Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021-4425
January 22, 2016
In reply refer to Warning Letter SEA 16-08
Leslie River Kennedy, President
Terra Firma Botanicals, Inc.
1010 Tyinn Street, Suite 5, 6, and 23
Eugene, Oregon 97402
Dear Ms. Kennedy:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing operation located at 1010 Tyinn Street, Suite 5, 6, and 23, Eugene, Oregon, on March 10, 11, 13, 17, and 19, 2015. Based on our inspection and subsequent review of your firm’s website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
Unapproved New Drugs
The FDA reviewed your website at http://www.terrafirmabotanicals.com in January 2016 and has determined that you take orders there for the products “Horse Chestnut Varicose Away Spray”, “YeastEaze Vaginal Suppositories”, “Hawthorne Combo”, “Skin Combo”, “Milk Thistle”, “Turmeric”, “Turmeric/Ginger Combination”, “Depress-Shun”, “Bliss”, “Candida and Fungus Away – Herbal Candida Relief”, and “Herp-Eaze Formula”. The claims on your website establish that these products are drugs as defined in section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include, but are not limited to:
- Horse Chestnut Varicose Away Spray: “***prevent thrombosis…anti inflammatory properties [sic]***”.
- YeastEaze Vaginal Suppositories: “***combating minor vaginal irritation and non-specific vaginitis***”.
- Hawthorne Combo: “***help regulate and balance the blood pressure***”.
- Skin Combo: “***for treating…eczema, psoriasis, dandruff, and rashes***”.
- Milk Thistle: “***rebuilds & regenerates damaged liver cells***”.
- Turmeric: “***remedy for arthritis***”.
- Turmeric/Ginger Combination: “***wonderful anti-inflammatory tincture***”.
- Depress-Shun: “***Herbal Panic Attack Relief***”.
- Bliss: “***Anxiety Relief***”.
- Candida and Fungus Away – Herbal Candida Relief: the name of your product establishes the intended use of your product as a drug.
- Herp-Eaze Formula: “***For those with chronic cold sores and/or herpes, our Herp-Eaze Formula will keep the virus at bay***”. In addition to the website claims, the name of your product establishes the intended use of your product as a drug.
These products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 301(d) and 505(a) of the Act [21 U.S.C. §§ 321(d), 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.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Horse Chestnut Varicose Away Spray, Hawthorne Combo, Skin Combo, Depress-Shun, Bliss, and Herp-Eaze Formula products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Horse Chestnut Varicose Away Spray, Hawthorne Combo, Skin Combo, Depress-Shun, Bliss, and Herp-Eaze Formula fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
We note that you market YeastEaze Vaginal Suppositories and Horse Chestnut Varicose Away Spray as dietary supplements. Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321 (ff)(2)(A)(i)], dietary supplements must be intended for ingestion. The product labeling indicates YeastEaze Vaginal Suppositories are intended for insertion into the body, and Horse Chestnut Varicose Away Spray is intended to be sprayed onto the body. Therefore, even if they were not unapproved new drugs, these products would not be dietary supplements as defined in section 201(ff) of the Act [21 U.S.C. § 321(ff)].
Adulterated Dietary Supplements
Even if your Milk Thistle product was not an unapproved drug, it would be an adulterated dietary supplement based on the violations listed below. In addition, your Black Cohosh, Passion Flower, Bilberry, and all other dietary supplement products manufactured in your facility are also adulterated dietary supplements. During the inspection, our investigator evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations and identified significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Part 111. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
Specifically, during our inspection, our investigators observed the following significant violations, which were noted on the Form FDA 483, Inspectional Observations, issued to you on March 19, 2015. We received your responses dated April 2, 2015, and July 12, 2015, and have addressed relevant information on those responses below.
1. You failed to prepare a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your firm has not prepared a written MMR for your Passion Flower, Milk Thistle, Black Cohosh, and Bilberry Fruit tinctures that you manufacture, and for each batch size.
We acknowledge in your response, dated April 2, 2015, in which you provided a MMR for Passion Flower extract. However, we cannot fully evaluate the MMR as it lacks required information, such as specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR (21 CFR 111.210(h)(1)); corrective action plans for use when a specification is not met (21 CFR 111.210(h)(5)); and specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR (21 CFR 111.210(h)(3)). We note that you provided a date for full compliance on this issue by June 21, 2015. To date, we have not received any further correspondence from you which addresses this issue.
