Dear Ms. Gregory:

First let me extend my sincerest apologies for the delayed response. Although we make every effort to respond to each inquiry that we receive in a timely manner, on occasion there are number of contributing factors that impede our ability to achieve that goal. 

It is unclear from your email exactly what oil you are referring.  Again, the aluminum is the adjuvant.  Aluminum in the form of alum, aluminum hydroxide or phosphate is the only adjuvants used in U.S. licensed vaccines and there is no oil in those adjuvants. The adjuvant, as well as, certain inactive ingredients [That's right... only certain inactive ingredients not all of them. And peanut oil was considered totally safe for injection from the skin prick tests so it doesn't have to appear!! - bfg]  must appear on the package label.  General requirements for the package labeling can be found in 21 CFR 610.61.

Regarding cell culture medium, 21 CFR 610.15 states, "extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for injection."  It would be inaccurate to infer that earlier culture mediums used in production could contain various proteins. [How can it possibly be inaccurate? It isn't illegal. - bfg]  However, some of the package inserts for cell cultured vaccines do provide information on protein contents used in the manufacturing of the product.

We hope this information is helpful. 

Feel free to provide a contact number so that we can discuss your specific questions and/or concerns.  Otherwise, you may contact our office directly toll free at 800-835-4709.

Sincerely,

H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.