Code of Federal Regulations

  Title 21, Volume 7, Parts 600 to 799

  Revised as of April 1, 1996

 From the U.S. Government Printing Office via GPO Access

  CITE: 21CFR730

 

  Page 198-200

 

         TITLE 21--FOOD AND DRUGS

 

 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

 

 PART 730--VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES--Table of Contents

 

 Sec.

 730.1  Who should file.

 730.2  Time for filing.

 730.3  How and where to file.

 730.4  Information requested.

 730.5  Additions or amendments to reports.

 730.6  Notification to person submitting reports.

 730.7  Confidentiality of reports.

 730.8  Misbranding by reference to filing; filing does not constitute an

           admission.

 

     Authority: Secs. 201, 301, 601, 602, 701, 704 of the Federal Food,

 Drug, and Cosmetic Act (21 U.S.C. 321, 331, 361, 362, 371, 374).

 

     Source: 39 FR 10062, Mar. 15, 1974, unless otherwise noted.

 

 Sec. 730.1   Who should file.

 

     Every person who is a manufacturer, packer, or distributor of a

 cosmetic product is requested to file a Form FD-2704 (Cosmetic Product

 Experience Report), with respect to all reportable experiences which

 have been reported to him concerning any of his cosmetic products in

 commercial distribution, regardless of whether he is a participant in

 the voluntary program to register cosmetic product establishments

 pursuant to part 710 of this chapter, and regardless of whether he is a

 participant in the voluntary program to file cosmetic product ingredient

 and raw material composition statements pursuant to part 720 of this

 chapter. In addition, every person who is a manufacturer, packer, or

 distributor of a cosmetic product, whether or not he has received any

 information concerning a reportable experience in regard to any of his

 cosmetic products in his system of commercial distribution, is requested

 to file a Form FD-2706 (Summary Report of Cosmetic Product Experience by

 Product Categories). This request extends to any foreign manufacturer,

 packer, or distributor of a cosmetic product imported into any State. No

 filing fee is required.

 

  39 FR 10062, Mar. 15, 1974, as amended at 46 FR 38073, July 24, 1981

 

 Sec. 730.2  Time for filing.

 

     (a) Reportable experiences should be reported on an annual basis,

 for the period January through December, not later than 60 days after

 the close of the reporting period.

     (b) A summary report of cosmetic product experience by product

 categories should be filed on an annual basis, for the period January

 through December, not later than 60 days after the close of the

 reporting period.

 

  51 FR 25687, July 16, 1986

 

 Sec. 730.3  How and where to file.

 

     Form FDA 2704 (Cosmetic Product Experience Report) and Form FDA 2706

 (Summary Report of Cosmetic Product Experience by Product Categories)

 are obtainable from, and the completed forms should be mailed or

 delivered to, Cosmetic Product Experience Report, Center for Food Safety

 and Applied Nutrition (HFS-100), Food and Drug Administration, 200 C St.

 SW., Washington, DC 20204.

 

  51 FR 25687, July 16, 1986, as amended at 61 FR 14481, Apr. 2, 1996

 

 Sec. 730.4   Information requested.

 

     (a) Form FD-2704 (Cosmetic Product Experience Report) requests the

 following information:

     (1) The name of the person (manufacturer, packer, or distributor)

 designated on the label of the cosmetic product.

     (2) Time period covered by the report.

     (3) The complete name of the cosmetic product exactly as it appears

 on the label of the product.

     (4) The cosmetic product category, as set forth in Sec. 720.4(c) of

 this chapter and on the form, which best describes the product's

 intended use.

     (5) Total number of reportable experiences during this reporting

 period and number of these experiences requiring professional medical

 attention.

     (6) Total number of product units of the cosmetic product estimated

 to have been distributed to consumers during this reporting period.

 

   Page 199

 

     (7)-(8)  Reserved

     (9) The cosmetic product ingredient statement number (CPIS No.)

 assigned to the product under Sec. 720.7 of this chapter, if known. If a

 number is pending, but has not been assigned, the firm should so

 indicate. Where the firm submitting the report knows that a cosmetic

 product ingredient statement pursuant to part 720 of this chapter has

 not been filed, it should so indicate.

