Medical device vs. cosmetics: a question of FDA regulation

The federal Food Drug & Cosmetic Act distinguishes medical devices from cosmetics, though I've come across a letter debating the FDA's warning that a certain cosmetic could constitute a "medical device."

Below are excerpts from Salton, arguing that a beauty cream should not be considered a "device" simply because it is intended to help smoothe wrinkles.

On behalf of Salton, Inc., ("Salton"), this responds to your letter of July 12, 2000 in which you comment upon the status of Salton's Rejuvenique Facial Toning System ("Rejuvenique") and express the view that you consider it to be a medical device, even absent medical or therapeutic claims, because it affects the structure or function of the body. As discussed in detail below, we respectfully disagree with the FDA's conclusion that the Rejuvenique product or its components are properly subject to regulation as a "medical device".

The Rejuvenique Facial Toning System has the legal status of a cosmetic appliance and is labeled and promoted wholly within the concepts legally applicable to such products. Rejuvenique is not a medical device because it is intended only for beautifying, promoting the attractiveness, and temporarily altering the appearance of the face and skin. It is not intended for medical or therapeutic uses. Moreover, the effects associated with its use are transitory and innocuous. Under FDA's governing statute and implementing regulations, Rejuvenique should be treated no differently than razor blades, manicuring instruments, nail extenders, depilatories, hair curlers, hair dryers, hair straighteners, exercise equipment, electric razors, facial steamers, hot tubs -- that is, as ordinarily represented and unless medical claims are made for these products, they are either cosmetic appliances or consumer products and are not subject to regulation by FDA as medical devices.

The Warning Letter states FDA's conclusion that:

Under a United States Federal Law, the Federal Food, Drug and Cosmetic Act, Rejuvenique is considered to be a medical device because it is intended to affect the structure or function of the body. . . . Also, because Rejuvenique is intended to affect the structure and function of the body by providing electrical current to various facial muscles to repeatedly contract them, it is a device, even if no claims are made for its specific use....

Under the Federal Food, Drug, and Cosmetic Act (the "FD&C Act"), a device is defined, in relevant part, as "an instrument, apparatus, implement, machine . . . which is -(1) . . .

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals . . . .

Section 201(h) of the FD&C Act, 21 U.S.C. § 321 (h).

The language "intended to affect the structure or any function of the body" must be read in the context of the Congressional regulation of foods, drugs, cosmetics, and medical devices, as established in the FD&C Act. Clearly if that language is read literally, almost every product that is intended to temporarily improve the appearance of skin would be a medical device (or drug) because the only way to improve the appearance of skin is to affect the skin's "structure." All cosmetics, including even color cosmetics, affect the structure of the skin at some level. Therefore, under a literal interpretation of the medical device definition, all cosmetic products should be regulated as medical devices (or as "drugs" under the analogous definition of "drug" which contains the same structure/function language).

The definitional difference between a cosmetic and a device under Sections 201(h) and (i) of the FD&C Act rests upon the "intended" use of the article. The legislative history makes clear that it is the representations that are made for an article that will determine its proper regulatory classification:

The use to which the product is to be put will determine the category into which it will fall....The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put.

S.Rep.No. 361, 74th Cong., 1st Sess. 4 (1935). For example, in cases in which the distinction between a cosmetic and a drug was in contention, the courts have uniformly looked to the labeling and advertising of a product to determine the "intended" use. United States v. An Article ...Sudden Change, 409 F.2d 734, 739-742 (2d Cir. 1969); United States v. An Article ..."Line Away", 415 F.2d 369, 371-372 (3rd Cir. 1969). In National Nutritional Foods Association v. Mathews, 557 F.2d 325, 333-336 (2d Cir. 1977), the court held that FDA could not subject dietary supplements containing high levels of vitamin A and D to regulation as drugs merely because those high levels have a "drug" effect, unless it could also identify labeling claims or other evidence to show that these products were "intended" to function as drugs.

