the Sudden Change court explained that “the question of whether a product is “intended to affect the structure . . . of the body of man . . . ” is to be answered by considering, first, how the claim might be understood by the “ignorant, unthinking or credulous” consumer, and second, whether the claim as so understood may fairly be said to constitute a representation that the product will affect the structure of the body in some medical-or drug-type fashion; i.e., in some way other than merely “altering the appearance.”
Two years later, the Magic Secret case was decided by the United States District Court for the District of Maryland. Like Line Away and Sudden Change, Magic Secret was a clear protein lotion intended to smooth facial wrinkles by forming an adhesive film which contracts as the liquid in the lotion evaporates. The court held, however, that the product, as advertised, was not a “drug” within the meaning of the FDCA, because the claims that it was a “pure protein” which causes an “astringent sensation,” were not “so extravagant and did not carry such drug connotation that a prospective purchaser, against background of constant exposure to puffing and extravagant claims with respect to cosmetics, would expect anything other than possibility that she might look better.”
Claims Evolve
How to make sense of these not entirely consistent opinions, then? The overall message of these three seminal cases is that cosmetic distributors must be wary of where the line is between cosmetic claims and drug claims, and statements that implicitly convey that a product is intended to function in a manner similar to a drug (as in the Line Away case) cross the line. However, as the holding of the Second Circuit in the Sudden Change case inherently recognizes, the standard for what constitutes a cosmetic claim is an evolving one.
As the Sudden Change court explained, “claims which have become so associated with the familiar exaggerations of cosmetics advertising that virtually everyone can be presumed to be capable of discounting them as puffery,” do not render a product a drug.9
Accordingly, while a claim of an astringent effect was thought in 1969 to reinforce a drug message, by 1971, it was considered to be essentially puffery. In the intervening decades, many of the factors that the court in the Line-Away case relied upon to establish that the product was a drug have become widely accepted as cosmetic claims. For example, the Line Away court was concerned that the advertising of the product conveyed that the product was intended as a drug because it “suggests that the lotion nourishes the skin.”10 However, nourishing the skin is, today, a common cosmetic claim that no one with even a passing familiarity with the industry or the regulatory scheme would suggest renders a face lotion a drug. Similarly, no one today would take the view that a claim that a product creates a tingling sensation or a claim that a product was packaged under aseptic conditions is evidence that the distributor intends the product to function as a drug. Indeed, the fact that the cosmetics marketplace is flooded with products bearing anti-aging, rejuvenating, line-reducing, firming, toning, brightening, and lifting claims speaks volumes about the types of claims that, even if they once might have been viewed otherwise, today have a firm and accepted place in the cosmetics aisle.
“But wait,” you may say. What about all of the Warning Letters that the FDA has issued to cosmetics companies? Don’t these letters constitute proof that a claim to remediate lines and wrinkles and other signs of aging are “drug claims”? The answer is no. It is true that in the late 1980s, the Agency did, in a series of Warning Letters and related follow-up correspondence, appear to embrace such an extremely restrictive view, stating that it considered claims that a product “will affect the body in some physiological way” to be drug claims, “even if the claim is that the effect is only temporary.” Therefore, the Agency asserted, most anti-aging and skin physiology claims would be considered to be drug claims. However, the FDA’s position at that time was not altogether consistent with legal precedent or Agency prior practice, and the FDA has not asserted such a restrictive position in the ensuing 30 years. Rather, both the FDA and the industry have interpreted the law in a more practical and intellectually honest manner, recognizing that not every claim that a product affects the structure or function of the skin renders the product a drug.
More specifically, claims that use terms like “anti-aging,” “regenerating” or “rejuvenating” in a manner that reasonably conveys simply that the product temporarily improves the appearance of aging skin or reduces fine lines or wrinkles, as well as claims that a product reduces the appearance of wrinkles, makes skin appear more plump, or improve the skin’s firmness or tonicity, are not typically regarded as drug claims unless accompanied by additional indicia that the distributor intends that a particular product be used to provide drug-like effects. In fact, we are aware of few, if any, instance in the past 25 year in which the Agency has objected to anti-aging claims unless the labeling or promotional materials for the product have also suggested or implied that the product could be used to increase collagen or elastin production, to provide or stimulate stem cells, blood circulation or angiogenesis, to treat or prevent skin diseases or disorders, to heal wounds, to reduce scarring or blemishes, to repair cellular or DNA damage, or to function as a substitute for facial surgery, injections or other FDA-approved skin treatments.
In short, and as the Second Circuit recognized nearly 50 years ago, the test of whether a skin care product is a cosmetic or a drug is not simply whether it is intended to have some effect on the structure of the skin. Rather, while claims concerning non-transient, non-trivial or therapeutic structural changes to the skin are drug claims, claims that are focused on transient or minor structural changes intended to enhance beauty are properly considered cosmetic claims. Moreover, the line between a “drug” claim and a “cosmetic” claim is not a static one, and many claims that may once upon a time have been viewed as drug claims are now acceptable in the cosmetics aisle. Against this backdrop, FDA’s withdrawal of the IA 66-38 may be seen as a simple recognition of the realities of the skin care marketplace in light of current state of anti-aging science and technology.
References
- In determining a product’s intended use, the FDA primarily refers to the labeling, advertising and other promotional claims made by its manufacturer or distributor. However, a product’s intended use may in some cases also be inferred from its composition or ingredients.
- 21 U.S.C. §§ 321(i) and (g).
- 21 U.S.C. § 321(i) (emphasis added).
- 21 U.S.C. § 321(g).
- See e.g., FDA, Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy Acids (“AHA Guidance”) (discussing without objection the use of widespread use of AHAs in cosmetics).
- See e.g., FDA’s webpage on “Hair Dyes.”
- See United States v. An Article ... ‘Line Away’ ..., 415 F.2d 369, 371-72 (3d Cir. 1969).
- See U.S. v. Article of Drug 47 Shipping Cartons, More or Less, “Helene Curtis Magic Secret,” 331 F.Supp. 912 (D. Md. 1971).
- Sudden Change, 409 F.2d at 741-42.
- See United States v. An Article ... ‘Line Away’ ..., 415 F.2d 369, 371-72 (3d Cir. 1969).
Georgia Ravitz is a partner in the firm’s Washington, DC, office and leads the Consumer Product Safety practice, and is a senior partner in the firm’s Food & Drug (FDA), Agriculture, and Advertising practices. She focuses on food and drug law and regulatory policy governing the regulation of a variety of categories, including cosmetics, health and beauty aids. Ravitz also focuses on the laws and regulations pertaining to consumer products generally, and those administered by the US Consumer Product Safety Commission (CPSC) and various state and local regulatory agencies responsible for consumer health and safety as well as the Federal Trade Commission (FTC).
Email: georgia.ravitz@arentfox.com
Naomi Halpern’s practice involves advising clients on a broad range of regulatory issues involving the Food and Drug Administration (FDA) with respect to pharmaceuticals (including branded, generic prescription, and over-the-counter drugs), medical devices, foods, cosmetics, and dietary supplements, as well as those involving oversight by the US Department of Agriculture (USDA) of food safety and labeling. She also advises on the laws and regulations relating to consumer products administered by the US Consumer Product Safety Commission (CPSC).
Email: naomi.halpern@arentfox.com
More info: Arent Fox, www.arentfox.com