To:
`Subject:
`Sent:
`Sent As:
`
`MINDI M. RICHTER(mrichter@shumaker.com)
`U.S. Trademark Application Serial No. 88588572 - BENEFICIAL BLENDS
`February 10, 2023 09:55:08 AM EST
`tmng.notices@uspto.gov
`
`Attachments
`
`screencapture-www-fda-gov-cosmetics-cosmetics-laws-regulations-it-cosmetic-drug-or-both-
`or-it-soap-16733892432221
`screencapture-www-fda-gov-inspections-compliance-enforcement-and-criminal-
`investigations-warning-letters-renas-organic-613036-02112022-16733908099091
`screencapture-www-fda-gov-inspections-compliance-enforcement-and-criminal-
`investigations-warning-letters-biomd-plus-llc-618460-05042022-16733908676891
`screencapture-www-fda-gov-inspections-compliance-enforcement-and-criminal-
`investigations-warning-letters-kingdom-harvest-625058-05042022-16733909016151
`screencapture-www-fda-gov-news-events-public-health-focus-fda-regulation-cannabis-and-
`cannabis-derived-products-including-cannabidiol-cbd-16734439211791
`screencapture-www-ahdictionary-com-word-search-html-16759827054571
`screencapture-chillaxn-com-products-premium-cbd-cream-16759827266951
`screencapture-chillaxn-com-products-premium-cbd-roll-on-cream-16760407041981
`
`United States Patent and Trademark Office (USPTO)
`Office Action (Official Letter) About Applicant’s Trademark Application
`
`U.S. Application Serial No.  88588572
`
`Mark:   BENEFICIAL BLENDS
`
`Correspondence Address:  
`Mindi M. Richter
`SHUMAKER, LOOP & KENDRICK, LLP
`101 E. KENNEDY BLVD., SUITE 2800
`TAMPA FL 33602 UNITED STATES
`
`Applicant:   Beneficial Blends LLC
`
`Reference/Docket No.  N/A
`
`Correspondence Email Address:   mrichter@shumaker.com
`
`
`
`
`
`
`REQUEST FOR RECONSIDERATION AFTER FINAL ACTION DENIED
`
`Issue date:   February 10, 2023
`
`Applicant’s request for reconsideration is denied.   See 37 C.F.R. §2.63(b)(3).  The trademark
`examining attorney has carefully reviewed applicant’s request and determined the request did not: (1)
`
`