In the Preamble to the Final Rule classifying physical medicine devices (including "powered muscle stimulators"), FDA stated:

FDA will determine the intended use of a product based upon the expressions of the person legally responsible for its labeling and by the circumstances surrounding its distribution. The most important factors the agency will consider in determining the intended use of a particular product are the labeling, advertising, and other representations accompanying the product. Products that have medical uses only are clearly intended for medical purposes and, therefore, will be regulated as medical devices whether or not medical claims are made for them. Examples of claims relevant to physical medicine devices that would cause a product to be considered a device include, but are not limited to, claims relating to the following: Re-education, correction, improvement, or maintenance of bodily functions impaired by abnormal bodily states or physiologic functions. Examples of abnormal bodily states or physiologic functions include, but are not limited to, the following: (1) Neuromuscular disorders (such as stroke, muscular dystrophy, multiple sclerosis, and cerebral palsy); (2) limb amputations; and (3) musculoskeletal disorders (such as arthritis, tendonitis, fractures, and low back pain). FDA has changed the regulations classifying many physical medicine devices to clarify that the regulations only apply to those products intended for medical purposes.[1]

Again, FDA makes clear that the intended use of an item is inferred from the representations and labeling associated with the product. Salton makes no medical device claims for Rejuvenique.

Clearly, Congress did not intend that the "structure/function" provision of the medical device (or drug) definition be read literally, and, obviously, FDA typically has not done so in the past. Applying the structure/function provision literally would mean that countless products on the market today would be classified as medical devices subject to FDA jurisdiction. Some products that are intended to affect the structure or function of the body, such as high heeled shoes (structure of the leg), alarm clocks (function of sleep), stereos (function of sound) and even guns (structure and function of the body), have no medical uses and, therefore, FDA simply does not regulate them.

FDA's regulation of cosmetics and drugs provides support for the position that the structure/function provisions of the FD&C Act cannot be applied literally and that a product's regulatory status should be based on claims made for the product. As the Agency knows, the definition of "drug" under the FD&C Act also has a structure/function provision. Section 201(g)(i) of the FD&C Act, 21 U.S.C. § 321(g)(1). The FD&C Act defines cosmetics as:

articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.

As noted above, taken literally, all cosmetic products could be regulated as drugs or devices under the structure/function definition. Even moisturizers penetrate the skin and cause it to "plump," thus affecting the skin's structure. Exfoliating agents, such as alpha hydroxy acids, are commonly used in cosmetics to exfoliate skin cells. Other common cosmetic ingredients, such as zinc, urea, certain amino acids, and manganese, also exert various "physiological" effects below the stratum corneum which produce cosmetic benefits.[2] Therefore, applying the structure/function provision literally would lead to the impractical result that all of these products would be regulated as drugs.

Not only is a literal interpretation of the structure/function provision unworkable, but its application is contrary to Congressional intent. In expanding the FD&C Act's definition of drugs to include an "article intended to affect the structure or any function of the body," Congress was aware that the broad new provision could include some articles that also might fall within other definitions under the FD&C Act. [3] Yet, this does not mean that Congress meant the drug definition to encompass any article having some structural or functional effect on the body. The "structure or function" aspect of the definition was an amplification of the word "disease," not an effort to reach any product that touches the body.

It is clear from the cosmetic definition itself that Congress contemplated regulating as "cosmetics" articles "introduced into" the body, even though such an article could only achieve its intended cosmetic purpose by affecting the structure or function of the body in some way. Indeed, the definition was intentionally "drawn in broad terms to include all substances . . . intended for cleansing, or altering the appearance of, or promoting the attractiveness of the person" whether "used externally, orificially, or even internally, as in the case of the use of arsenic for clearing the complexion."[4] Further, specific legislative references to wrinkle remedies and other skin care products indicate that they have consistently been viewed by Congress as cosmetics, and not as drugs or devices.[5]

In considering whether cosmetic products should be regulated as drugs on the basis of labeling and advertising claims, Courts have refused to adopt such a "broad reading of the definition of drug" that "any claim of physical change or effect makes [an] . . . article a drug."[6] The essential question, rather, is whether the claims "may fairly be said to constitute a representation that the product[s] 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."[7]

The letter is rather long and goes into a line of cases in which the FDA tried to distinguish "drugs" from "cosmetics." The point is that "courts have refused to construe the FD&C Act's definitions so broadly that other definitional categories would be subsumed or made meaningless." The problem really stems from the 'epistemological chaos' of the Act itself in setting up these different regulatory boxes -- i.e., device, drug, cosmetic -- and making them turn in large part on something as nebulous as 'intended use,' which can have subjective as well as objective components.

