WARNING LETTER
Restorative Botanicals, LLC
MARCS-CMS 674740 —
August 13, 2024
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Dietary Supplements
Recipient:
Recipient Name
Bernard T. Perry
Recipient Title
President
Restorative Botanicals, LLC
1820 Industrial Cir Unit B
Longmont
,
CO
80501
United States
bperry@restorativebotanicals.com
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
August 13, 2024
WARNING LETTER
Ref: CMS Case # 674740
Dear Mr. Perry:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1820 Industrial Circle, Unit B, Longmont, CO, from November 27 through December 12, 2023. Based on inspectional findings, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the conclusion of the inspection on December 12, 2023, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We received written responses from you dated January 3, April 12, April 25, May 9, and June 28, 2024, to the FDA 483. We address your responses below, in relation to each of the noted violations.
Adulterated Dietary Supplements
The inspection of your facility on November 27 to December 12, 2023, identified serious violations of the 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 My GUT Shrooms Gummies 60 ct. and My IMMUNE Shrooms Capsules 60 ct. dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 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.
Your significant violations of the CGMP requirements are as follows:
1. You failed to establish component specifications for each component that you use in the manufacturing of a dietary supplement as follows:
You failed to establish an identity specification for each component that you used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, you failed to establish an identity specification for every ingredient that includes a test method that will adequately identify the component.
We reviewed your firm’s January 3, 2024, April 12, 2024, April 25, 2024, May 9, 2024, and June 28, 2024, responses to the FDA 483. In your April 12, 2024, response, you provided component specifications for each component that you use to manufacture your My GUT Shrooms Gummy and My IMMUNE Shrooms Capsule finished products. However, we note that certain components (e.g., Organic Chaga Extract, Organic Maitake Extract, Organic Agaricus Blazei Extract, etc.) rely solely on the physical characteristics listed (e.g., color, smell, taste) for identification purposes. Organoleptic specifications are not appropriate to confirm the identity of each component in this case due to the physical similarities of certain components. For example, the specifications for Organic Maitake Extract and the Organic Agaricus Blazei Extract state that both are “yellow to brown” powders and the specification for the Organic Chaga Extract states that it is a “brown to black” powder, meaning that all three extracts may appear to be brown powders.
You failed to establish 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)(3). Specifically, you failed to provide toxic element specifications for each of your mushroom components. Mushroom components, due to their common growing conditions, are at high risk for the accumulation of toxic elements.
We reviewed your firm’s January 3, 2024, April 12, 2024, April 25, 2024, May 9, 2024, and June 28, 2024, responses to the FDA 483. In your April 12, 2024, response, you provided component specifications for each component that you use to manufacture your My GUT Shrooms Gummy and My IMMUNE Shrooms Capsule finished products. We note that although all of your component specifications included microbial limits, you failed to provide toxic element specifications for each of your mushroom components.
For each specification that you are required to establish, you must take specific actions, after they are established, to verify that the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75. You must also ensure that 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 in accordance with 21 CFR 111.95.
2. You failed to, for each dietary supplement that you manufacture, establish product specifications for the identity 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, your My GUT Shrooms Gummy and My IMMUNE Shrooms Capsule finished dietary supplement products are lacking adequate identity and limits of contaminants specifications.
We reviewed your firm’s January 3, 2024, April 12, 2024, April 25, 2024, May 9, 2024, and June 28, 2024 responses to the FDA 483. In your April 25, 2024, and May 9, 2024 responses, you provided finished product specifications for your My IMMUNE Shrooms Capsule and My GUT Shrooms Gummy finished dietary supplement products, respectively. Your finished product specifications rely on
(b)(4)
. However,
(b)(4)
testing is not an adequate test method to identify your multi-component botanical finished products because of the number of ingredients in your finished products. More specifically, the overlying
(b)(4)
from all of the components will lead to overlapping component spectra that result in an indistinguishable finished product spectrum. Additionally, you provided specifications for the limits for microbial contaminants but failed to provide specifications for the limits for toxic elements for your finished products.
For each specification that you are required to establish, you must take specific actions, after they are established, to verify that the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75. You must also ensure that 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, in accordance with 21 CFR 111.95.
3. Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.105. Specifically, your MMR for My GUT Shrooms Gummies directs you to the components listed in the relevant batch production record (BPR), but the components listed in the BPR do not match the components listed on the dietary supplement product label. Your BPR for your product My GUT Shrooms Gummies 60 ct. lists the ingredients Sugar 1,
(b)(4)
and
(b)(4)
Color; however, the
(b)(4)
color ingredient is not listed on the label for this product, and the ingredients list on the label only lists one sugar ingredient.
4. You failed to prepare and follow a written 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).
We reviewed your firm’s January 3, 2024, April 12, 2024, April 25, 2024, May 9, 2024, and June 28, 2024 responses to the FDA 483. Your responses do not adequately address the violation. Specifically, your MMRs for your My GUT Shrooms Gummy and My IMMUNE Shrooms Capsule finished products, which were provided in your April 12, 2024, response, are not specific to the batch size being manufactured, as required by 21 CFR 111.205(a).
5. Your BPRs failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). Specifically, your BPRs failed to include all of the required information under 21 CFR 111.260.
We reviewed your firm’s January 3, 2024, April 12, 2024, April 25, 2024, May 9, 2024, and June 28, 2024 responses to the FDA 483. In your April 12, 2024, response to the FDA 483, you provided revised, partially executed BPRs for your My GUT Shrooms Gummy and My IMMUNE Shrooms Capsule finished dietary supplement products. However, your BPRs failed to include actual or representative labels, or a cross-reference to the physical location of the actual or representative labels, as required by 21 CFR 111.260(k)(2). For example, the label provided in your BPR for My GUT Shrooms Gummies is incomplete and lacking the Supplement Facts label and is therefore not representative of the full product label.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087. Refer to Unique Identification Number CMS #674740 when replying. You may reach Ms. Tormey at Kathleen.tormey@fda.hhs.gov or (303) 236-3137 if you have any questions about this matter.
Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4
Content current as of:
09/24/2024
Regulated Product(s)
Dietary Supplements