`

`raise a new issue, (2) resolve all the outstanding issue(s), (3) provide any new or compelling evidence
`with regard to the outstanding issue(s), or (4) present analysis and arguments that were persuasive or
`shed new light on the outstanding issue(s).  TMEP §§715.03(a)(ii)(B), 715.04(a).  
`
`Accordingly, the following requirement(s) and/or refusal(s) made final in the Office action dated July
`18, 2022, are maintained and continued: 
`
`
`•
`
`•
`
`Section 1 and 45 Refusal – Unlawful Use of the Applied-For Mark in Commerce (FDCA
`Refusal)
`Specimen Refusal – Substitute Specimen Required
`
`
`See TMEP §§715.03(a)(ii)(B), 715.04(a).  
`
`If applicant has already filed an appeal with the Trademark Trial and Appeal Board, the Board will
`be notified to resume the appeal.   See TMEP §715.04(a).  
`
`If applicant has not filed an appeal and time remains in the response period for the final Office
`action, applicant has the remainder of that time to (1) file another request for reconsideration that
`complies with and/or overcomes any outstanding final requirement(s) and/or refusal(s), and/or (2) file a
`notice of appeal to the Board.  TMEP §715.03(a)(ii)(B).
`
`SECTION 1 AND 45 REFUSAL – UNLAWFUL USE OF THE APPLIED-FOR MARK IN
`COMMERCE (FDCA REFUSAL)
`
`Registration was previously refused because the applied-for mark was not in lawful use in commerce as
`of the filing date of the application. Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see
`TMEP §907. 
`
`To qualify for federal trademark/service mark registration, the use of a mark in commerce must be
`lawful.  Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir. 1987)
`(stating that “[a] valid application cannot be filed at all for registration of a mark without ‘lawful use in
`commerce’”); TMEP §907; see In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB 1968); Coahoma
`Chemical Co., Inc. v. Smith, 113 USPQ 413 (Com’r Pat. & Trademarks 1957) (concluding that “use of
`a mark in connection with unlawful shipments in interstate commerce is not use of a mark in commerce
`which the [Office] may recognize.”).  Thus, the goods and/or services to which the mark is applied
`must comply with all applicable federal laws.  See In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016)
`(citing In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993) (noting that “[i]t
`is settled that the Trademark Act’s requirement of ‘use in commerce,’ means a ‘lawful use in
`commerce’”)); In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976); TMEP §907. 
`
`Cannabidiol (CBD) is a chemical constituent of the cannabis plant.  On June 25, 2018, the U.S. Food
`and Drug Administration (FDA) approved the first prescription pharmaceutical formulation of plant-
`derived CBD, Epidiolex®, for the treatment of two rare forms of epilepsy, Lennox-Gastaut syndrome
`and Dravet syndrome.  The Drug Enforcement Administration (DEA) placed Epidiolex® on schedule
`V of the CSA on September 27, 2018.  Nevertheless, marijuana and CBD derived from marijuana
`remain unlawful.  No other cannabis-derived drug products have been approved by the FDA.  Under
`the FDCA, any product intended to have a therapeutic or medical use, and any product (other than a
`food) that is intended to affect the structure or function of the body of humans or animals, is a drug.  21
`U.S.C. § 321(g)(1). An unapproved new drug cannot be distributed or sold in interstate commerce
`
`

`

`unless it is the subject of an FDA-approved new drug application (NDA) or abbreviated new drug
`application (ANDA). 21 U.S.C. §§ 331(d) and 355(a), (b), & (j); see also FDA Regulation of Cannabis
`and Cannabis-Derived Products: Questions and Answers https://www.fda.gov/news-events/public-
`health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers
`copy
`previously attached.
`
`Here, the goods to which the proposed mark are applied are unlawful under the Food, Drug and
`Cosmetic Act (FDCA), 21 U.S.C. §321(g)(1). Though applicant identifies its goods as "Skin lotions
`and oils for cosmetic purposes; any CBD in the goods being solely derived from hemp with a delta-9
`tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis"
`evidence of record and the applicant's specimen contradict the cosmetic nature of this identification.
`
`Applicant concedes that its "products are for help in relieving tension and inflammation."
`
`The applicant then argues that its products are also for "better looking skin and are meant not for those
`who are sick or have a disease but rather for those with an athletic and/or active lifestyle. The goods at
`issue are very simply not a drug, and the FDA has made clear that topical products such as this helping
`inflammation caused by exercise or an active lifestyle are excepted from being defined as a drug and do
`not require FDA approval." The applicant provides additional arguments with attached evidence that
`the FDA does not regulate over the counter (OTC) products intended to be used as topical products for
`helping inflammation. 
`
`The applicant further argues "[t]he FDA, not the USPTO, is the government body that determines what
`products are considered drugs and/or for medical use such that they require FDA approval, and the
`FDA does not require approval for products like those of Applicant."
`
`These arguments have been considered and found unpersuasive.
`
`The FDA treats goods with CBD as an active ingredient differently from other drugs and OTC
`products. Specifically, any product intended to have a therapeutic or medicinal use containing CBD is
`considered a drug, and the FDA does not include CBD as an acceptable ingredient in OTC goods. "We
`are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses,
`and we have issued several warning letters to such firms. Under the FD&C Act, any product
`intended to have a therapeutic or medical use, and any product (other than a food) that is
`intended to affect the structure or function of the body of humans or animals, is a drug.  Drugs
`must generally either receive premarket approval by FDA through the New Drug Application (NDA)
`process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-
`
`Counter (OTC) Drug Review.   CBD was not an ingredient considered under the OTC drug review.  An unapproved new drug cannot be distributed or sold in interstate commerce." (emphasis added). See
`
`previously attached  FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and
`Answers. However, for applicant's convenience, the examining attorney has reattached the referenced
`FDA  webpage with  the referenced quotation highlighted. 
`
`The attached webpage from the FDA entitled "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?),"
`provides the difference between "cosmetics" and "drugs" as well as provides explanations on how to
`determine a products intended use. The following is an example provided by the FDA of determining
`intended use of a product, "a massage oil that is simply intended to lubricate the skin and impart
`fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle
`pain, it's a drug." See  attached website screenshots. As such, the manner in which the applicant's goods
`
`