In fact, Salton's 2000 letter is particularly interesting in light of the recent FDA guidance on complementary and alternative medicine, which has generated much controversy. Salton notes that "there are other products that we refer to as "dual use" products, which incidentally affect the structure or function of the body and have both appropriate medical and non-medical uses. Dual use products include such things as exercise equipment, massagers, light bulbs, beds, steam rooms, hot tubs, support stockings, athletic supporters, razor blades, manicure instruments, and vibrators. Clearly, in the absence of medical claims, none of these products should be, or are, considered a 'medical device.'"

Indeed, such consumer products would not be regulated under the medical device label, and some CAM products would include products within this list. The site goes on to note that the FDA only regulates where these products are intended to be used as medical devices. That intention refers to the manufacturer's promotional efforts, once again creating a nebulous regulatory environment in which the marketing concept dictates the regulatory box and level of scrutiny.

By way of contrast, the Massachusetts Board of Registration in Medicine has posted draft minutes from a meeting from its medical spa task force. Those minutes, reproduced below, highlight similar epistemological chaos when it comes to trying to understand the interplay between the FDA role and the Board's role. The language gets especially confusing when the Board says that the FDA "supercedes the work of the state," which is not entirely accurate.

. Welcome, Goals for Today's Discussion Nancy Achin Audesse, Executive Director of the Board of Registration in Medicine, welcomed the group to the second meeting of the Medical Spa Task Force. Participants once again introduced themselves, as did the guests sitting in on the meeting.

The first issue of business was the approval of the draft minutes, which had been emailed to task force members for review. Ms. Achin Audesse made a motion to approve the minutes, Senator Menard approved the motion, and Mr. Chisari seconded. Next, Ms. Achin Audesse directed the group's attention to an email sent by Paul Dryer, Director of the Division of Health Care Quality at the Department of Public Health, and her response. Though Mr. Dryer was appreciative of Ms. Achin Audesse's input, he declined to delay posting the DPH's policy on Medical Spas on the DPH website until the work of this task force is complete. Ms. Achin Audesse reassured the group that this decision does not depreciate their work; rather, any recommendations the group makes will, if necessary, result in statutory change in order to correct identified issues. Ms. Achin Audesse explained that the focus of this meeting will be on the first of the three questions facing the group, defined at the first meeting: what procedures will be considered, who will perform the procedures, and where the procedures will take place.The goal of the meeting is to define categories of procedures in order to define the "what" of the task force's work in order to move forward with a shared understanding. 2. Medical Spa Association Glossary of Terms -- Handout Ms. Achin Audesse thanked Ms. Bernstein for suggesting this list as a launching pad for the group's discussion on the definition of medical spa procedures. Ms. Bernstein noted that a far longer list is available, containing information on a wider variety of alternative therapies than is presented here, and Mr. Aims volunteered to email the link to this longer list to all participants. Ms. Achin Audesse then encouraged the group to offer their own suggestions, since one of the end products of this undertaking will be the group's ownglossary of all the terms used in the final report. After reviewing the glossary, several members offered their comments and criticisms. Ms. Jenkins stated that many of the definitions in this glossary do not reflect what theyare actually trying to define. For example, the definition of "laser resurfacing" does not distinguish between ablative (a process that disrupts tissue) and non-ablative (a process that does not disrupt tissue) resurfacing treatments. Distinctions like this are crucial, and the group must carefully consider the semantics of all terms used to prevent gaps such as this. Agreeing with Ms. Jenkin's assessment, Dr. Dover noted that this glossary was obviously written from an aesthetician's point of view. He argued that the document is too misleading to use as a basis for the group's own document. In light of these comments, Ms. Achin Audesse asked whether the members of the task force could, based on their extensive knowledge and experience, submit glossary terms on procedures, along with their links, to the task force website. The group agreed
unanimously with this idea. Ms. Hinds and Dr. Dover offered to lead this work, and Dr. Quibell offered her help as well, noting that it is important that the glossary be forward-thinking. Mr. Aims will structure the resulting information and make it available in two weeks (December 27, 2006). 3. The "What": Procedures with which the Task Force should be concerned After some discussion as to how to organize the procedures to be considered, the group agreed that, in addition to a glossary containing all the relevant terms, the report could categorize the terms into groups. The task force agreed on the idea that the procedures will be most usefully categorized by delivery method. The group also agreed that all trade terms, such as Botox®, be removed from the glossary. Additionally, laser eye surgery will not be considered a medical spa procedure. The subcategory for organization will be treatment targets, rather than the devices used to provide the treatments. Ms. Achin Audesse noted that the FDA has been contacted, so the group can see where they stand on the procedures discussed and how the FDA groups and understands them. Though the following list will certainly not be exhaustive, it will identify some of the procedures on which the group will work. Additionally, it will give a sense of the order in which to look at the procedures. Considering this list, Ms. Jenkins expressed concern that the statute for this task force grouped laser / light procedures with radiofrequency procedures, when the mechanisms of the two are completely different. She worried that the end product may end up with procedures may end up grouped inappropriately. Senator Menard replied that the statute can certainly be changed according to suggestions like this; statutes are created in light of the opinions of experts, such as those gathered here. The task force members agreed with this suggestion, and Dr. Dover further suggested that the categories above can be further defined and sub-categorized as the group continues its work.