2. You failed to establish the following specifications, as required by 21 CFR 111.70:
a. Identity specifications for the components you use in the manufacture of your dietary supplements, as required by 21 CFR 111.70(b)(1).
Specifically, you did not establish identity specifications for the passion vine used in your Passion Flower tincture, the milk thistle seed used in your Milk Thistle tincture, and the bilberry fruit used in your Bilberry Fruit tincture.
We acknowledge that you provided in your April 2, 2015, response an Ingredient Specification Sheet (ISS) for (b)(4) – Ethyl Alcohol (b)(4)%; however, we note that this would not comprise an appropriate component specification under 21 CFR 111.70(b)(1) because it does not contain information that specifies the identity of ethyl alcohol. In your April 2, 2015, correspondence you provided a date for full compliance on this issue of September 21, 2015. To date, we have not received any further correspondence from you that addresses this issue.
Once you have established the identity specification for each component, you must verify that the specifications are met in accordance with 21 CFR 111.75(a)(1)(i) and 21 CFR 111.75(a)(2), and you must make and keep records in accordance with 21 CFR 111.95(b).
b. Product specifications for the identity, purity, strength, and composition of the finished batches of your dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batches of those dietary supplements, as required by 21 CFR 111.70(e). Specifically, you did not establish specifications for your Milk Thistle, Black Cohosh, and Bilberry Fruit products.
We acknowledge that you provided in your April 2, 2015, response a Product Specification Sheet for Eleuthero Tincture (Liquid Extract). However, this product specification does not meet the requirements of 111.70(e) because it does not contain information to specify the identity, purity, strength, and composition of the dietary supplement product. We note that you provided a date for full compliance on this issue of October 21, 2015. To date we have not received any further correspondence from you that addresses this issue.
Once you have established product specifications for the identity, purity, strength, composition, and limits on contaminants for the finished product, you must verify that the specifications are met in accordance with 21 CFR 111.75(c) and you must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). In addition, you must make and keep records in accordance with 21 CFR 111.95(b).
3. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you do not have written quality control procedures for reviewing and approving packaging and labels (21 CFR 111.120); reviewing and approving all master manufacturing records (21 CFR 111.123(a)(1)), batch production-related records (21 CFR 111.123(a)(1)), and records for packaging and labeling (21 CFR 111.127(c)); conducting any material review and making any required disposition decisions for returned dietary supplements (21 CFR 111.130(a)); and reviewing and approving decisions about whether to investigate a product complaint (21 CFR 111.135).
In your April 2, 2015, written response, you provided a Quality Control Department (QCD) document outlining the job descriptions for individuals within the QCD. This response, however, is not adequate in that it does not fully describe the duties of the QCD personnel, nor does it address the procedures for the responsibilities of the quality control operations. We note that you provided a date for full compliance on this issue of December 21, 2015. To date we have not received any further correspondence from you that addresses this issue.
4. Your batch production records failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). Specifically, your batch production records for your Black Cohosh lot #1621, Passion Flower lot #1487, Milk Thistle lot #1608, and Bilberry Fruit lot #1627 tinctures lacked the following required information:
a. A statement specifying the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f).
b. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, when label reconciliation is required, and reconciliation of any discrepancies between issuance and use of labels, as required by 21 CFR 111.260(k)(1).
c. Documentation at the time of performance that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, as required by 21 CFR 111.260(l)(4).
We acknowledge in your June 12, 2015, response that you provided a sample “Tincture Batch Record” template. However, we are unable to assess the adequacy of your response because it does not contain information demonstrating that it has been implemented as it contains no batch information. We note that, if implemented, the proposed batch record may satisfy the requirement in (a) above were it to contain a statement of the actual yield and percentage of theoretical yield at appropriate phases of processing.
We note that in your initial April 2, 2015, response that you provided a date for full compliance on this issue of December 21, 2015. To date we have not received any further correspondence from you that addresses this issue.
Your response letter, dated April 2, 2015, indicates that corrective action for the violations listed on the Form FDA 483, Inspectional Observations, will be staggered, with final completion by February 21, 2016. That date is approximately 11 months from the day that corrections were promised.
This letter is not intended to be an all-inclusive list of the 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 ensure that your firm complies with the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations and implement lasting corrective action of these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations, or other similar violations, from occurring again. You should include documentation of corrective actions you have taken to date. If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
Your reply should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Patricia A. Pinkerton, Compliance Officer. Refer to the identification number WL SEA 16-08 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Patricia Pinkerton by telephone at 425-302-0428.
Miriam R. Burbach
cc: Oregon State Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301