`

`are advertised and marketed to consumers, such as stating "Oil up your achy joints for inst-ahhh relief;
`Rejuvenate with sooothing relaxation; Puts inflammation on notice so you can stay active;  Melt away
`soreness & tension" establishes that the goods are therapeutic in nature.  See  attached website
`screenshots from applicant’s website. 
`
`As discussed above the FDA treats products used for relieving pain and inflammation as therapeutic
`goods and as a drug. To further support this determination that topical products intended to relieve
`aches, pain, and inflammation are in violation of the FDCA, please see the attached FDA Warning
`Letters sent to Rena's Organic, BioMD Plus LLC, and Kingdom Harvest, which reference reviewing
`the applicant's website and marketing materials to determine the intended use of the associated
`products. The following excerpts from the attached warning letters have been provided (emphasis
`added):
`
`
`•
`
`The letter to Rena's Organic states: 
`
`
`
`
`
`
`
`This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your
`website at the Internet address www.renasorganic.com in February 2022 and has
`determined that you take orders there for the products...“500 mg Pain Relief Cream,”
`“1000 mg Pain Relief Cream,”...all of which you promote as products containing
`cannabidiol
`(CBD). We have also
`reviewed your social media websites at
`www.facebook.com/RenasOrganic and www.instagram.com/renasorganic; these websites
`direct consumers to your website, www.renasorganics.com to purchase your products. The
`claims on your website and social media websites establish that your...“500 mg Pain
`Relief Cream,” “1000 mg Pain Relief Cream,”...products are unapproved new
`drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and
`Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d)...“500 mg Pain Relief
`Cream” and “1000 mg Pain Relief Cream” are external analgesic drug products subject to
`section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs
`marketed without an approved application. Under section 505G of the FD&C Act, certain
`nonprescription drugs without an approved application —commonly referred to as "OTC
`monograph drugs"—may be legally marketed if they meet applicable requirements. In
`particular, topical products intended for use as an external analgesic are deemed to be
`GRASE and not a “new drug” if, among other things, they conform to the tentative final
`monograph (TFM) that is the most recently applicable proposal or determination for such
`drug issued under 21 CFR Part 330...However, your “500 mg Pain Relief Cream” and
`“1000 mg Pain Relief Cream” products do not conform to the conditions of use
`specified in the final administrative order, because the products’ active ingredient,
`CBD, is not an active ingredient in such order (nor in any applicable final monograph
`or TFM). (emphasis added).
`
`•
`
`The letter to BioMD states:
`
`This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed
`your website at www.biomdplus.com in February 2022 and has determined that you take
`orders there for various human and animal products, which you represent as containing
`cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC). We have also reviewed your
`social
`media
`websites
`at
`https://twitter.com/bioMDplus,
`and
`https://www.facebook.com/bioMDplus/
`https://www.instagram.com/biomdplus/,
`which direct consumers to your website www.biomdplus.com to purchase your products.
`
`