•FDA Definition & Rules •Other Current Regulatory Definitions •Identify Treatment Targets *Hair Removal*Vascular *Pigmentation, including Tattoo Removal*Wrinkles *Scars & Stretch Marks *Acne *Fat & Cellulite, including Skin Tightening*Miscellaneous RADIOFREQUENCY DEVICES OTHER ENERGY SOURCES COMBINATION MODALITIES INJECTABLESNEUROMODULATORS (Botulinum exotoxins) TISSUE FILLERS SCLEROTHERAPY MESOTHERAPYOTHER TISSUE ALTERATIONMECHANICAL (Superficial, Medium, Deep) CHEMICAL(Superficial, Medium, Deep) CRYOTHERAPY ELECTROCAUTERY OTHER SURGICAL INTERVENTIONS
FACE LIFTS EYE LIFTS LIPOSUCTIONHAIR TRANSPLANTATION OTHER After agreeing on this provisional list of delivery methods, discussion moved to the question of how this task force could give advice to practitioners on how they should make decisions as to the safety and reliability of a substance or treatment when new things come out on the market. Ms. Achin Audesse wondered if there is a benchmark for product safety and reliability, and what role the FDA plays in determinations of safety. Dr. Dover answered that, at the present time, the FDA plays this regulatory role. However, the FDA regulates companies only, that is, determines what devices and products can be sold. Therefore the FDA's work supercedes the work of the state. The task force should be clear on the fact that, in the Commonwealth of Massachusetts, practitioners only use devices that are FDA-approved. Any practitioners who imports and uses devices that are not FDA-approved, such as mesotherapy, are breaking the law. Another issue related to FDA approval is the off-label use of approved products. Ms. Hinds offered the example of Botox®, which was only approved for cosmetic purposes in 2002, had been used for such purposes since approximately 1992. Dr. Dover noted that good practice requires that the practitioner informs the patient that the use in question is an off-label use (for example, the use of tetracycline to treat acne). However, as Ms. Achin Audesse explained, off-label use is not necessarily a bad practice. Often companies do not have the money or time to bring an already-approved drug back to the FDA in order to obtain approval for additional uses. It is also far easier to get a drug approved by the FDA for one use, rather than multiple applications. Ms. Kellman also stressed the point that the first test the FDA runs tests the safety of a product, so there is a baseline of safety for all drugs on the market. Because of this safety provision, there is an exception in FDA law that allows for off-label usage. 4. Next Steps and Quions Ms. Achin Audesse summarized the tasks facing the task force. Mr. Aims will post the list of delivery method groups on the website, and participants can email with their input and suggestions. All participants agreed to take an active role in working on this list of definitions and categorizations. The forum was then opened for visitor comments. Ms. Michelle Saber asked if the group intended to recommend regulations covering each procedure discussed in minute detail.

Many spas have a wellness orientation but no MD and do not style themselves as medical spas, and would probably not come under the medical board's purview at all, whereas others will need to look at statutory supervision requirements relative to non-medical providers and various therapies.