Released by FDA: 10/6/00.  Posted by FDA:  10/19/00

Mr. Stephen A. Drake 
Optima Worldwide, Ltd. 
216 S. Marina Street, Suite 309 
Prescott, Arizona 86303

                                                                                          Ref: 0l-HFD-312-01

Dear Mr. Drake:

This responds further to your recent requests for Certificate(s) of a Pharmaceutical Product for GEDA PLUS^TM and SURETE^TM, which are offered by your firm for “drug” use as defined by section 201(g) of the Federal Food, Drug. and Cosmetic Act (the Act).  The labeling for these two drug products is essentially the same, and their formulations are identical.  Upon evaluation of the labeling, we have determined that both of these products violate the “new drug” and misbranding provisions of the Act as described below.

These products are labeled for combined over-the-counter OTC) vaginal contraceptive and vaginal antiseptic uses with extended effectiveness when used alone, with vaginal diaphragms. or with condoms.  The labelling includes statements, such as:

"...CONTRACEPTIVE AND ANTISEPTIC..."
"...vaginal contraceptive and antiseptic gel is designed as a spermicide for use alone or with a condom and/or diaphragm..."
"...has the property of remaining in the vagina for longer periods than comparable products..."
"...may he applied up to 4 hrs. prior to intercourse..."
"...spermicidal and lubricating..."
"...for prevention of pregnancy..."
"...TO USE GEDA PLUS ALONE.... The GEDA PLUS applicator... provides the correct amount of GEDA PLUS vaginal contraceptive gel to be used (5 cc) . . . For maximum protection intercourse should occur no later than 4 hours after insertion of GEDA PLUS into vagina..."


"...TO USE GEDA PLUS WITH A DIAPHRAGM. . . Place one applicator full of GEDA PLUS into the cup of the diaphragm. . . Insert the diaphragm...Intercourse should take place within 6 hours of insertion ... Do not remove diaphragm before 6 hours after last intercourse..."


"...TO USE GEDA PLUS WITH CONDOM. . . Apply GEDA PLUS into vagina...Partner may apply GEDA Lotion or GEDA PLUS to penis prior to putting on condom. . . GEDA PLUS . . . should remain in vagina for 6 hours following intercourse..."

According to the labeling and the information you have provided, GEDA PLUS^TM and SURETE^TM both contain as their active drug ingredients benzalkonium chloride (0.1%) and octoxynol-9 (0.2%).

In addition to its labeled vaginal contraceptive and antiseptic uses, SURETE^TM  is also promoted for use in preventing sexually transmitted diseases, such as "...HIV/AIDS, Herpes, Hepatitis B, Cytomegalovirus, Chlamydia, Trichomonas, and various bacteria including gonorrhea and G. Vaginalis and the surrogate for syphilis ... and candida..." by “... forming a chemical and physical harrier as it coats the walls of the vagina and cervix..." to “inactivate()" or by “[b]locking the transrnission [of]” the microorganisms that cause them.  These representations cause SURETE^TM to be misbranded under section 502(f)(1) of the Act, since this product does not bear adequate directions for such uses as further described under Title 21 of the Code of Federal Regulations, Section 201.5(a) [21 CFR 201.5(a)].

We are not aware of any data to show that these drug products are generally recognized by experts as safe and effective for their labeled uses.  Thus, they are “new drugs,” as defined by section 201(p) of the Act.  Because none of the products has a new drug application approved by the Food and Drug Administration (FDA), as described under section 505(b) of the Act, their marketing in the United States violates section 505(a) of the Act.

Your letters requesting certificates for GEDA PLUS^TM  and SURETE^TMstate that they are “under a FDA monograph.”  These letters cite the proposed rules that published in the Federal Register (i.e. 48 FR 46694, October 13, 1983. and 56 FR 33644. July 22, l991) and 21 CFR Parts 333 and 369 as the “Marketing Authority” for these products.

