Editor's Note
FDA sent this warning letter to PRI Inc for alleged cGMP violations and therapeutic claims that cause FDA to consider the company's dietary supplement products to be adulterated. The company responded to inspector observations by outlining corrective actions, but FDA said it is unable to evaluate the adequacy of these actions because the company failed to provide adequate documentation. The warning letter provides several examples of online claims that promote products to cure, mitigate, treat, or prevent disease, including: "clear the lungs and congestion;" "antibiotic/antiseptic;" "help overcome Lyme disease;" and "helps ease ligament laxity."
June 5, 2019
Food and Drug Administration

The U.S. Food and Drug Administration (FDA) inspected your facility at 84 West Fourth Avenue, Lobelville, Tennessee, on October 16-17, 19, 22, and 26, 2018. The inspection revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Additionally, during the inspection of your facility, our investigator collected labels for your dietary supplements. Based on a review of your product labels collected during the inspection and a subsequent review of your website at the internet address www.forestcenterherbs.com , we have identified serious violations of the Act and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at  http://www.fda.gov .

We have reviewed your response, received November 6, 2018, and we address your response below.

Unapproved New / Misbranded Drugs

We reviewed your website at the Internet address www.forestcenterherbs.com in April 2019, and we have determined that you take orders there for your SpiroNIL, General Formula, Black Walnut, Alfalfa Herbal Tonic, Kidney Formula #1, Kidney Formula #2, and MicroNIL products. The claims on your website establish that these 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 website claims that provide evidence that your products are intended for use as drugs include:

On your webpage titled, “MicroNIL – ‘The Herbal Sledgehammer’”:
MicroNIL
  • “[Elecampane] has tremendous properties to clear the lungs and congestion.” Elecampane is an ingredient in MicroNIL.
  • “So those things combined in MicroNil all together are probably the best broad-acting herbal substance I know to act as a natural herbal antibiotic/antiseptic.”

On your website download from your “Forest Center Herbs” home page, titled, “‘Global’ Healing with WIDE-USE HERBALS”:
SpiroNIL
  • “Teasel root concentrate [an ingredient] to counter CNTI [Chronic Neurotoxin Mediated Illness] and help overcome Lyme disease.”
  • “Teasel root concentrate [an ingredient] helps ease ligament laxity and counter the effects of neurotoxins found in Lyme disease.”

General Formula
  • “Can be useful in the management of enteric ulceration.”
  • “Can assist in arresting the progression of deep seated pathologies.”
  • “Very effective in assisting the eradication of Helicobacter pylori.”

Black Walnut
  • “[A]nti-parasite characteristics”

Alfalfa Herbal Tonic
  • “[A]lfalfa based multi-herb formula effective at expelling joint toxins & reducing joint inflammation.”

Kidney Formula #1
  • “This [Kidney Formula #1] is often the best initial remedy to use in cases of significant kidney dysfunction or pathology.”

Kidney Formula #2
  • “An outstanding Goldenrod/Buchu based formula (stronger than Kidney #1) which often has the ability to assist elimination of mild to moderate cystitis.”

Your SpiroNIL, General Formula, Black Walnut, Alfalfa Herbal Tonic, Kidney Formula #1, Kidney Formula #2, and MicroNIL products are not generally recognized as safe and effective for the above referenced uses and, therefore, they 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” mean 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 General Formula, SpiroNIL, and Kidney Formula #2 products are intended for prevention or 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 purpose. Accordingly, General Formula, SpiroNIL, and Kidney Formula #2 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

Your dietary supplements are 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 CGMP regulations for dietary supplements, 21 CFR Part 111. Additionally, even if your product labeling did not have therapeutic claims that make your SpiroNIL, General Formula, Black Walnut, Alfalfa Herbal Tonic, Kidney Formula #1, Kidney Formula #2, and MicroNIL products unapproved new and/or misbranded drugs, they would still be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act. The significant violations are as follows:

1. You did not establish product 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 to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you did not have finished product specifications for any of your FlorAlive and Forest Center Herbs brand-name dietary supplement products.

We have reviewed your response received November 6, 2018, in which you provided templates for Botanical and Non-Botanical Products Sheets as examples of how you will attempt to implement standardized specifications for products going forward.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you have established finished product specifications for identity, purity, strength, composition, and limits for contaminants for the dietary supplements that you manufacture.

Once you have established the specifications as required by 21 CFR 111.70(e), you must take specific actions to determine whether the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75. You must also ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of all activities relating to such specifications, in accordance with 21 CFR 111.95(b)(1).

2. You did not establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g). Specifically, your firm did not establish packaging and labeling specifications for finished dietary supplements. Once you have established such specifications, you must, at a minimum, as required by 21 CFR 111.75(g), conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label.

We have reviewed your response received November 6, 2018, in which you stated the following:

PRL will begin the process of compiling individual Product Data Sheets within (b)(4) days, and we will prioritize the individual products from the top of our manufacturing schedule. Given that we do not manufacture all available products (b)(4), we anticipate the implementation process to take (b)(4) before completion. 

We cannot evaluate the adequacy of the response because you did not provide documentation of an executed document to show you are now in compliance with the requirement to have established specifications for the packaging and labeling of finished packaged and labeled dietary supplements.

3.   You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient before use in the manufacture of your dietary supplement products, as required by 21 CFR 111.75(a)(1)(i). Additionally, for components other than dietary ingredients, you failed to either conduct appropriate tests or examinations to confirm the identity of these components or establish the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2). Specifically, during the inspection, you stated that your firm relies on supplier certificates of analysis for raw materials, including raw dietary ingredients, because your firm does not test raw materials for purity, strength, composition, and limits on contaminants. You also stated that your firm does not perform supplier audits or supplier qualifications. Furthermore, water sourced from a private well was used as a component in the manufacture of your Kidney Formula #1 and SpiroNIL products; during the inspection you stated that you neither test the water prior to use nor rely on third-party testing to confirm the identity of this component.