     (10) Any additional evaluation of the experiences or other pertinent

 data or information as the person filing wishes to provide to assist the

 Food and Drug Administration in evaluating the report.

     (b)  Reserved

     (c) Form FD-2706 (Summary Report of Cosmetic Product Experience by

 Product Categories) requests the following information:

     (1) The name and address (include country, if other than the United

 States), including post office ZIP code of the person (manufacturer,

 packer, or distributor) designated on the label of the cosmetic

 products.

     (2) Time period covered by the report.

     (3) Total number of product units within each product category, as

 set forth in Sec. 720.4(c) of this chapter and on the form, estimated to

 have been distributed to consumers during this reporting period.

     (4) Total number of reportable experiences within each product

 category during this reporting period, if any.

     (d) The person filing a Form FD-2704 (Cosmetic Product Experience

 Report)or Form FD-2706 (Summary Report of Product Experience by Product

 Categories) should:

     (1) Provide the information requested in paragraphs (a) and (c) of

 this section, as appropriate.

     (2) Provide the screening procedure in conformance with

 Sec. 700.3(p) when a screening procedure is used in connection with the

 reports requested by this part and is not already on file with the Food

 and Drug Administration.

     (3) Provide the name, title, and signature of the individual

 authorized to submit the report(s), and the name and address of the firm

 which he represents if it differs from that provided in paragraph (a) or

 (c) of this section.

     (e) The information requested under paragraph (a) of this section

 should be filed separately for each cosmetic product, except that a

 single report may be filed for two or more shades, flavors, or

 fragrances of a cosmetic product where only the proportions of these

 ingredients are varied, and such product is covered by a single cosmetic

 product ingredient statement under Sec. 720.4(e) of this chapter.

     (f) On the basis of a review of individual reports or patterns of

 experience disclosed as a result of a number of reports, the

 Commissioner of Food and Drugs may request as much additional

 information from persons submitting reports as the Commissioner deems

 appropriate. For this reason, every person participating in this program

 should retain for three years all correspondence and records pertaining

 to alleged cosmetic product injuries.

 

  39 FR 10062, Mar. 15, 1974, as amended at 46 FR 38074, July 24, 1981;

 51 FR 25687, July 16, 1986

 

 Sec. 730.5   Additions or amendments to reports.

 

     Additions or amendments to any experience report should be submitted

 by filing the appropriate amended form as soon as the need for such

 additions or amendments becomes apparent to the person submitting the

 original report.

 

 Sec. 730.6   Notification to person submitting reports.

 

     Anyone desiring a receipt for information submitted should send it

 by registered mail requesting a return receipt.

 

 Sec. 730.7   Confidentiality of reports.

 

     The availability for public disclosure of all data and information

 contained in, attached to, or included with Forms FD-2704, 2706, and

 amendments thereto, shall be handled in accordance with the provisions

 established in part 20 of this chapter. All such data and information

 are submitted voluntarily to the Food and Drug Administration and are

 thus subject to the specific provisions concerning data and information

 submitted voluntarily to the Food and Drug Administration in Sec. 20.111

 of this chapter, as well as to the exemptions in subpart D of part 20 of

 this chapter and

 

   Page 200

 

 the limitations on exemptions in subpart E of part 20 of this chapter.

 

  39 FR 44657, Dec. 24, 1974, as amended at 42 FR 15676, Mar. 22, 1977;

 46 FR 38074, July 24, 1981

 

 Sec. 730.8   Misbranding by reference to filing; filing does not

           constitute an admission.

 

     (a) The filing of an experience report does not in any way denote

 approval of the firm or the cosmetic product by the Food and Drug

 Administration. Any representation in labeling or advertising that

 creates an impression of official approval because of such filing will

 be considered misleading.

     (b) The filing of an experience report does not in any way

 constitute an admission by the person filing the report that the alleged

 experience was the result of an ingredient or ingredients in the

 cosmetic product, or of any other fact.