The October 13, 1983 Federal Register notice you referenced (48 FR 46694) is the Advance Notice of Proposed Rulemaking (ANPR), which published under FDA's OTC Drug Review for OTC vaginal drug products.  It represents the recommendations from the Advisory Review Panel on OTC Contraceptives and Other Vaginal Drug Products for establishing conditions under which OTC vaginal drug products are generally recognized as safe and effective and not misbranded.  This notice does not cover OTC contraceptives, which were discussed in a previous report by that Panel that published in the Federal Register of December 12, 1980.  The specific pages of the 1983 ANPR, cited in your letters (i.e. 48 FR 46694 at 46717-46718), refer to the Panel’s recommendations for benzalkonium chloride, among other quaternary ammonium compounds, for vaginal antiseptic use for relief of minor vaginal irritation.  On page 46717 of the 1983 ANPR, the Panel concluded that the data are insufficient to prove that this ingredient is safe and effective for the relief of minor vaginal irritation. In addition, the Panel made no recommendations for combining any active ingredients for vaginal use or for combining vaginal contraceptive and vaginal antiseptic uses in a single product.

Products containing the single active ingredient octoxynol-9 offered solely for OTC vaginal contraceptive use or solely for OTC vaginal antiseptic use for the relief of minor irritations, and products containing the single active ingredient benzalkonium chloride offered solely for OTC vaginal antiseptic use, are covered by the OTC Drug Review, because such products were marketed in the United States before the Review began.

The July 22, 1991, Federal Register proposal (36 FR 33644), cited in your !etters, is FDA’s tentative final monograph, which also published under the OTC Drug Review, for OTC first-aid antiseptics.  This proposal covers antiseptic products for treating minor cuts, scrapes. and burns.  It does not presently cover OTC vaginal antiseptics.  In the November 19, 1997 Federal Register (62 FR 61710) FDA reopened the administrative record under the Review for OTC topical antimicrobials to further evaluate OTC vaginal antiseptics, but only those in “douche” form that had been previously considered in the October 13, 1983 ANPR.  That action followed the Agency’s proposal on February 3, 1994 (59 FR 5226) to withdraw the October 13, 1983 ANPR.

Regarding your reference to 21 CFR 333 in your letters, currently this part includes only final monographs for topical antibiotics, antifungals, and acne preparations.  None of these final monographs presently covers topical vaginal drug products.

The regulations under 21 CFR 369. to which you have referred in your letters, pertain to required and recommended warnings and cautions for OTC drug labeling.  However. these regulations have no bearing on the “new drug” status of GEDA PLUS^TM and SURETE^TM as currently formulated and labeled.

Thus, neither the proposed rules nor the final regulations that you have cited support the legal marketing of these products in the United States.  Further, we are not aware of such products, as formulated and labeled, having ever been commercially marketed in this country so as to qualify them for evaluation under FDA’s OTC Drug Review.

The violations described above are not meant to he all inclusive.  It is your responsibility to ensure that all drug products manufactured and distributed by your firm comply with the Act.  Federal agencies are advised of the issuance of all Warning Letters pertaining to drugs and devices so that they may take this information into account when considering the award of contracts.  We request that you take action immediately to correct these violations.  Failure to do so may result in regulatory action without further notice and may include seizure and/or injunction.

Because GEDA PLUS^TM and SURETE^TM are unapproved “new drugs” and misbranded, as described above, the following Certificate(s) of a Pharmaceutical Product issued previously by FDA are no longer valid as of the date of this letter:

No. 08-073-99. dated August 20, 1999.for China, India, Thailand, and Taiwan 
No. 08-117-99, dated August 31, 1999, for Hong Kong 
No. 01-012-00, dated January 19, 2000 for the Philippines, and 
No. 07-017-00, dated July 19, 2000 for Nigeria.

Please respond to this office in writing within fifteen (15) working days of receipt of this letter.  Your response should describe the specific actions you will take. or have taken, to correct the violations described above.  It should also include an explanation of each step being taken to prevent recurrence of similar violations.  If corrective action cannot be completed within fifteen (15) working days, stale the reason for the delay and the time within which corrections will he completed.  Your reply should be directed to Mr. Kevin M. Budich, Compliance Officer, as follows:

Food and Drug Administration 
OTC Compliance Team, HFD-312 
7520 Standish Place, Room 165 
Rockville. Mary land 20855

If you have any questions about the content of this letter, you may contact Mr Budich at 301-594-1065.

Sincerely,

 

David J. Horowitz. Esq. 
Acting Director 
Office of Compliance 
Center for Drug Evaluation and Research