AHPA Legal Alert
Editor's Note: FDA warns South Texas Botanicals for claims on product labels and mail order catalogs that FDA alleges establish the products as drugs. The warning letter alleges several labeling violations and cGMP violations that cause FDA to consider the products to be adulterated dietary supplements. FDA acknowledges the company's response, but notes it is unable to evaluate the company's corrective actions because it failed to provide adequate documentation.

Food and Drug Administration
March 29, 2018


On September 29 and October 2, 4, and 6, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 4156 Gaitan Lane, Beeville, Texas. Based on the inspection, a review of the product labels collected and a review of your mail order catalog, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA's website at www.fda.gov.
 
We acknowledge receipt of your October 14, 2017 response to the Form FDA 483 issued to you at the close of the inspection. We address relevant portions of your response below.
 
Unapproved New Drugs
 
FDA reviewed your firm's mail order catalog in November 2017, following our inspection of your facility. We have determined that this mail order catalog is product labeling that promotes several of your products for conditions that cause them to be drugs under Section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The claims within your catalog  establish that these products are drugs 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 claims within your South Texas Botanicals Catalog # 18 that provide evidence that your products Oral Health, LDMS Formula, CE, Papaya LF Tea, Candida Control, Composition Formula, Diabetic Formula, Health Hormone, Incontinence, Joint Support, Mag 4, HW Formula, Pain Ease, R-Lung, and VV Formula are intended for use as drugs include:
 
Oral Health:
  • "[U]sed traditionally for their antiseptic (germ killing properties), pain reliving and healing properties. . ."
  • "Try this formula for mouth sores, gum disease, toothaches, cavities, sore throat. . ."
     
LDMS Formula:
  • "[D]eveloped for those who battle chronic depression. . ." 
CE:
  • "Colon  Elixir,  is  a  blend  thought  to  be  helpful  with  chronic  diarrhea, food Poisoning. . ."
Papaya LF Tea:
  • "[I]ncrease platelet count, preventing the need for a blood transfusion. . ."
  • "It appears to have been effective to increase platelet count, preventing the need for a blood transfusion . . .to use along when dealing with lyme (sic) disease. . . "
Candida Control:
  • Candida is a reference to the name of candidiasis. In addition, your description states the following: "[L]ot of problems with Candida which is a yeast infection. . ."
Composition Formula:
  • "[U]sed in colds, fevers, flu, hoarseness. . .cramps and stomach disorders. . ." 
Diabetic Formula:
  • The product name contains the name of a disease.
  • In addition, the description references "[C]anhelp lower blood sugar levels."
  • "Juniper berries . . .healing to the pancrease (sic), also produces natural insulin . . . Pau D' Arco has been thought to have lowered blood sugar levels in clinical studies . . ." 
Health Hormone:
  • [I]mpotency. . ."
Incontinence:
  • "[L]ack of bladder control. . .unknowingly voiding urine, urinary track (sic) infections. . ."
  • The product name contains the name of a disease. 
Joint Support:
  • "[R]elieves. . .arthritis pains. . .Support regrowth of joint tissue and cartilage reducing the need for artificial joint replacement. . ."
Mag 4:
  • "[M]ay relieve gallbladderdiscomfort. . ."
HW Formula:
  • "This product contains herbs traditionally used as a wormer . . ." 
Pain Ease:
  • "Releive (sic) for aches and pain . . ." 
R-Lung:
  • "[A]n aid to relieve irritation in the respirtory (sic) tract, lungs and bronchial, as bronchitis, allergies . . ." 
VV Formual (sic):
  • "Vericose (sic) veins can be painful . . ." 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 the FDA, as described in Section 505(a) of the Act [21 U.S.C § 355(a)]; see also Section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 LDMS Formula, Diabetic Formula, Health Hormone, Papaya LF Tea, and R-Lung products listed above are intended for treatment of one or more diseases that are not amenable to self-diagnosis and 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. Thus, 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 of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Our previous (January 9-12, 2017) inspection of your facility revealed that your firm's South Texas Botanicals Catalog # 16 also provided evidence that your products are intended for use as drugs. Thus, our observations with regard to your firm's catalog #18 are repeat observations from the January 9-12, 2017 inspection.
 
We have reviewed your response which states that revising the labeling has been an ongoing process since January 2017 and is still ongoing. This response is inadequate in that within an 11-month period the Agency would have expected to see labeling revisions published in your firm's next catalog.
 
