§ 710.8
`
`§ 710.8 Misbranding by reference to
`registration or to registration num-
`ber.
`Registration of a cosmetic product
`establishment or assignment of a reg-
`istration number does not in any way
`denote approval of the firm or its prod-
`ucts by the Food and Drug Administra-
`tion. Any representation in labeling or
`advertising that creates an impression
`of official approval because of registra-
`tion or possession of a registration
`number will be considered misleading.
`
`§ 710.9 Exemptions.
`The following classes of persons are
`not requested to register in accordance
`with this part 710 because the Commis-
`sioner has found that such registration
`is not justified:
`(a) Beauty shops, cosmetologists, re-
`tailers, pharmacies, and other persons
`and organizations that compound cos-
`metic products at a single location and
`administer, dispense, or distribute
`them at retail from that location and
`who do not otherwise manufacture or
`package cosmetic products at that lo-
`cation.
`(b) Physicians, hospitals, clinics, and
`public health agencies.
`(c) Persons who manufacture, pre-
`pare, compound, or process cosmetic
`products solely for use in research,
`pilot plant production, teaching, or
`chemical analysis, and who do not sell
`these products.
`
`PART 720—VOLUNTARY FILING OF
`COSMETIC
`PRODUCT
`INGRE-
`DIENT COMPOSITION
`STATE-
`MENTS
`
`Sec.
`720.1 Who should file.
`720.2 Times for filing.
`720.3 How and where to file.
`720.4
`Information requested about cosmetic
`products.
`720.5
`[Reserved]
`720.6 Amendments to statement.
`720.7 Notification of person submitting cos-
`metic product ingredient statement.
`720.8 Confidentiality of statements.
`720.9 Misbranding by reference to filing or
`to statement number.
`
`AUTHORITY: 21 U.S.C. 321, 331, 361, 362, 371,
`374.
`
`21 CFR Ch. I (4–1–12 Edition)
`
`SOURCE: 39 FR 10060, Mar. 15, 1974, unless
`otherwise noted.
`
`§ 720.1 Who should file.
`Either the manufacturer, packer, or
`distributor of a cosmetic product is re-
`quested to file Form FDA 2512 (‘‘Cos-
`metic Product Ingredient Statement’’),
`whether or not the cosmetic product
`enters interstate commerce. This re-
`quest extends to any foreign manufac-
`turer, packer, or distributor of a cos-
`metic product exported for sale in any
`State as defined in section 201(a)(1) of
`the Federal Food, Drug, and Cosmetic
`Act. No filing fee is required.
`
`[57 FR 3129, Jan. 28, 1992]
`
`§ 720.2 Times for filing.
`Within 180 days after forms are made
`available to the industry, Form FDA
`2512 should be filed for each cosmetic
`product being commercially distrib-
`uted as of the effective date of this
`part. Form FDA 2512 should be filed
`within 60 days after the beginning of
`commercial distribution of any product
`not covered within the 180-day period.
`
`[57 FR 3129, Jan. 28, 1992]
`
`§ 720.3 How and where to file.
`Forms FDA 2512 and FDA 2514 (‘‘Dis-
`continuance of Commercial Distribu-
`tion of Cosmetic Product Formula-
`tion’’) are obtainable on request from
`the Food and Drug Administration,
`5100 Paint Branch Pkwy., College Park,
`MD 20740, or at any Food and Drug Ad-
`ministration district office. The com-
`pleted form should be mailed or deliv-
`ered to: Cosmetic Product Statement,
`Food and Drug Administration, 5100
`Paint Branch Pkwy., College Park, MD
`20740, according to the instructions
`provided with the forms.
`
`[57 FR 3129, Jan. 28, 1992, as amended at 68
`FR 15355, Mar. 31, 2003]
`
`§ 720.4 Information requested about
`cosmetic products.
`(a) Form FDA–2512 requests informa-
`tion on:
`(1) The name and address, including
`post office ZIP code of the person
`(manufacturer, packer, or distributor)
`designated on the label of the product.
`
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`Petitioner Dr. Squatch
` Ex. 1046
`
`

`

`Food and Drug Administration, HHS
`
`(2) The name and address, including
`post office ZIP code, of the manufac-
`turer or packer of the product if dif-
`ferent from the person designated on
`the label of the product, when the man-
`ufacturer or packer submits the infor-
`mation requested under this paragraph.