`

`The claims on your website and social media accounts establish that your products, some
`of which are available in multiple varieties...“CBD Pain Relief Cream,”...(hereinafter
`referred to as “your CBD and Delta-8 THC products for humans”) are unapproved new
`drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and
`Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d)...On your CBD Pain Relief
`Cream webpage: “bioMDplus Pain Cream in 500mg strength is a new formulated pain
`relief topical cream that made for use on sore muscle areas and areas where there is
`pain. bioMDplus Pain Cream infused with the Quality Full Spectrum CBD. bioMDplus
`CBD Cream provides effective, fast and long-lasting pain relief.”...Based on the above
`labeling claims, your CBD and Delta-8 THC products for human use are drugs. We are not
`aware of any adequate and well-controlled clinical trials in the published literature that
`support a determination that any of these products are generally recognized as safe and
`effective (GRASE) for use under the conditions prescribed, recommended or suggested in
`their labeling. Thus, your CBD and Delta-8 THC products for human use are “new drugs”
`within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p)...Even if your
`“CBD Pain Relief Cream” was considered a nonprescription drug, we note that a
`nonprescription drug product containing CBD cannot be legally marketed without an
`approved new drug application, regardless of whether the CBD is represented on the
`labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug
`has met applicable FDA requirements to be legally marketed for nonprescription use.
`Nonprescription drug products that include CBD as an active ingredient are not
`GRASE and are new drugs which require an approved application to be legally
`marketed. (emphasis added).
`
`
`
`
`
`•
`
`The letter to Kingdom Harvest states: 
`
`This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed
`your website at the Internet address www.kingdomharvest.com from October 2021 through
`April 2022 and has determined that you take orders there for various human and animal
`products, which you
`represent as containing cannabidiol
`(CBD) or Delta-8
`tetrahydrocannabinol (THC). We have also reviewed your social media websites at
`https://www.facebook.com/originalkingdomharvest/
`and
`https://www.instagram.com/kingdomharvest/?hl=en; which direct consumers to your
`website www.kingdomharvest.com to purchase your products. The claims on your website
`and social media accounts establish that your products, some of which are available in
`multiple varieties...“Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD &
`Menthol Pain Freeze Roll-On,”...(hereinafter referred to as “your CBD and Delta-8 THC
`products for humans”), are unapproved new drugs sold in violation of sections 505(a) and
`301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a)
`and 331(d)...Even if your “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD
`& Menthol Pain Freeze Roll-On,”...products were considered nonprescription drugs, we
`note that a nonprescription drug product containing CBD cannot be legally marketed
`without an approved new drug application, regardless of whether the CBD is represented
`on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-
`containing drug has met applicable FDA requirements to be legally marketed for
`nonprescription use. Nonprescription drug products that include CBD as an active
`ingredient are not GRASE and are new drugs which require an approved application to be
`legally marketed. CBD is not an active ingredient in any OTC monograph under section
`505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a
`
`

`

`nonprescription drug product, that product would still need an approved new drug
`application to be legally marketed, because the product would not meet the general
`requirements under section 505G of the FD&C Act under which certain
`nonprescription drug products may be marketed without an approved new drug
`application. In particular, such a product would not meet the general requirement with
`respect
`to
`the safety and suitability of
`inactive
`ingredients under 21 CFR
`330.1(e).(emphasis added).
`
`
`Lastly, the applicant argues that the applicant's specimen states "what's more, our topicals rejuvenate
`the skin, too." and that the applicant's goods are cosmetic in nature. To note the attached website
`screenshots from the applicant's website do not describe the products as being used to "rejuvenate the
`skin." Moreover, the applicant's website and specimen of use indicate that the identified good
`are intended to have a therapeutic use for the alleviation and treatment of inflammation and aches. It is
`this intended use which ultimately violates the FDCA, as explained in greater detail above with
`extensive examples from the FDA. The attached and referenced FDA warning letters establish that a
`review of an applicant's website and social media pages is a legitimate means  to determine an intended
`use of the associated goods. Ultimately, the conflict between the applicant's identification of with the
`applicant's website and specimen providing that the intended use is for therapeutic pain relief purposes,
`is the reason for the FDCA Refusal and Specimen Refusal. 
`
`New drugs may not be legally introduced or delivered for introduction into interstate commerce without
`prior approval from the FDA, as described in 21 U.S.C. §§331(d) and 355(a).   In order for an
`application to have a valid basis that could properly result in a registration, the use of the mark has to
`be lawful.  See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976).  The claimed use of the
`mark in commerce without FDA approval would be unlawful use in commerce.
`
`In the event applicant is currently seeking FDA approval of the marketing of its goods, applicant may
`submit a copy of its marketing application and amend the filing basis of the application to claim a bona
`fide intent to use the mark in commerce under Section 1(b), 15 U.S.C. §1051(b), until such time as
`applicant’s application is approved, and lawful use may be alleged.   See 37 C.F.R. §§2.34 et seq.,
`TMEP §§806 et seq.  Alternatively, applicant may respond to the stated refusal by submitting evidence
`and arguments against the refusal. 
`
`Ultimately, because the applicant's goods contain CBD the goods are treated differently from other
`OTC medicines by the FDA, which prohibits use of CBD in said goods. 
`
`For these reasons, the FDCA Refusal under Section 1 and 45 is now made FINAL. 
`
`SPECIMEN REFUSAL - DOES NOT SHOW USE WITH IDENTIFIED GOODS
`
`Applicant was previously refused registration in International Class 003 because the specimen of record
`did not show use with the identified non-medicated skincare products. Response options for
`overcoming that refusal, if any, were set forth in the prior Office action. Applicant responded by
`arguing against the specimen refusal; however, the arguments have been considered and found
`unpersuasive for the reasons immediately stated below.
`
`The applicant has applied-for the mark BENEFICIAL BLENDS for use in connection with "Skin
`lotions and oils for cosmetic purposes; any CBD in the goods being solely derived from hemp with a
`delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis"
`
`

