Department of Health and Human Services' logo Department 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

September 21, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

IN REPLY REFER TO: SEA 09-28

Christa H. Sparks, Manager
Mountain Meadow Herbs, Inc.
P.O. Box 9227
Kalispell, Montana 59904

WARNING LETTER

Dear Ms. Sparks:

The Food and Drug Administration (FDA) conducted an inspection at your facility, located at 5B Conestoga Court, Kalispell, Montana, on May 13-15, 2009. During that inspection, the investigator collected labeling associated with many of your products, including, Herbs for ADD (now marketed as Natural Attention-Aid), Anti-Inflammatory, Herbal Respiratory, T&C Formula, Flu Season (now marketed as Winter-Immune Booster), Infa-Flu, Blood Pressure Formula (now marketed as Herbal CardioCare), and ClarkRx (now marketed as ClarkFx). In addition, we reviewed labeling on your website http://www.mountainmeadowherbs.com on June 17 and 23, 2009, and August 26, 2009. A review of the labeling found the products are being offered are promoted for conditions that cause them to be drugs under section 201 (g)(1)(8) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(B)]. The claims on your labeling, including your website, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.

We received your response dated May 28, 2009, in which you included revised promotional materials and website descriptions for five products. We also received your letter of August 25, 2009, stating that you have updated your website and are updating your product labels, catalog and other promotional materials. Our review of your product labeling included your revised website and any revised materials you sent us.

Examples of the claims observed on your website, product labels, and other promotional materials include the following:

New Drugs

The above products are drugs, as defined by the Act, 21 U.S.C. § 321(g)(1)(B), because they are intended to cure, mitigate, treat, or prevent disease. Moreover, these products are "new drugs," as defined by 201 (p) of the Act [21 U.S.C. § 321 (p)], because there is no evidence that they are generally recognized as safe and effective for their labeled uses." Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatorv/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

Misbranded Drugs

Further, these products are misbranded under section 502(f)(1) of the Act in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].

Misbranded Dietary Supplements

Even if your products did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as dietary supplements. Your products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. 321 (q)(5)(F)] because they are labeled as dietary supplements, but they fail to bear nutrition labeling ("Supplement Facts" panel) as required under 21 CFR 101.36.

This letter is not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Please address your reply to the U.S. Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Errand, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Elrand at (425) 483-4913.

Sincerely,

/S/

Charles M. Breen
District Director

This page was posted on January 31, 2010.

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