`(3) The brand name or names of the
`cosmetic product.
`(4) The cosmetic product category or
`categories.
`(5) The ingredients in the product.
`(b) The person filing Form FDA–2512
`should:
`(1) Provide the information requested
`in paragraph (a) of this section.
`(2) Have the form signed by an au-
`thorized individual.
`(3) Provide poison control centers
`with
`ingredient
`information and/or
`adequate diagnostic and therapeutic
`procedures to permit rapid evaluation
`and treatment of accidental ingestion
`or other accidental use of the cosmetic
`product.
`(4) Provide ingredient information
`(and, when requested, ingredient sam-
`ples) to a licensed physician who, in
`connection with the treatment of a pa-
`tient, requests assistance in deter-
`mining whether an ingredient in the
`cosmetic product is the cause of the
`problem for which the patient is being
`treated.
`(c) One or more of the following cos-
`metic product categories should be
`cited to indicate the product’s intended
`use.
`(1) Baby products. (i) Baby shampoos.
`(ii) Lotions, oils, powders, and
`creams.
`(iii) Other baby products.
`(2) Bath preparations. (i) Bath oils,
`tablets, and salts.
`(ii) Bubble baths.
`(iii) Bath capsules.
`(iv) Other bath preparations.
`(3) Eye makeup preparations. (i) Eye-
`brow pencil.
`(ii) Eyeliner.
`(iii) Eye shadow.
`(iv) Eye lotion.
`(v) Eye makeup remover.
`(vi) Mascara.
`(vii) Other eye makeup preparations.
`(4) Fragrance preparations. (i) Co-
`lognes and toilet waters.
`(ii) Perfumes.
`
`§ 720.4
`
`(i)
`
`(iii) Powders (dusting and talcum)
`(excluding aftershave talc).
`(iv) Sachets.
`(v) Other fragrance preparations.
`(5) Hair preparations (noncoloring). (i)
`Hair conditioners.
`(ii) Hair sprays (aerosol fixatives).
`(iii) Hair straighteners.
`(iv) Permanent waves.
`(v) Rinses (noncoloring).
`(vi) Shampoos (noncoloring).
`(vii) Tonics, dressings, and other hair
`grooming aids.
`(viii) Wave sets.
`(ix) Other hair preparations.
`(6) Hair coloring preparations. (i) Hair
`dyes and colors (all types requiring
`caution statement and patch test).
`(ii) Hair tints.
`(iii) Hair rinses (coloring).
`(iv) Hair shampoos (coloring).
`(v) Hair color sprays (aerosol).
`(vi) Hair lighteners with color.
`(vii) Hair bleaches.
`(viii) Other hair coloring prepara-
`tions.
`(7) Makeup preparations (not eye). (i)
`Blushers (all types).
`(ii) Face powders.
`(iii) Foundations.
`(iv) Leg and body paints.
`(v) Lipstick.
`(vi) Makeup bases.
`(vii) Rouges.
`(viii) Makeup fixatives.
`(ix) Other makeup preparations.
`(8) Manicuring
`preparations.
`Basecoats and undercoats.
`(ii) Cuticle softeners.
`(iii) Nail creams and lotions.
`(iv) Nail extenders.
`(v) Nail polish and enamel.
`(vi) Nail polish and enamel removers.
`(vii) Other manicuring preparations.
`(i)
`(9) Oral
`hygiene
`products.
`Dentifrices (aerosol, liquid, pastes, and
`powders).
`(ii) Mouthwashes and breath fresh-
`eners (liquids and sprays).
`(iii) Other oral hygiene products.
`(10) Personal cleanliness. (i) Bath
`soaps and detergents.
`(ii) Deodorants (underarm).
`(iii) Douches.
`(iv) Feminine hygiene deodorants.
`(v) Other personal cleanliness prod-
`ucts.
`(11)
`Shaving
`Aftershave lotions.
`
`preparations.
`
`(i)
`
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`

`

`§ 720.5
`
`(ii) Beard softeners.
`(iii) Men’s talcum.
`(iv) Preshave lotions (all types).
