Released by FDA: 10/13/00.  Posted by FDA:  10/19/00

Kathleen K. Wille, Ph.D.
Manager, Regulatory Affairs 
Johnson & Johnson Consumer Companies, Inc. 
199 Grandview Road 
Skillman, NJ 08558-9418

Re:  NDA 19-963 
       Renova (tretinoin emollient cream) 0.05% 
       MACMIS# 9192

Dear Dr. Wille:

As part of our routine monitoring program. the Division of Drug Marketing. Advertising, and Communications (DDMAC) has become aware of a direct-to-consumer (DTC) journal advertisement for Renova (tretinoin emollient cream) 0.05%, disseminated by Johnson and Johnson Consumer Companies, Inc., (J&J) that is in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.  Specifically, we refer to a journal advertisement (04DD3480B) for Renova that appears in the July/August. 2000 issue of Martha Stewart Living.  We object to your dissemination of this advertisement for the following reasons:

Misleading Efficacy Claims

“Before I even have to think about a face lift, I’m thinking Renova.”

J&J presents this header with a picture of a woman’s face and with the prominent sub-headers, "On1y Renova is approved...to reduce fine wrinkles” and "Renova actually changes your skin.”   These headers and the picture are presented prominently while the actual indication and limiting information is presented in a non-prominent manner.  Thus, the overall presentation misleading implies that Renova is more effective than demonstrated.

For example, J&J does not prominently present that Renova must he used in conjunction with a comprehensive skin care & sun avoidance program.  In fact, the approved product labeling (P1) states that many patients achieve desired effects on tine wrinkling with the use of comprehensive skin care and sun avoidance programs and emollient creams NOT containing tretinoin.  Also, the information that Renova does not eliminate wrinkles, repair sun damaged skin, reverse photo-aging or restore a more youthful skin is not prominently presented.  Instead this information is presented in running text without any emphasis in comparison to the more prominent headers.

J&J states that Renova is "so effective” and "it’s where the search for a truly effective wrinkle cream stops.”  These claims are misleading because they overstate the efficacy. In the clinical trials, the majority of patients had minimal or no improvement.  We note that J&J presents the efficacy rates in tiny print under the “before” and “after” pictures. However, this efficacy information is minimized and difficult to read as compared to the more prominent benefit claims.

Further, J&J presents Renova’s effect on "crow’s feet" in a prominent header but does not include the indication information from the Pl that Renova has demonstrated no mitigating effect on significant signs of chronic sun exposure such as coarse or deep wrinkling.

Unsubstantiated Superiority Claim

“Because it’s the only prescription cream approved by the FDA, it’s a step beyond cosmetic wrinkle creams.”

This claim is misleading because it suggests that Renova is better than other products without substantial supporting evidence.

Action Requested

You should immediately cease distribution of the journal advertisement and all other promotional materials for Renova that contain the same or similar claims or presentations cited in this letter.  You should submit a written response to us, on or before October 27, 2000, describing your intent and plans to comply with the above, in your letter to us, you should include a list of all promotional materials that were discontinued, and the discontinuation dates.

You should direct your response to me by facsimile at (301) 594-6771. or at the Food and Drug Administration. Division of Drug Marketing. Advertising, and Communications, HFD-42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications arc considered official.  In all correspondence regarding this particular submission, please refer to MACMIS ID# 9192 in addition to the NDA number.

Sincerely,

Cheryl Y. Roberts 
Regulatory Review Officer 
Division of Drug Marketing,
  Advertising and Communications