We have reviewed your response received November 6, 2018. You state that you plan to purchase materials that will enable you to test your manufacturing inputs. You also stated that you will immediately begin tracking all shipments of water between the Forest Center Herbs (FCH) Farm and PRL’s manufacturing facility, and that you will begin a regular water testing regimen.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you are testing your dietary ingredients prior to use or relying on certificates of analysis from qualified suppliers for non-dietary ingredient components.   
 
4. Your quality control personnel did not approve or reject written procedures that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, during the inspection we reviewed the standard operating procedures for the production and process control system for the batch records for your dietary supplements, and none included a signature from your quality assurance personnel.
 
We have reviewed your response received November 6, 2018. You stated that your firm “will begin documenting an annual quality review and approval process that encompasses all 38 Standard Operating Procedures.” We cannot evaluate the adequacy of the response  because you did not provide documentation to support that your quality control unit is reviewing and approving your written procedures.
 
5. Your master manufacturing record failed to include all required information, in accordance with 21 CFR 111.210. Specifically, the master manufacturing record used in the production of your Boldo dietary supplement Lot E1329318 fails to include the following information:
  • 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 [21 CFR 111.210(d)];
  • A representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)];
  • Procedure for sampling for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
  • Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].

We have reviewed your response received November 6, 2018. You stated that you will amend your form to include a photo of the label used.  We cannot evaluate the adequacy of the response because you did not provide documentation to support that you revised your master manufacturing record and that it is compliant with 21 CFR 111.210.

6. Your batch production records (BPR) failed to include all required information, in accordance with 21 CFR 111.260. Specifically, your BPR for Kidney Formula #1 Lot S2321818 fails to include the following information:
  • The identity of the equipment and processing lines used in producing the batch [see 21 CFR 111.260(b)];
  • The actual results obtained during any monitoring operation [see 21 CFR 111.260(g)];
  • Documentation, at the time of performance, of the date on which each step of the master manufacturing record was performed [see 21 CFR 111.260(j)(1)];
  • Documentation, at the time of performance, of packaging and labeling operations including the unique identifier assigned to packaging and labels used [see 21 CFR 111.260(k)(1)];
  • Documentation at the time of performance that quality control reviewed the BPR [see 21 CFR 111.260(l)(1)].

We have reviewed your response received November 6, 2018. You state that you will amend your forms “to include explicit checklists for the maintenance, cleaning, and sanitation functions associated with the equipment used in producing, blending, or bottling a given batch.”  We cannot evaluate the adequacy of the response because you have not provided a revised, executed BPR for review. 

7. You failed to calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b). Specifically, your firm did not routinely calibrate the raw materials scale used to measure dry materials or document calibration of this scale. You must calibrate:
  • Before first use [21 CFR 111.27(b)(1)];
  • At the frequency specified in writing by the manufacturer of the instrument and control [21 CFR 111.27(b)(2)];
  • At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control [21 CFR 111.27(b)(3)].

We have reviewed your response received November 6, 2018. You stated that you will amend your forms to include a calibration checklist for the raw materials scale. We cannot evaluate the adequacy of the responsebecause you have not provided evidence that you are calibrating your instruments and controls as required.
 
8. You failed to control the issuance and use of labels, as required by 21 CFR 111.410(b). Specifically, you do not document the status of received labels (quarantined, approved, or rejected).
 
We have reviewed your response received November 6, 2018. You state that you will begin documenting the process of reviewing labels.  We cannot evaluate the adequacy of the response because you did not provide records to support that you are documenting label usage and performing label reconciliation of your dietary supplement labeling operations.
 
This is a repeat observation from the November 4-5, 2015, FDA inspection.
 
9. You failed to make and keep records of the results of any test or examinations conducted on packaging or labels and of any visual examination of product that you receive for packaging or labeling as a dietary supplement and any material review and disposition decision on components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement [21 CFR 111.180(b)(3)]. Specifically, during the inspection you stated that a form does not exist for the incoming receipt and inspection of packaging and labels. At a minimum, you must document that you visually examined each immediate container or grouping of immediate containers in a shipment for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the packaging and labels, as required by 21 CFR 111.160(a).
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or 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 all requirements of federal law, including FDA regulations. You should take prompt action to correct the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

In addition, we have the following comments: 
  • During the inspection we reviewed the labels for two products you manufacture under the brand name “HeavenSent Hemp.” These products are CHT+ Colloidal Hemp Terpenes plus and Organic Mint Chocolate Hemp Extract. It is unclear whether you intend to market these products as conventional foods or as dietary supplements. For example, your Organic Mint Chocolate Hemp Extract product bears a label titled “Food Supplement Facts.” We note that conventional foods must be labeled with “Nutrition Facts” in accordance with 21 CFR 101.9, and dietary supplements must be labeled with “Supplement Facts” in accordance with 21 CFR 101.36. Additionally, from the labels, it is unclear if these are cannabidiol (CBD) products. FDA has stated that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added. FDA has further stated that CBD products cannot be sold as dietary supplements. These statements, along with additional information about FDA regulation of cannabis-derived products, are available on our webpage:https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm.
  • Your Kidney Formula #1 product label does not list the name of each dietary ingredient and the quantity of each such dietary ingredient, as required by 21 CFR 101.4 and 101.36. The batch production record for your Kidney Formula #1 states that the product contains an herb or other botanical ingredient which is an extract from the Joe-Pye Weed (Fresh Plant Material). However, you do not list this botanical ingredient or its quantitative amount by weight per serving in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

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 mean 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.