`(v)
`Shaving
`cream
`(aerosol,
`brushless, and lather).
`(vi) Shaving soap (cakes, sticks,
`etc.).
`(vii) Other shaving preparation prod-
`ucts.
`(12) Skin care preparations, (creams, lo-
`tions, powder, and sprays). (i) Cleansing
`(cold creams, cleansing lotions, liquids,
`and pads).
`(ii) Depilatories.
`(iii) Face and neck (excluding shav-
`ing preparations).
`(iv) Body and hand (excluding shav-
`ing preparations).
`(v) Foot powders and sprays.
`(vi) Moisturizing.
`(vii) Night.
`(viii) Paste masks (mud packs).
`(ix) Skin fresheners.
`(x) Other skin care preparations.
`(13) Suntan preparations. (i) Suntan
`gels, creams, and liquids.
`(ii) Indoor tanning preparations.
`(iii) Other suntan preparations.
`(d) Ingredients in the product should
`be listed as follows:
`(1) A list of each ingredient of the
`cosmetic product in descending order
`of predominance by weight (except that
`the fragrance and/or flavor may be des-
`ignated as such without naming each
`individual ingredient when the manu-
`facturer or supplier of the fragrance
`and/or flavor refuses to disclose ingre-
`dient data).
`(2) An ingredient should be listed by
`the name adopted by the Food and
`Drug Administration (FDA) for the in-
`gredient pursuant to § 701.3(c) of this
`chapter.
`(3) In the absence of a name adopted
`by FDA pursuant to § 701.3(c) of this
`chapter, its common or usual name, if
`it has one, or its chemical or technical
`name should be listed.
`(4) If an ingredient is a mixture, each
`ingredient of the mixture should be
`listed in accordance with paragraphs
`(d)(2) and (d)(3) of this section, unless
`such mixture is a formulation volun-
`tarily registered on Form FDA 2512, in
`which case such mixture should be
`identified as
`‘‘fragrance,’’
`‘‘flavor,’’
`‘‘fragrance and flavor’’ or ‘‘base formu-
`lation,’’ as appropriate, and by stating
`
`21 CFR Ch. I (4–1–12 Edition)
`
`its FDA-assigned cosmetic product in-
`gredient statement number.
`(5) When the manufacturer or sup-
`plier of a fragrance and/or flavor re-
`fuses to disclose ingredient data, the
`fragrance and/or flavor should be listed
`as such. The nonconfidential listing of
`the product name and/or trade name or
`name of the manufacturer or supplier
`of each proprietary fragrance and/or
`flavor mixture is optional.
`(e) A separate Form FDA–2512 should
`be filed for each different formulation
`of a cosmetic product. However, except
`for the hair coloring preparations list-
`ed in paragraph (c)(6) of this section for
`which a statement for each shade of
`such product is required, a single Form
`FDA–2512 may be filed for two or more
`shades of a cosmetic product where
`only the amounts of the color additive
`ingredient used are varied or in the
`case of flavors and fragrances where
`only the amounts of the flavors and
`fragrances used are varied.
`
`(Information collection requirements in this
`section were approved by the Office of Man-
`agement and Budget (OMB) and assigned
`OMB control number 0910–0030)
`
`[39 FR 10060, Mar. 15, 1974, as amended at 46
`FR 38073, July 24, 1981; 57 FR 3129, Jan. 28,
`1992]
`
`§ 720.5 [Reserved]
`
`§ 720.6 Amendments to statement.
`Changes in the information requested
`under §§ 720.4 (a)(3) and (a)(5) on the in-
`gredients or brand name of a cosmetic
`product should be submitted by filing
`an amended Form FDA 2512 within 60
`days after the product is entered into
`commercial
`distribution.
`Other
`changes do not
`justify
`immediate
`amendment, but should be shown by
`filing an amended Form FDA 2512 with-
`in a year after such changes. Notice of
`discontinuance of commercial distribu-
`tion of a cosmetic product formulation
`should be submitted by Form FDA 2514
`within 180 days after discontinuance of
`commercial
`distribution
`becomes
`known to the person filing.
`
`[57 FR 3130, Jan. 28, 1992, as amended at 67
`FR 9587, Mar. 4, 2002]
`
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`