Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm355512.htm
Timestamp: 2019-04-23 22:12:15+00:00

Document:
On January 31 through February 11, 2013, Food and Drug Administration (FDA) investigators inspected your dietary supplement manufacturing facility located at Rt. 5, Box 1126, Ava, MO. During the inspection, our investigators identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause dietary supplements manufactured at your facility adulterated within the meaning of Section 402(g)(1) of the Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators’ observations were noted on form FDA-483, Inspectional Observations, which was issued to you on February 11, 2013.
Additionally, our investigators collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. We also reviewed labeling on your website at www.teetercreekherbs.com in March 2013. Based on our review of your product labeling, we have determined that your Lymphaid, Astragalus, Pau d Arco, Violet, Sheep Sorrel, Blood Build, Red Clover, Yellow Dock, and Immunaid 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 on your labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Further, your Mistletoe and Burdock Root dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101. In addition, if your Immunaid, Blood Build, Lymphaid, Astragalus, Pau d’Arco, Yellow Dock, Violet, Sheep Sorrel, and Red Clover products did not have disease claims, which make these products drugs, they would also be misbranded for the same reason.
We acknowledge receipt of your letter, dated February 21, 2013, and address it below.
“[P]rograms for cancer emphasize blood-purifying and detoxifying herbs….best results when the immune reserve builders are used. The immune system is the body’s own defense against cancer. Maitake has been shown to … have a number of important anti-cancer and anti-tumor compounds. Shitake and Turkey Tail as well. Astragalus has been show in studies to bring back the immune system after chemo- and radiation therapy.
“The following is a list of health issues and some of the herbs and formulas … used as … aids.
The products identified above are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. §321(p)(1)]. 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, 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. Thus, the labeling of Lymphaid, Astragalus, Pau d Arco, Yellow Dock, Violet, Sheep Sorrel, Blood Build, Red Clover, Yellow Dock and Immunaid fails to bear adequate directions for their intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. §352(f)(1)]. The introduction of these products into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
You failed to qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, you relied on a supplier’s COA for the component, (b)(4), used in all dietary supplement products you manufacture and distribute. However, you were unable to provide documentation for the qualification of your supplier for this component and you stated that you were unaware that you were required to establish the reliability of the supplier’s COA prior to using the component in the manufacture of your dietary supplement products.
Your letter dated 2/21/13 is inadequate because you failed to address the qualification of your supplier’s COAs for the component (b)(4), used in the manufacture of all of your dietary supplement products.
You failed to establish a specification for any 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 master manufacturing record, as required by 21 CFR 111.70(a). Specifically, your firm is conducting organoleptic and/or macroscopic examination on all components, labels and finished products; however, you did not provide any documentation to show that you have established specifications. Your master manufacturing records for your Lymphaid, Bld-Build and Immunaid products did not include specifications for each point, step, or state in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Consequently, since you failed to establish specifications, it is not possible for you to determine whether your examinations of components, labels, and finished products are appropriate to verify whether specifications are met, in accordance with 21 CFR 111.75.
Your letter dated 2/21/13 is inadequate because you failed to include any details regarding establishing specifications. We note that you stated that you will create documents over the next year to provide specifications; however, you did not indicate how you will ensure the quality of your dietary supplement products that are manufactured and distributed prior to the next year when you commit to establishing specifications.
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, you were not able to provide MMRs for any of your dietary supplement products that you manufacture, other than for Bld-Build, Lymphaid, and Immunaid.
You failed to include the strength, concentration, and weight of the dietary supplement to be manufactured, and the measure of each dietary ingredient for each batch size [21 CFR 111.210(a)]. Specifically, your MMR for your Lymphaid product indicated a yield of (b)(4) oz; however, a review of your batch production record with the date (b)(4) indicated a yield of (b)(4)oz. You indicated that you had increased the amounts of each dietary ingredient used to make a bigger batch, but you did not prepare a MMR for the larger batch size.
You failed to include an accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)]. Specifically, your MMR for your Bld-Build product indicates the addition of (b)(4)oz of the raw ingredient “Nettles”; however, your MMR does not indicate whether the ingredient is to be added in dried or liquid form. You indicated to our investigators that you vary the amount of Nettles in your finished product based on the availability of each form. You do not prepare a unique formulation for the use of dry herbs versus liquid extract, or a combination of the two, to assure that each batch of finished product is uniform. Likewise, your MMRs for your Immunaid and Lymphaid products call for specified amounts of ingredients, but do not specify the form, and you indicated that you vary the form and amounts routinely.