`

`in International Class 003.
`
`The applicant's current specimen of record makes clear that the goods depicted therein are therapeutic
`or medicinal topical products, as explained in greater detail above. The TMEP states "[w]hen a
`specimen discloses that use of the identified goods is limited to a particular function or purpose,
`classification may be impacted." The TMEP goes on to provide the following example "orthopedic
`shoes are classified in Class 10 as medical apparatus, and ordinary shoes are classified in Class 25. If
`the specimen in an application for "shoes" in Class 25 shows that the goods are orthopedic shoes, the
`identification and classification must be amended to "orthopedic shoes" in Class 10."  See  TMEP
`§1401.07. Similar to the example provided in the TMEP, the specimen of use and attached website
`screenshots from applicant's website clearly establish that the goods are intended to be used for
`therapeutic or medicinal purposes to relieve inflammation and alleviate aches.
`
`Applicant argues the specimen of use does state "what's more, our topicals rejuvenate the skin, too."
`This phrase appears to convey an incidental benefit of the applicant's medicinal products rather than the
`intended use of applicant's goods. Moreover, "topicals" are defined as "Medicine Relating to, applied
`to, or affecting a localized area of the body, especially of the skin: a topical anesthetic." See  attached
`American Heritage Dictionary definition. Medicinal and therapeutic goods are properly classified in
`International Class 005 with "pharmaceuticals" rather than the current classification in International
`Class 003, which is intended for "cosmetics and cleaning preparations."  See  TMEP §1401.
`Accordingly, this refusal is made final because the specimen of record demonstrates use with goods in
`International Class 005 rather than the identified goods in International Class 003.
`
`Examples of specimens.  Specimens for goods include a photograph of (1) the actual goods bearing
`the mark; (2) an actual container, packaging, tag or label for the goods bearing the mark; or (3) a point-
`of-sale display showing the mark directly associated with the goods.  See 37 C.F.R. §2.56(b)(1), (c);
`TMEP §904.03(a)-(m).  A webpage specimen submitted as a display associated with the goods must
`show the mark in association with a picture or textual description of the goods and include information
`necessary for ordering the goods.  TMEP §904.03(i); see 37 C.F.R. §2.56(b)(1), (c). 
`
`Any webpage printout or screenshot submitted as a specimen must include the webpage’s URL and the
`date it was accessed or printed on the specimen itself, within the TEAS form that submits the specimen,
`or in a verified statement under 37 C.F.R. §2.20 or 28 U.S.C. §1746 in a later-filed response.  See 37
`C.F.R. §2.56(c); TMEP §§904.03(i), 1301.04(a).
`
`Response option. Applicant may respond to this refusal by submitting, for each applicable
`international class, a different specimen (a verified “substitute” specimen) that (a) was in actual use in
`commerce prior to the expiration of the deadline for filing the statement of use and (b) shows the mark
`in actual use in commerce for the goods and/or services identified in the statement of use. A “verified
`substitute specimen” is a specimen that is accompanied by the following statement made in a signed
`affidavit or supported by a declaration under 37 C.F.R. §2.20: “The substitute (or new, or originally
`submitted, if appropriate) specimen(s) was/were in use in commerce prior to expiration of the filing
`deadline for filing a statement of use.” The substitute specimen cannot be accepted without this
`statement.
`
`Applicant may not withdraw the statement of use. See 37 C.F.R. §2.88(f); TMEP §1109.17.
`
`For an overview of this response option and instructions on how to submit a different specimen using
`the online Trademark Electronic Application System (TEAS) form, see the Specimen webpage.
`
`

