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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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EnerHealth Botanicals, LLC 8/8/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000              
FAX:        303-236-3100

 

August 8, 2014
 
 
VIA UPS Overnight Mail
 
WARNING LETTER
 
Ref: DEN-14-10 WL
 
 
Steve St. Clair, Owner
EnerHealth Botanicals, LLC
13720 Deere Ct
Longmont, Colorado 80504
 
 
Dear Mr. St. Clair:
 
On July 9, 10, and 12, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 13720 Deere Ct, Longmont, Colorado. During the inspection, our investigators collected label samples. We also reviewed labeling on your firm’s website at www.enerhealthbotanicals.com in July 2014. The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013 submitted in response to the FDA-483 issued to you at the close of the inspection.  We have included some detailed comments regarding your responses below.
 
Unapproved New Drug:
 
Based on our review of your product label for “Parasite Purge Herbal Remedy”, along with your website at the Internet address www.enerhealthbiologicals.com in July 2014, where you take orders there for the products “Parasite Purge Herbal Remedy,” “Black Walnut Extract,” “Bladder Cleanse Herbal Extract,” “Lung Renewal Herbal Remedy,” and “Daily Immune Support”, we have determined that these products are promoted 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 therapeutic claims on your website and product label 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 website claims that provide evidence that your products are intended for use as drugs include:
 
Parasite Purge Herbal Remedy (website)
  • Name promotes that the product will remove parasites
 
Parasite Purge Herbal Remedy (website)
  • “[V]ermicidal tincture to be used whenever a parasitic activity is suspected”
 
Black Walnut Extract  (website)
  • “[A]nti-fungal and anti-parasite”
  • “[H]erbal extract use for… other fungal issues”
 
Bladder Cleanse Herbal Extract  (website)
  • “[A]ntiseptic….”
 
Lung Renewal Herbal Remedy  (website)
  • “[W]ill aid in…clearing of the bronchials and draining excess fluids”
 
Daily Immune Support  (website)
  • “(Daily Immune Support) has been tested as an adjunct for conventional therapy for cancer, for hepatitis B, for Alcoholic liver disease, *******tested for HIV and for Hepatitis C”
 
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 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. 
 
Furthermore, your products “Parasite Purge Herbal Remedy,” “Black Walnut Extract,” “Bladder Cleanse Herbal Extract,” “Lung Renewal Herbal Remedy” and “Daily Immune Support” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
 
Adulterated Dietary Supplements:
 
Even if your “Parasite Purge Herbal Remedy,” “Black Walnut Extract,” “Bladder Cleanse Herbal Extract,” “Lung Renewal Herbal Remedy,” and “Daily Immune Support” products did not have therapeutic claims which make them unapproved new drugs, these products and all dietary supplement products that you manufacture would still be adulterated under 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 Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
 
1.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient prior to its use, unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing, as required by 21 CFR 111.75(a)(1)(i).
 
Specifically, your firm receives dietary ingredients for use in the manufacture of your finished liquid products; however, your firm did not conduct identity testing on any of these ingredients. These include, but are not limited to the following dietary ingredients: Echinacea, Osha, Yerba Mansa, St. John’s wort, Usnea, and Licorice used in your “EchinOsha” product; Elecampane, Mullein, Osha, Yerba Mansa, Yerba Santa, Dandelion, and Lobelia in your “Lung Renewal Herbal Remedy” product; and Milk Thistle, Turmeric, Oregon Grape, Dandelion, Fennel Seed, and Licorice in your “Liver Cleanse” product.
 
Your firm did not have identity test results, records of testing, or any other examinations/test records for any ingredients used in your finished liquid products. Without identity testing of your ingredients, you cannot determine whether the specifications for the composition of dietary supplements manufactured are met.
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013. Your responses indicate that you will conduct a (b)(4) analysis examination of dietary ingredients under 21 CFR 111.75(h)(2) (b)(4). You also stated that a visual comparison will be made to the “standard” and that photographs will be taken and retained for records. You also indicated that you will fill out an identity test document and you intend to create an “in-house” Certificate of Analysis (C of A) based on this identity testing to be performed on all incoming ingredients. Your responses are inadequate in that you did not provide records that demonstrate this type of examination on your dietary ingredients for our review to determine its adequacy. Further, your reference standard of a reference book appears inadequate when used to compare a wildcrafted plant or plant powder. You did not explain how you can ascertain macroscopic characteristics of the plant or histologic analysis of the specimen using a reference book as opposed to a voucher or authenticated reference material. You also did not explain how you can distinguish one plant from another just based on the visual appearance, color, odor, flavor, and extraneous matter present on the plant.  
 
2.    You failed to establish the following specifications required by 21 CFR 111.70:
 
  • Identity specifications for each component that you use in the manufacture of a dietary supplement [21 CFR 111.70(b)(1)];
  • Product specifications for each dietary supplement 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 [21 CFR 111.70(e)];
  • Packaging and labeling specifications for the finished packaged and labeled dietary supplements, including specifications to ensure that you use the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
 
Specifically, you have not established the above specifications for any of the dietary supplement products that you manufacture.
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013. We have determined that the responses are inadequate. You stated in your first response letter “[p]roduct specifications will be established for the ‘identity, purity, strength, and composition of finished dietary supplement…[s]ince we have over (b)(4) different ‘finished products’ implementation is a work in progress…[w] anticipate completion (sic) by (b)(4).” However, your second response did not contain specifications for your finished products. Furthermore, you stated in your first response “(b)(4) testing of finished product will be conducted.” Please be advised that it is not possible to verify the identity, purity, strength or composition by “(b)(4) testing.” In addition, it is not possible to determine the absence of contaminants that may adulterate your product by (b)(4) means.
 
