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U.S. Department of Health and Human Services

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Enforcement Actions

Mountain Meadow Herbs, Inc. 9/21/09

   

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

 


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:


Natural Attention-Aid (formerly Herbs for ADD)


From the product label:


• "ADD Relief"


From the 2009 catalog entitled herbal care guide:

• "A unique blend of herbs designed to help improve and alleviate the symptoms of Attention Deficit Disorder."


From the pamphlet:


• "[A] welcome antidote for the challenges of Attention Deficit Disorder (ADD), and Attention Deficit Hyperactivity Disorder (ADHD)."


Winter-Immune Booster (formerly Flu Season)


From your website:


• Under product information: "Previously known as Flu Season" 

 

From the 2009 catalog entitled herbal care guide:


• "Oregon Grape Root and Barberry are widely used to combat infections of all kinds while the Olive Leaf and Nettle help fight and suppress numerous kinds of bacteria and many strains of viruses. For best results, take as soon as flu symptoms appear."


From the pamphlet:


• "FLU SEASON An excellent remedy to keep on hand, especially during those months when the flu bug is making its rounds! We, along with many of our customers, have found it to be very effective, especially when taken as soon as flu or cold symptoms appear. The herbs in this formula have shown to be effective in fighting and suppressing the viruses and bacteria that cause the common cold, stomach flu, tonsillitis and respiratory infections."


Herbal Respiratory


From the 2009 catalog entitled herbal care guide:


• "[U]seful in alleviating recurrent bronchial/respiratory infections."


From the pamphlet:


• "Stop recurrent colds" "age 12 yrs and older: Take % teaspoon 1-3 times daily. During the acute stage of illness, dosage can be repeated every 4 hours."


Infant Immune-Booster (formerly Infa-Flu)


From the product label:


• "Infant Flu Symptom Relief"
• Further, the name of your product implies flu treatment.


From the pamphlet:


• "Infa-Flu is the answer to your search for a safe, natural way to effectively fight infection when your little one is suffering from the flu or the common cold. Infa-Flu can also be very helpful in alleviating ear infections ... "


Para-Rid


From the pamphlet and website:


• "This formula was designed to destroy and expel worms."


Parasite Cleanse


From your website:

• "Dr. Clark found through her research that you could rid yourself of over 100 types of parasites with just three herbs! ...What three herbs? Black Walnut Hulls, Wormwood and Cloves. All three herbs should be used together. Black Walnut Hull and Wormwood help kill adults and developmental stages of at lease 100 parasites, while cloves kill the eggs.... "

Fruitful Vine


From the 2009 catalog and website:


• "[T]raditionally used to alleviate barrenness."


Femme Defense


From the 2009 catalog and website:

• "Femme Defense combines the highest quality herbal extracts to deliver the most effective means of empowering the body in relieving and preventing conditions common and sometimes fatal to woman."


Anti-Inflammatory


From the product label:


• "Pain and Inflammation Relief"


From your website:


• "Used to alleviate occasional pain and swelling naturally. The herbs in this formula have traditionally been used to help alleviate mild pain and swelling especially in the back, head, and joint."


From the 2009 catalog entitled herbal care guide:


• "This formula is a natural pain reliever that can be used in place of over-the-counter pain relievers."


From the pamphlet:


• "Alleviates pain and inflammation associated with several types of arthritis; also, the pain associated with back pain"


• "Helps to alleviate pain and inflammations specifically pain caused by headaches. Also, helps to reduce fever."


T & C Formula


From the 2009 catalog entitled herbal care guide:


• An excellent product for those who suffer from endometriosis, painful menstruation, Pelvic Inflammatory Disease, Polycystic Ovary Syndrome (PCOS)... [i]t works to reduce swelling and inflammation ... "


From the pamphlet:


• "The T&C Formula is the answer to your search for natural relief from endometriosis ... "


• "[M]any women report no pain or a significant decrease in pain after taking the T&C Formula for only two weeks!"


Herbal CardioCare (formerly Blood Pressure Formula)


From your website:


• "Suggested Use: Take ¼ teaspoon and check your blood pressure. After 15-25 minutes check your blood pressure again. If your blood pressure reading has not normalized take another dose. Continue taking ¼ tsp. every 15-25 minutes until your blood pressure reading normalizes."


• "Ingredients Details: Organic Bilberry Leaf & Berry - helps support... blood pressure and cholesterol levels."


From the 2009 catalog entitled herbal care guide:


• "This formula has been used with remarkable success in alleviating high blood pressure. It is especially specific to hypertension caused by kidney problems."


From the pamphlet:

 

• "The Blood Pressure Formula is designed to decrease high blood pressure, or hypertension, by enhancing blood circulation and health to the heart."


• "[H]elp prevent hypertension ... also helps to prevent Atherosclerosis (hardening of arteries). The herbs antioxidant qualities inhibit oxidation of LDL cholesterol, reducing the risk of heart attacks."


ClarkFx (formerly ClarkRx)


From your website:


• "Primarily it is used as a powerful parasite eliminating formula, but can also be used ... externally on sores, and injuries.".


• ''The original formula has now been enhanced by the addition of Green Rooibos Tea, which ... helps the wormwood to be more effective in expelling parasites. This is the easy way to do Dr. Hulda Clark's parasite cleanse found in her book 'The Cure for All Diseases.' Some common parasites are: flukes, sheep liver flukes, pinworms, threadworms, hookworms, roundworms, and tapeworms."


From the 2009 catalog entitled herbal care guide:

• "The formula is best known as a natural remedy for expelling intestinal parasites. What is best known is that it can also be an effective natural antibiotic. It is not only able to suppress infections caused by parasitic bacteria, but also those caused by viruses... "

From the pamphlet:


• "Parasites: ClarkRx may be effective for flukes, pinworms, threadworms, hookworms, round worms, tapeworms, amoebas, giardia"


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