Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Kansas City District|
11630 West 80 Street
Lenexa, Kansas 662143340
Telephone: (913) 752-2100
May 19, 2008
RETURN RECEIPT REQUESTED
Mr. Robert M. Liebert, President, Co-Owner
Ms. Jan M. Liebert, Co-Owner
Teeter Creek Herbs Company
Route 5, Box 1126
Ava, MO 65608
Ref. KAN 2008-08
Dear Mr. and Ms. Liebert:
This letter follows the March 11, 2008 inspection of your firm, located on Route 5, Box 1126, Ava, Missouri, by investigators of the Food and Drug Administration (FDA). During the inspection, our investigators collected labels of several of your Teeter Creek Herbal products. Our review of your product labels, in addition to the promotional claims viewed on your website at the Internet address http://www.teetercreekherbs.com, found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and FDA's regulations through links on FDA's Internet page at www.fda.gov.
The violations are as follows:
The products "Hrt-Tone," "Immunaid," "St. John's Wort Oil," "St. John's Wort," "Sugarease," "Lvr-Tone," and "Echinacea/Goldenseal" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims on your website include the following:
"Prevent high blood pressure, arteriosclerosis. Heart disease.... Angina; some types of palpitation. Hawthorn has some potentizing effects on digitalis-type heart medication..."
"Effects of chemo- and radiation therapy. Auto-immune conditions. Chronic allergies. And aid in cancer, HIV, chronic immune deficiency."
St. John's Wort Oil
"Aids in nerve pain, sciatica, neuralgia, ...sunburn, swelling, inflamation [sic], recent injuries."
See also last sentence of claim for St. John's Wort, below.
St. John's Wort (Single Herb Extract)
"St. John's Wort has long been honored for it's [sic] wide range of uses... Depression... Insomnia. Headache. Nerve pain. Neuralgia. Sciatica. Injury to nerves. Spinal pain. Skin conditions with acute pain (shingles, etc.) Has anti-viral anti-bacterial properties. Good, mild anti-infection herb for kids... [I]ncontinence... Menopausal depression... Passive hemorrhage. Externally the liquid extract or the Oil of St. John's Wort can be used for recent,painful injuries with nerve pain, swelling, sprains, ... [or] in ear for pain and infection."
"A tonic for... elevated blood sugar."
"Liver pain. Gall bladder congestion and irritation. Medium length use for impaired liver."
Because these products are not generally recognized as safe and effective when used under the conditions prescribed, recommended, or suggested in their labeling, they are new drugs as defined in § 201(p) of the Act. Under §§ 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. Your sale of herbal products labeled with therapeutic claims without an approved application violates these provisions of the Act.
Because these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use them safely for their intended uses. The labeling of Hrt-Tone," "Immunaid", "St. John's Wort Oil", "St. John's Wort", "Sugarease", and "Lvr-Tone" fails to bear adequate directions for their intended uses, causing them to be misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
Even if these products were not promoted with disease claims that make them drugs, "Hrt-Tone", "St. John's Wort", and "Immunaid" would be misbranded dietary supplements. Our review of the labels for these products, which were collected during the inspection, reveals the following violations:
- Your products are misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B)of the Act in that the labels fail to identify the products using the term "dietary supplement" as part of the statement of identity on the principal display panel, as required by 21 CFR 101.3(a) and (g).
- Your products are misbranded within the meaning of section 403(q)(5)(F) of the Act in that the labels fail to bear nutrition labeling ("Supplement Facts" panel), as required by 21 CFR 101.36.
The violations cited in this letter are not intended to be an all-inclusive list. 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 described above and prevent their future recurrence. Failure to promptly correct these violations may result in legal action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please advise this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you will take, or have taken, to correct the violations identified in this letter and any other violations of the Act, and to assure that similar violations do not occur. Your response should include an explanation of each step being taken to correct the current violations and prevent similar violations. Include copies of any available documentation demonstrating that corrections have been made. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented. Please direct your response to Nadine Nanko Johnson, Compliance Officer, Food and Drug Administration, at the above letterhead address.
John W. Thorsky
This page was posted on July 19, 2010.