Advisory opinion letter to Mr. Secretary

April 12, 1973 Dear Mr. Secretary:

Please be advised that the Institute represents Mr. Anthony L. Young in his efforts to obtain disclosure of the request for the advisory opinion and the information upon which the Commission Advisory Opinion No. 266based its conclusion in the matter of (16 C. R. S 15.265).

:vr. Young requested disclosure of these records in a letter dated January 23, 1973. In a letter dated January 31 , 1973, you advised him that his request had been "placed in the proper chan­ nel for expeditious treatment." To this date, Mr. Young has re­ ceived no agency disposition on his request. Because Mr. Young has an immediate need for the information the Commission has failed to act in nearly four months, and the Freedom of Information Act mandates prompt disclosure of iden­ tifiab:e records, we respectfully request that the information be made availab:e by April 30 , 1973. In the alternative, we request that the Commission s written reasons for nondisclosure be sent to us by that date.

If neither the requested records nor the Commission s written reasons for nondisclosure is made available by that date, we will be compelled to conclude that the Commission s inaction consti­ tutes a denial of the request for disclosure. Based on the provi­ sions of 16 C. R. S 4. 10(d) (revised as of February 3 1973), we will also be compelled to conclude that the inaction constitutes

final agency action and wil take further action consistent with the Act' s requirement of prompt disclosure. Sincerely,

/s/ Richard B. Wolf, Esq.

/s/ Caliph Johnson, Esq.

February 13, 1973 Dear. Mr. Dietrich:

By Jetter of January 23, 1973, I sought to inspect, pursuant to the Freedom of Information Act, 5 V. C. 552, the request and the information upon which the Commission based its conclusion in the matter of Advisory Opinion No. 265, 33 F.R. 9816, July 9 1968.

On January 31, 1973, Mr. Tobin acknowledged receipt of my request and advised that it had been placed in the proper channel for expeditious treatment.

On February 9, 1973, :lfr. Neil Arthur of your Offce of Legal Services advised by telephone that the file in the matter could be inspected at the Commission s Public Documents Room at my con­ venience. On February 12, 1973, Mr. Arthur advised that he had been in error on February 9 , and that this file was protected by some kind of grandfather clause and further that the request for inspection must be cleared either by you or the full Commission. On February 13, 1973, Mr. Arthur advised me that the request the digest and the opinion in the matter would be available but that the facts and scientific information to which the Commission specifically referred might be exempt from disclosure. REASON FOR REQUEST While the Freedom of Information Act does not require that a person requesting information from a federal agency give reasons for such request, I would like to explain that I am concerned with the regulatory status of feminine deodorant sprays, most of which contain ingredients which cause the products to inhibit the growth of body odor causing bacteria. Advisory Opinion :\0. 265 con­ cludes that such products are cosmetics. Inasmuch as the growth of body odor causing bacteria is a function of the body of man and inasmuch as "articles intended to affect the structure or any function of the body of man" are drugs ADVISORY OPINIONS AND REQUESTS THEREFOR 1945

by definition, it would appear that the Commission has made an error.

The Commission s possible error has been compounded by the reliance which the Food and Drug Administration, through its General Counsel, places on Advisory Opinion No. 265. In a tele­ phone conversation with Mr. Hutt on December 22, 1972, I raised the question of whether feminine deodorant sprays might be drugs since they utilize antibacterial ingredients to obtain deodorant effect. While not specifically agreeing with it, Mr. Hutt cited Advi­ sory Opinion No. 265 as authority for the proposition that these products are not drugs.

I might add that the Advisory Opinion No. 265 has the potential of clouding other important regulatory action. The FDA is now reviewing the safety and effcacy of antimicrobial ingredients used in bar soaps. Some of these products make claims of antibacterial effect (Safeguard) and are classified as drugs while others claim only deodorant effect (Lifebuoy) and are classified as cosmetics. , however, contain the same antimicrobial ingredients and an are intended to inhibit the growth of odor causing bacteria. The pernicious impact of Advisory Opinion No. 265 is so great that FDA has considered asking the Commission to withdraw it. Because of an this, it is necessary that I examine the facts and scientific information utiJized by the Commission in reaching its decision. This is preliminary to asking that the opinion be reconsid­ ered.

SECRECY From my conversations with Mr. Arthur, it is my understand­ ing that prior to October 11 , 1969, the Commission granted blan­ ket confidentiality to requests for advisory opinions in order to encourage competitors to look before leaping. Although it is not apparent from the Code of Federal Regulations, the Commission advised its staff that this poJicy had changed on the above date. I would assume that only trade secrets are now protected. The Freedom of Information Act became Jaw on July 4, 1967. I would consider that any blanket grant of confidentiaJity by the Commission after that date to be u'tra vires and without effect. I do not desire to see Regal Chemical's trade secrets. Nor do I desire to see any of their commercial or financial information which is privileged or confidential. None of the above classes of information appear to have been necessary to the decision of the Commission.

I do not desire to see inter-agency or intra-agency memoranda. However, if these memoranda contain factual or scientific data which can be disentwined from the staff recommendation process and the factual data is not within some other exemption, so much of the memoranda as is of a factual character must be disclosed. By copy of this letter, I am advising Mr. Hut! of my request. I would also ask that you contact him with regard to this matter inasmuch as Advisory Opinion No. 265 appears to be covered by paragraph III (a) (1) and (2) of the FTC-FDA Memorandum of Understanding.

It is requested that the written reply I receive from you or from the Commission constitute final agency action.

Sincerely yours,