We advise you to review your mail order catalog, product labels, and any other labeling and promotional materials for your products to ensure that the products you offer for sale do not violate the Act.
 
Adulterated Dietary Supplements
 
Even if your products did not have therapeutic claims which make them unapproved new drugs, these products, along with all your dietary supplements, would still be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been manufactured under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation in Title 21, Code of Federal Regulations, Part 111 (21 CFR part 111).
 
During the inspection of your facility, the following significant violations of these CGMP requirements were observed:
 
1.    You failed to establish specifications 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 records, as required by 21 CFR 111.70(a). Specifically,
  • You failed to establish specifications for each component that you use in the manufacture of a dietary supplement. Specifically, you failed to establish the following: an identity specification; specifications to ensure purity, strength and composition of dietary supplements manufactured using the components are met; and specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(1)-(3).
  • You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). 
We have reviewed your response letter, dated October 14, 2017. We are unable to evaluate your response because you have not provided any documentation of your corrective actions .
 
2.    Your firm's master manufacturing record failed to include at minimum, the necessary information as required by 21 CFR 111.210.
 
Specifically, your master manufacturing record (MMR) failed to contain the following:
  • A complete list of the components to be used [21 CFR 111.210(b)]. For example, your Candida Control product is labeled to contain Capsicum but your MMR doesn't list capsicum as a component.
  • Statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)].
  • Statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made, as required by 21 CFR 111.210(f).
  • Description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
  • Written instructions, including: specifications for each point, step, or stage in the manufacturing process where control is necessaryto ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; procedures for sampling; 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 master manufacturing record [21 CFR 111.210(h)(1)-(3)].
We have reviewed your response letter, dated October 14, 2017. We are unable to evaluate your response because you have not provided any documentation of your corrective actions.
 
3.    Your  batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your firm's BPRs for Candida Control, Thyroid Formula, and Revive, failed to include the following required information:
  • The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)].
  • The unique identifier that has been assigned to each component [21 CFR 111.260(d)].
  • The weight or measure of each component used [21 CFR 111.260(e)].
  • A statement of the actual yield and the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
  • Documentation, at the time of performance, of packaging and labeling operations, including an actual or representative label, or cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)]. 
In addition to establishing the specifications required in 21 CFR 111.70(e) and (g), you must also ensure your firm's BPRs document that the finished dietary supplement meets those specifications [21 CFR 111.260(i)].
 
We have reviewed your response letter, dated October 14, 2017. We are unable to evaluate your response because you have not provided any documentation of your corrective actions.
 
4.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have not established written procedures for handling product complaints (see 21 CFR 111.570(b)(1)). In addition, you must ensure product complaints are reviewed and investigated as required by 21 CFR 111.560 and written records for product complaints that are related to good manufacturing practice and subsequent investigations are maintained as required by 21 CFR 111.570(b)(2).
 
5.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, our investigator found that your firm has not collected any reserve samples of distributed products manufactured between the years of 2015 - 2017.
 
We have reviewed your response letter, dated October 14, 2017. We are unable to evaluate your response because you have not provided any documentation of your corrective actions.
 
Misbranded Dietary Supplements
 
1.    Your South Texas Botanicals brand R-Lung, Diabetic Formula, Mothers Milk Promoter, Lower Bowel Tonic, BF-N-C, Wormwood Combination, and Candida Control products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C.  § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
 
2.    Your South Texas Botanicals brand R-Lung, Diabetic Formula, Lower Bowel Tonic, Wormwood Combination, Candida Control, and BF-N-C products are misbranded within the meaning of 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36. For example, your R-Lung, Diabetic Formula, Lower Bowel Tonic, and BF-N-C products fail to declare the total weight of all other dietary ingredients contained in the "Proprietary Blend" in the Supplement Facts labels, in accordance with 21 CFR 101.36(c)(3) and must be placed on the same line to the right of the term "Proprietary Blend" or other appropriately descriptive term or fanciful name underneath the column of amounts described in paragraph (b)(2)(ii) of this section.
 
The violations cited in this letter are 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 violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your establishment is in compliance with all requirements of the Act and FDA regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may result in legal action without further notice, including, without limitation, injunction or seizure.
 
You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct violations. Include an explanation of each step taken to prevent their recurrence, as well as copies of related documents. If you cannot complete all corrective actions before you respond, explain the reason for your delay and state when you will complete the corrections.  
 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 


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