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 written procedures for approving or rejecting any reprocessing, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Furthermore, your quality control personnel failed to ensure that your manufacturing, labeling, and holding operations ensure the quality of the dietary supplement, as required by 21 CFR 111.105. Specifically, your firm has not established written procedures for quality control responsibilities and does not have designated quality control personnel to ensure that your manufacturing, labeling, and holding operations ensure the quality of your dietary supplements.
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013, and we have determined that the responses are inadequate. Your responses indicated that quality control responsibilities have been established. However, you did not provide any written procedures for the responsibilities for the quality control operations for our review. Additionally, you indicated you have implemented some of the quality control requirements under 21 CFR 111.105, 21 CFR 111.120, 21 CFR 111.123, and 21 CFR 111.510. Specifically, you recited the requirements under 21 CFR 111.105(a), (b), (c), (d), (f), (g) and 21 CFR 111.123(a)(8), 21 CFR 111.510, 21 CFR 111.123(a) and 21 CFR 111.120(e). However,  you did not provide specific details documenting these operations.
 
4.    You failed to prepare and follow 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 did not prepare MMRs for each unique batch size for the approximately 160 liquid dietary supplement products manufactured at your firm, including, but not limited to your “EchinOsha,” “Liver Cleanse” and “Lung Renewal Herbal Remedy” products. Additionally, your firm did not prepare a MMR for “Daily Immune Support,” a dietary supplement in caplet form that is bottled and labeled by your firm for distribution, to ensure that the dietary supplement is packaged and labeled as specified in the MMR (see 21 CFR 111.205(b)(1)). The MMR must include a description of packaging and a representative label as required by 21 CFR 111.210(g).
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013. Your responses indicate that you are in the process of preparing MMRs for your products. With the exception of your “Alfalfa Leaf” product, however, you did not provide MMRs for our review. A review of the MMR for your “Alfalfa Leaf” product revealed that the following information was not included:
 
  • The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement as required under 21 CFR 111.210(d).
  • A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label as required under 21 CFR 111.210(g).
 
5.    Written instructions, as required under 21 CFR 111.210(h), including specifications for each point, step, or stage in manufacturing process where control is necessary to ensure the quality of the dietary supplement; procedures for sampling and a cross-reference to procedures for tests or examinations; 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; and corrective action plans for use when a specification is not met. 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, the batch production records for the following products, “EchinOsha” (b)(4), “Liver Cleanse” (b)(4), and “Lung Renewal Herbal Remedy” (b)(4), were missing the following information:
 
  • The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
  • 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)];
  • A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
  • The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
  • The results of any testing or examination performed during the batch production, or cross-reference to such results [21 CFR 111.260(h)];
  • Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
  • Documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)];
  • Documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)].
  • Documentation, at the time of performance, that quality control personnel reviewed the batch production record [21 CFR 111.260(l)(1)].
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013and we have determined that the responses are inadequate.  Your responses did not include any batch records for our review that demonstrate that you have implemented the above-referenced requirements.
 
6.    Your firm did not 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).
 
For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].
 
We have reviewed your first undated written response received on August 5, 2013 and the second written response dated October 31, 2013. Your responses indicate that you will collect samples for each lot of finished product that is packaged and labeled and retain them for 2 years after the date of distribution. You also indicated the amounts you would collect for the liquid dietary supplements (herbal tinctures) and the “Daily Immune Support” products. We will verify the adequacy of this correction during any future inspection.  
 
7.    You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. 
 
8.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.
 
9.    You failed to establish and follow written procedures for handling returned dietary supplements, as required by 21 CFR 111.503.
 
10.    You failed to establish written procedures for the review and investigation of product complaints, as required by 21 CFR 111.553. 
 
Misbranded Dietary Supplements:
 
Even if your “Daily Immune Support” and “Lung Renewal Herbal Remedy” were not unapproved new drugs, they would still be misbranded foods within the meaning of section 403 of the Act [21 U.S.C.§ 343]. Further, your “EchinOsha,” and “Liver Cleanse” products are misbranded within the meaning of section 403 of the Act. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.    Your “EchinOsha,” “Lung Renewal Herbal Remedy,” “Liver Cleanse”, and “Daily Immune Support” products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the 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.
 
2.    Your “EchinOsha,” “Lung Renewal Herbal Remedy,” and “Liver Cleanse” 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 labels fail to bear nutrition labeling in the form of a “Supplement Facts” label in accordance with 21 CFR 101.36.
 
3.    Your “Daily Immune Support” product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label declares botanical ingredients but fails to identify the part of the plant from which the botanical ingredients are derived in accordance with 21 CFR 101.4(h)(1). Specifically, the label fails to declare the part of the plant from which “Agaricus blazei,” “Cordyceps sinensis,” Grifola Frondosa,” “Ganoderma Lucidum,” “Coriolus Versicolor,” and “Lenitula Edodes” are derived.
 
4.    Your “Daily Immune Support” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the label fails to declare the ingredients used to make the caplet (e.g., excipients, fillers, binders) preceded by the word “Ingredients,” in accordance with 21 CFR 101.4(g).
 
This letter is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that your establishment and all of your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter and to prevent their recurrence. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including seizure and/or 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 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.
 
Please respond to this office in writing within 15 working days from your receipt of this letter with the actions you plan to take to correct the violations noted above. Your response should include any documentation that would assist us in evaluating your corrections. If you cannot complete the corrective actions within 15 working days, state the reason for the delay and the date by which you will complete the corrections.
 
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, Food and Drug Administration, P.O. Box 25087 (Bldg. 20, Denver Federal Center, 6th Avenue and Kipling Street), Denver, CO 80225-0087. If you have any questions regarding any issue in this letter, please contact Ms. Pinney at (303) 236-3024 or via email at carolyn.pinney@fda.hhs.gov.
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Denver District Director