"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Dr. Janet Woodcock, FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research. "In addition to today's regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies”

The US Food And Drug Adminstration expressed its concern that the claims could mislead women and health care professionals.

The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of "bio-identical" as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.

The compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown.

In response to the FDA’s action, the  International Academy of Compounding Pharmacists said the FDA action would deny many women access to products that may help them when approved therapies do not.

"Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate ... This is a decision that should be left to doctors," L.D. King, executive director of the pharmacists' group, said in a statement.