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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Highland Laboratories, Inc. 04-Oct-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483~4996


October 4, 2005

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 06-07

Candis L. Scott, Chief Executive Officer
Highland Laboratories, Inc.
P.O. Box 199
Mount Angel, OR 97362

WARNING LETTER

Dear Ms. Scott:

The Food and Drug Administration (FDA) conducted an inspection at your facility located at 110 South Garfield, Mount Angel, Oregon, on June 29, 2005. During the inspection the investigator collected product labeling and literature for your product "Progesterone Cream." We have reviewed the product labeling and literature and we find that this product is marketed for the treatment, cure, mitigation, or prevention of disease.

The product "Progesterone Cream" is subject to a final regulation codified in Title 21, Code of Federal Regulations (21 CFR), section 310.530, Topically applied hormone-containing drug products for over-the-counter (OTC) human use. This regulation states that "[a]ny OTC drug product that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use . . . is regarded as anew drug . . ." The product labeling for "Progesterone Cream" represents and promotes the product as containing progesterone, which constitutes an implied therapeutic or physiological effect on the body in addition to the following claims that appear on the accompanying, product literature.

  • Can natural progesterone help ease PMS? In most cases yes."

  • If your body requires more progesterone to balance estrogen, progesterone cream may help.""

  • Natural progesterone may help those experiencing hot flashes, mood swings, and night sweats by maintaining hormonal balance. After menopause, supplementation with a natural progesterone cream will aid in restoring hormonal balance."

  • Highland's patented transdermal delivery system ensures that the progesterone is transported through the skin."

"Progesterone Cream" is a "drug" as defined in section 201(g) [21 U. S.C. 321(g)] of the Federal Food, Drug, and Cosmetic Act (the Act) and a "new drug" as defined in 201(p) [21 U.S.C. 321(p)] of the Act, because there is no evidence that it is generally recognized as safe and effective for its intended use. Under section 505 of the Act [21 U.S.C. 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).

This letter is not intended to be an all-inclusive review of all labeling and products your firm markets. It is your responsibility to assure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

We request that you take prompt action to correct this violation. Failure to promptly correct this violation may result in enforcement action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and injunction.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violation, including an explanation of any steps taken to prevent recurrence of similar violations . If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.

Your reply should be sent to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 483-4940.

Sincerely,

/S/


Charles Breen
District Director