Inspections, Compliance, Enforcement, and Criminal Investigations
Tatra Herb Company 6/1/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
June 1, 2011
Elaine H. Zofchak, Owner
Tatra Herb Company
222 Grove Street
Morrisville, PA 19067
Dear Ms. Zofchak:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your tea and botanical herb manufacturing, repacking, and distribution facility located at 222 Grove Street, Morrisville, PA, from February 5 through February 7, 2011. During our inspection, the investigator collected documentary samples, labeling, and promotional literature associated with your products. In addition, FDA reviewed your website at the Internet address www.tatraherb.com in May 2011. Based on our review of your product labeling and website, we have determined that your products, as described further below, are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA’s regulations through links on FDA’s Internet web site at http://www.fda.gov.
Unapproved New Drugs
Your Pau d’Arco (Taheebo), St. Johnswort, Burdock, Goldenseal, Capsicum Powder (Cayenne), Licorice, and Alfalfa Herb products are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims in your product labeling and on 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.
Examples of some of the claims observed on your Internet website include:
Pau d’Arco (Taheebo) [loose herbs, 4, 8, & 16 oz]:
- “Uses: AIDS, HIV, Cancer, Diabetes, Herpes . . . Liver Disorders . . . Toxemia . . . Candidiasis, Eczema, Hodgkin’s Disease, Leukemia . . . Rheumatism, Tumors”
St. Johnswort Herb [4 oz]:
- “Uses: AIDS, HIV, Bronchitis, Cancer . . . Tumors, Depression . . .Viruses . . .”
Burdock [Cut and Powder, 4, 8, & 16 oz]:
- “Uses: Acne, Allergies, Hay Fever, Arthritis . . . Cancer, Chicken pox, Colds, Constipation, Eczema . . . Hemorrhoids . . . Liver Disorders, Lung Disorders, Measles . . . Psoriasis, Rheumatism . . . Skin Disorders, Tumors . . . ”
Goldenseal [Cut and Powder, 1, 2, 4, 8, & 16 oz]:
- “Bronchitis . . . Colds, Colitis . . . Eye Infection, Gonorrhea, Gum Disease . . . Hemorrhoids, Infection . . . Liver Disorders, Membrane Infections . . . ”
Capsicum Powder (Cayenne) [4, 8, & 16 oz]:
- “Arthritis . . . High and low blood pressure, Bronchitis . . . Colds . . . Diabetes . . . Gastric Disorders . . . Lung disorders . . . Rheumatism . . . Stroke . . . Tumors, Ulcers . . .”
Licorice Root [Cut, Sticks, and Powder, 4, 8, & 16 oz]:
- “Addison’s Disease . . . Colds . . . Diabetes . . . Ear Infections . . . Hyperglycemia, Hypoglycemia, Lung Disorders . . .”
Alfalfa Herb [4, 8, & 16 oz]:
- “Anemia, Arthritis, Diabetes . . . Ulcers”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” as defined by section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Pau d’Arco (Taheebo), St. Johnswort, Burdock, Goldenseal, Capsicum Powder (Cayenne Pepper), Licorice, and Alfalfa Herb products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. 331(a)].
Misbranded Dietary Supplements
In addition, even if your products were not unapproved new drugs, they would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. 343]. Specifically, based on our review of product labels collected during the inspection, your TU-10™ Tumor & Cyst Tea Herb Tea, Starwest Botanicals Black Cohosh Root Powder, Black Cohosh Root Powder, Blue Cohosh Powder, Black Cohosh Root Capsule 8 Grain (100 Capsules), Burdock Root Capsules 5 Grain (100 Capsules), Burdock Root Capsules 8 Grain (100 Capsules), Starwest Botanicals Cayenne Pepper Powder, Capsicum Annum (Cayenne Pepper) Capsules 8 Grain (100 Capsules), Powdered Capsicum, Powdered Goldenseal Root, Goldenseal Root Capsules 5 Grain (100 Capsules), Goldenseal Root Capsules 8 Grain (100 Capsules), San Francisco Herb and Natural Food Co. Licorice Root, Licorice Root Capsules 8 Grain (100 Capsules), Starwest Botanicals Pau D’Arco Bark C/S, Starwest Botanicals St. Johnswort Herb C/S, St. Johnswort Capsules 8 Grain (100 Capsules), Pectoral Capsules 8 Grain (100 Capsules), Pectoral Herb Tea No. 2, and Pau d’Arco (Taheebo) Bark products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that their labels fail to bear nutrition labeling (“Supplement Facts” panel) as required under 21 CFR 101.36, and they do not appear to be exempt from this requirement. Under 21 CFR 101.36(h), dietary supplements are subject to certain exemptions if they meet the following criteria set forth in 21 CFR 101.36(h)(1): (1) they are offered for sale by a person who makes direct sales to consumers who has annual gross sales or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, and (2) their labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim.
These products are further misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. 343(i)(1) and 343(s)(2)(B)] in that their labels fail to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product.
In addition, your Black Cohosh Root Capsule 8 Grain (100 Capsules), Burdock Root Capsules 5 Grain (100 Capsules), Burdock Root Capsules 8 Grain (100 Capsules), Capsicum Annum (Cayenne Pepper) Capsules 8 Grain (100 Capsules), Goldenseal Root Capsules 5 Grain (100 Capsules), Goldenseal Root Capsules 8 Grain (100 Capsules), Licorice Root Capsules 8 Grain (100 Capsules), St. Johnswort Capsules 8 Grain (100 Capsules), and Pectoral Capsules 8 Grain (100 Capsules) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C 343(i)(2)] in that the products are contained in capsules, but the capsule ingredients are not listed on the label as required by 21 CFR 101.4.
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims in your literature and on your website were too numerous to list in this letter. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The Act provides for the seizure of illegal products, injunctions against the manufacturers and/or distributors of violative products, and criminal sanctions against persons responsible for causing violations of the Act [21 U.S.C. 332 and 334].
In addition, FDA has determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. 350d] and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection, you were advised of this requirement. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen days, please state the reason for the delay and the time within which the corrections will be completed.
Your written response should be sent to Kristina Donohue, Compliance Officer, at the address noted above. If you have any questions with regard to this letter, Dr. Donohue can be reached at 215-717-3078 or Kristina.Donohue@fda.hhs.gov.
P.O. Box 60
Morrisville, PA 19067
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director