`

`
`COMMENTS
`
`Applicant may call or email the assigned trademark examining attorney with questions about this
`Office action.  Although an examining attorney cannot provide legal advice, the examining attorney can
`provide additional explanation about the refusal(s) and/or requirement(s) in this Office action.  See
`TMEP §§705.02, 709.06. 
`
`The USPTO does not accept emails as responses to Office actions; however, emails can be used for
`informal communications and are included in the application record.  See 37 C.F.R. §§2.62(c), 2.191;
`TMEP §§304.01-.02, 709.04-.05. 
`
`How to respond.   File a request form for reconsideration of this final Office action that fully
`resolves all outstanding requirements and/or refusals and/or file a timely appeal form to the
`Trademark Trial and Appeal Board with the required fee(s).  Alternatively, applicant may file a
`request form for an extension of time to file a response for a fee.  
`
`
`/Andrew Clark/
`Trademark Examining Attorney
`Law Office 107
`(571) 270-7304
`Andrew.Clark@USPTO.GOV
`
`
`
`

`

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`Whethera productis a cosmetic or a drug underthe lawis determined bya product's
`intendeduse.Different laws and regulations applyto each typeof product. Firms
`sometimesviolate the law by marketing a cosmetic with a drug claim or by marketing a
`drug asif it were a cosmetic, without adhering to requirements for drugs.
`Howdoesthe lawdefine a cosmetic?
`Howdoesthe lawdefine a drug?
`Howcan a product be both a cosmetic and a drug?
`¢ Whatabout"cosmeceuticals"
`Howis a product's intendeduse established?
` rentfe
`Howarethe laws and regulations
`Howare approvalrequirementsdifferent?
`Whatdo these terms mean?
`e Howare good manufacturingpractice requirementsdifferent?”
`
`cosmetics and drugs?
`
`

