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WARNING LETTER

HoneyCombs Industries, LLC


Recipient:
HoneyCombs Industries, LLC


United States

Issuing Office:
Denver District Office

United States


  

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

 

February 24, 2016
 
 
VIA UPS Overnight Mail
 
WARNING LETTER
 
Ref: DEN-16-06-WL
 
 
Mrs. Jacqueline M. Huff, General Manager
HoneyCombs Industries, LLC.
10671 6075 Road
Montrose, Colorado 81403
 
 
Dear Mrs. Huff:
 
On July 7-10, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 10671 6075 Road, Montrose, Colorado. During the inspection FDA collected product labeling. Additionally, FDA subsequently reviewed your website at the Internet address www.honeycombsindustries.com. Based on our inspection and review of your product labeling, including 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 FDA regulations through links on FDA’s home page at www.fda.gov
 
Unapproved New Drugs:
 
The FDA reviewed your website at the Internet address www.honeycombsindustries.com in January 2016 and has determined that you take orders there for the products Cough Syrup, Formula C&F (Cold & Flu) Liquid Alcohol Free Extract, Month 6 (Parasites & Microbes), and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract. Additionally, the FDA has reviewed your product label for your Cough Syrup product obtained during the July inspection of your facility. The claims on your website and product label establish that the above-mentioned products are drugs under 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 claims on your Cough Syrup product label that provide evidence that your product is intended for use as a drug include:
 
Cough Syrup
  • The name of your product, “Cough Syrup.”
  • “Suggested Use…as needed for coughing and congestion.”
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Cough Syrup 
  • The name of your product, “Cough Syrup.”
Formula C&F (Cold & Flu) Liquid Alcohol Free Extract
  • The name of your product, “Formula C&F (Cold & Flu)…” 
Month 6 (Parasites & Microbes) 
  • The name of your product, “… (Parasites & Microbes).”
Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract
  • The name of your product, “Formula P (Parasites…”
Your 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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating 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 Month 6 (Parasites & Microbes) and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract 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, Month 6 (Parasites & Microbes) and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract 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)].
 
Adulterated Dietary Supplements
 
Even if your Cough Syrup, Formula C&F (Cold & Flu) Liquid Alcohol Free Extract, Month 6 (Parasites & Microbes), and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract products did not have therapeutic claims which make them unapproved new drugs, those products and any other dietary supplement products that you manufacture would 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 prepared, packed, or held under conditions that do not meet the current good manufacturing practice (cGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
The following significant violations were documented during the inspection: 
 
1.    You failed to establish specifications as required by 21 CFR 111.70 as follows:
 
o   Component specifications for identity, purity, strength, composition, and limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of dietary supplements, as required by 21 CFR 111.70(b). Specifically, you stated during the inspection that you had not established any component specifications and there were no component specifications listed in your firm’s Master Manufacturing Records (MMR);
 
o   In-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplement and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1). Specifically, there were no in-process specifications listed in your firm’s MMR;
 
o   Specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements [21 CFR 111.70(d)]. Specifically, there were no specifications for dietary supplement labels or packaging listed in your firm’s MMR;
 
o   Product specifications 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 may lead to adulteration of the finished batch of dietary supplements, as required by 21 CFR 111.70(e). Specifically, you stated during the inspection that you had not established any finished product specifications and there were no finished product specifications listed in your firm’s MMR.
 
Once you have established specifications, it is your responsibility to verify that specifications are met in accordance with 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records in accordance with 21 CFR 111.95(b).
 
We have reviewed your response received on August 14, 2015. You provided a (b)(4) window for establishing specifications for purity, strength, and composition and identifying limits of contamination for each of your (b)(4) components.  Because your response did not include any documentation that you have created any of the specifications noted above as missing, nor did it address your plans for product manufactured and/or marketed while corrections were being implemented, we cannot assess the adequacy of your corrective actions.
 