You failed to include the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label [21 CFR 111.210(d)]. Specifically, you routinely use the ingredient, Watercress, in your Bld-Build product, and Watercress is listed on your product label; however, your MMR does not indicate Watercress in the formulation of the product. Similarly, the ingredient, Licorice or Licorice Root, is listed in your Immunaid MMR and is used in your Immunaid product; however, you indicated that this ingredient was used as a substitute for Turkey Tail Mushroom, which is listed on your Immunaid product label.
You failed to include 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 master manufacturing record [21 CFR 111.210(h)(1)].
Your letter dated 2/21/13 is inadequate because you failed to address preparing and following a complete written master manufacturing record for each unique formulation of dietary supplement that you manufacture.
Your failed to prepare a batch production record (BPR) every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you were unable to provide a BPR for your “VioLet (b)(4)#2” product that is currently held for sale. Furthermore, the BPRs that you did provide for your Astragalus (lot size (b)(4)), Pau D Arco (lot size (b)(4)), Mistletoe (lot size (b)(4)), Yellow Dock (lot size (b)(4)), Violet (lot size (b)(4)), BLD-Build (lot size (b)(4)), Immunaid (lot size (b)(4)) and Lymphaid (lot size (b)(4)) products failed to include complete information relating to the production and control of each batch of dietary supplement that you manufacture, as required by 21 CFR 111.255(b). Specifically, your BPRs document the date of manufacturing, product name, and yield, but fail to include all other required information under 21 CFR 111.260. Furthermore, the information that is included on your BPRs is incomplete and inconsistent. You must prepare a BPR for each batch of dietary supplement that you manufacture with complete information, as required by 21 CFR 111.255(b) and 21 CFR 111.260.
In your letter dated 2/21/13, you stated that you have created a new template for batch records that are now in use. However, as you did not submit the revised batch record, nor did you submit any documentation to show that you are now using this revised template for batch records, we have found your response to be inadequate.
Your Mistletoe and Burdock Root dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101. If your Immunaid, Blood Build, Lymphaid, Astragalus, Pau d’Arco, Yellow Dock, Violet, Sheep Sorrel, and Red Clover products did not have disease claims, which make these products drugs, they would also be misbranded for the same reason.
The nutrition information for your single herb extract product labels lists the single dietary ingredient (herbs) contained in each product but fails to list the quantitative amount by weight per serving of the dietary ingredient in accordance with 101.36(b)(2)(ii).
The nutrition information for your Immunaid, Bld-Build, and Lymphaid herbal formula labels lists a proprietary blend of ingredients but fails to list the quantitative amount by weight per serving of the proprietary blend in accordance with 101.36(c)(3).
Your herbal formulas, Immunaid, BLD-BUILD, and Lymphaid, and your single herb extracts, Astragalus, Pau d’Arco, Mistletoe, Yellow Dock, Violet, Sheep Sorrel, Burdock Root, and Red Clover 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 the Supplement Facts panels are not in an appropriate format as defined in 21 CFR 101.36. For example, the title “Supplemental Facts” should be changed to “Supplement Facts” [21 CFR 101.36(e)(1)].
Your Immunaid, BLD-BUILD, and Lymphaid products contain intervening material in the labels within the meaning of 21 CFR 101.2(e). The “Other ingredients” must be listed outside of the Supplement Facts box either in accordance with 21 CFR 101.4(g).
Your herbal formulas, Immunaid, BLD-BUILD, and Lymphaid, and your single herb extracts, Astragalus, Pau d’Arco, Mistletoe, Yellow Dock, Violet, Sheep Sorrel, Burdock Root, and Red Clover products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that they are dietary supplements marketed in the United States, but the labels do not include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
Your Immunaid, Bld-Build, Lymphaid, Astragalus, Pau d’Arco, Mistletoe, Yellow Dock, Violet, Sheep Sorrel, Burdock Root, Red Clover products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the labels fail to declare the servings per container in accordance with 21 CFR 101.36(b)(1).
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

References: §342
 § 321
 § 343
 §321
 §355
 §352
 § 331
 § 343
 § 343
 § 343
 § 343