`

`« Howareregistration requirementsdifferent?
`Howare labelingrequirementsdifferent?"
`« And whatifit's "soap"?
`* Howdoes FDA define "soap"?
`.
`nser
`m
`« More resources
`Howdoesthe law define a cosmetic?
`
`criteria...
`
`The Federal Food,Drug, and Cosmetic Act (FD&C Act) defines cosmetics bytheir intended
`use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introducedinto,
`or otherwise applied to the humanbody...for cleansing, beautifying, promoting
`attractiveness, oraltering the appearance" [FD&CAct, sec. 201(i)]. Amongthe products
`includedin this definition are skin moisturizers, perfumes,lipsticks, fingernail polishes,
`eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors,
`and deodorants, as well as any substance intended for use as a componentof a cosmetic
`product.
`Howdoesthe law define a drug?
`The FD&C Act defines drugs,in part, bytheir intended use,as "articles intended for use in
`the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other
`than food) intendedto affect the structure or anyfunction ofthe bodyof manor other
`animals" [FD&C Act, sec. 201(g)(1)].
`back to top
`Howcana product be both a cosmetic and a drug?
`Someproducts meetthe definitions of both cosmetics and drugs. This may happen when a
`producthas two intendeduses. For example, a shampoois a cosmetic becauseits intended
`use is to cleanse the hair. An antidandruff treatmentis a drug becauseits intendeduseis
`to treat dandruff. Consequently, an antidandruff shampoois both a cosmetic and a drug.
`Amongother cosmetic/drug combinations are toothpastes that contain fluoride,
`deodorantsthat are also antiperspirants, and moisturizers and makeup marketed with
`sun-protection claims. Such products must complywith the requirements for both
`cosmetics and drugs.
`What about "cosmeceuticals"?
`
`The FD&C Act does not recognize anysuch categoryas "cosmeceuticals." A product can be
`a drug, a cosmetic, or a combination ofboth, but the term "cosmeceutical” has no meaning
`underthe law.
`
`Howis a product's intendeduse established?
`Intended use maybe established in a numberofways. Thefollowing are some examples:
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`¢ Claimsstated on the product labeling, in advertising, on the Internet, or in other
`promotional materials. Certain claims maycausea product to be considereda drug,
`even if the product is marketed asifit were a cosmetic. Such claims establish the
`productas a drug because the intended useis to treat or prevent disease or otherwise
`affect the structure or functions ofthe human body. Some examples are claims that
`products will restore hair growth, reduce cellulite, treat varicose veins, increase or
`decrease the productionof melanin (pigment) in the skin, or regenerate cells.
`e Consumerperception, which maybe established through the product's reputation.
`This means asking whythe consumeris buying it and what the consumer expectsit to
`do.
`« Ingredients that cause a product to be considered a drug because theyhave a well-
`known(to the public and industry) therapeutic use. An exampleis fluoride in
`toothpaste.
`This principle also holds truefor "essentialoils." For example, a fragrance marketed for
`promotingattractiveness is a cosmetic. But a fragrance marketed with certain
`"aromatherapy"claims, such as assertions that the scentwill help the consumersleep or
`quit smoking, meets the definition of a drug becauseofits intendeduse. Similarly, a
`massageoil that is simply intendedto lubricate the skin and impart fragrance is a
`cosmetic, butif the product is intended for a therapeutic use, such as relieving muscle
`aid, it's a drug.
`back to top
`Howare the laws and regulations different for cosmetics and drugs?
`Thefollowing information is not a complete treatmentofcosmetic or drug laws and
`regulations.It is intended only to alert you to some important differences between the
`laws and regulations for cosmetics and drugsin the areas of approval, good manufacturing
`practice, registration, and labeling. Questions regarding lawsandregulations for drugs
`should be directed to FDA's Center for Drug Evaluation and Research (CDER).
`Howare approval requirements different?
`Underthe FD&C Act, cosmetic products and ingredients, with the exception of color
`additives, do not require FDA approvalbefore theygo on the market. Drugs, however,
`must generallyeither receive premarket approval by FDA through the New Drug
`Application (NDA) process or conform to a "monograph"for a particular drug category, as
`established by FDA's Over-the-Counter (OTC) Drug Review. These monographsspecify
`conditions whereby OTC drug ingredients are generally recognized as safe andeffective,
`and not misbranded. Certain OTC drugs may remain onthe market without an NDA.
`approval until a monographforits class of drugsis finalized as a regulation. However,
`once FDA has madea final determination on the status of an OTC drug category, such
`products musteither be the subject ofan approved NDA [FD&CAct,sec. 505(a) and (b)],
`or complywith the appropriate monographfor an OTC drug. (A note on the term
`"new drug”: Despite the word "new," a "new drug" mayhave been in use for many years.
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`it a productis intendedtor use as a drug, it must complywith the requirements outlined
`above.)
`Whatdo these terms mean?
`
`e An NDAisthe vehicle through which drug sponsors formally propose that FDA
`approve a pharmaceutical for sale and marketingin the United States. FDA only
`approves an NDAafter determining, for example, that the data is adequate to show
`the drug's safety andeffectiveness for its proposeduse andthatits benefits outweigh
`the risks. The NDAsystem is also usedfor newingredients and