2.    You failed to maintain documentation of how you qualified a supplier of a component of dietary supplement products, as required by 21 CFR 111.75(a)(2)(ii)(C). Specifically, you relied on a supplier’s COA for the component, (b)(4) (Lot (b)(4)), used in several dietary supplement products that you manufacture and distribute, including Golden Seal Extract and Formula E. However, you were unable to provide documentation for the qualification of your supplier for this component as required by 21 CFR 111.75(a)(2)(ii)(C).
 
We have reviewed your response dated August 14, 2015 in which you stated that you have started the process of confirming the reliability of your suppliers COAs through contract with a third-party laboratory; however, we are unable to determine the adequacy of your corrective actions because you did not supply any supporting documentation.
 
3.    You failed to include in your written MMR, 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, as required by 21 CFR 111.210(h)(3). Specifically, you do not list in your MMRs, for any of the dietary supplements that you manufacture, specific actions necessary for verifying the weight or measure of any component and verifying the addition of any component. For manual operations, such specific actions must include:
  • One person weighing or measuring a component and another person verifying the weight or measure; and,
  • One person adding the component and another person verifying the addition.
Without listing specifications in the MMR for the steps in the manufacturing process where control is necessary, you cannot ensure the quality of your dietary supplements.
 
In addition, the MMR must include the following:
  • A statement of any intentional overage amount of a dietary ingredient as required by 21 CFR 111.210(e).
  • A description of packaging and a representative label as required by 21 CFR 111.210(g).
We have reviewed your response received on August 14, 2015. You stated that you are in the process of rewriting all the MMR’s and that this process will take (b)(4) to complete for the 100 products you manufacture.  Your response did not include any documentation that you are in the process of establishing written master records to ensure uniformity in the finished batch. It also does not address whether you will continue to make dietary supplements before you have established MMRs. Therefore, we cannot assess the adequacy of your corrective actions.
 
4.    You failed to prepare a written batch production record (BPR) for each unique formulation of dietary supplement that you manufacture [21 CFR 111.255]. Furthermore, you failed to document required information in your BPRs for any batch records you prepared, as required by 21 CFR 111.260. Specifically, you stated that your firm did not keep such detailed records but instead keeps batch logs that include the (b)(4). Records with the information required for each batch manufactured were not available.
 
We have reviewed your written response received on August 14, 2015; however, we are unable to determine the adequacy of your corrective actions because you failed to provide any supporting documentation.
 
5.    Your firm failed to establish written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. Specifically, you stated during the inspection that you did not have any written procedures for quality control operations and our investigators did not find any such records. 
 
We have reviewed your written response received on August 14, 2015; however, we are unable to determine the adequacy of your corrective actions because you failed to provide any supporting documentation.
 
6.    You did not establish written procedures for maintaining, cleaning and sanitizing, as necessary, all equipment, utensils and other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c). Furthermore, you do not routinely document in individual equipment logs the date of use, maintenance, cleaning, and sanitizing of equipment as required by 21 CFR 111.35(b)(2).
 
We have reviewed your written response received on August 14, 2015. You stated that cleaning and sanitizing operations have been established but you did not have a record of them. In addition, you stated that it would take (b)(4) to have these procedures written. Because you did not provide any written procedures for our review, we are unable to determine the adequacy of your corrective actions.
 
7.    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 written response received on August 14, 2015.  You state that you have collected all current labeled reserve samples and they are being held. However, you did not state how long you intend to hold these reserve samples of finished product. Therefore, we cannot assess the adequacy of your corrective actions
 
8.    Your firm failed to assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement as required by 21 CFR 111.415(f)(1). Specifically, your firm does not include a batch, lot, or control number on the packaging or labeling of dietary supplement products.
 
We have reviewed your written response received on August 14, 2015; however, we are unable to determine the adequacy of your corrective actions because you failed to provide any supporting documentation.
 
Misbranded Dietary Supplements
 
Your Golden Seal Extract, Black Cohosh, and Formula E dietary supplement products are misbranded within the meaning of section 403(s)(2)(B) [21 U.S.C. § 343(s)(2)(B)] because their labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g). Further, even if your Cough Syrup product was not an unapproved drug, it would also be misbranded for the same reason.
 
This letter is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
 
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 
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 advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that corrections have been achieved. If you cannot complete all corrections before you respond, 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