WARNING LETTER
Natural Relief Inc.
MARCS-CMS 659048 —
October 18, 2023
Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Omar F. Ashraf
Recipient Title
Owner
Natural Relief Inc.
901 State Route 541
Coshocton
,
OH
43812-9769
United States
omar.ashraf@natrelief.com
Issuing Office:
Division of Human and Animal Food Operations East V
United States
WARNING LETTER
CMS # 659048
October 18, 2023
Dear Mr. Ashraf:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 901 State Route 541 Coshocton, OH 43812-9769 from March 14, 2023- April 14, 2023. Based on our inspection, subsequent review of product labeling collected during the inspection, and review of your firm’s website, www.natrelief.com, we have identified serious 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 the FDA’s home page at http://www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website, www.natrelief.com in June 2023 and determined that you take orders for Edema NatRelief 6 and BP NatRelief 11. The claims on your website, establish that your Edema NatRelief 6 and BP NatRelief 11 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 the product webpage for Edema NatRelief 6:
“Edema NatRelief…” [Product name]
“Helps relieve mild joint inflammation and swelling”
On the product webpage for BP NatRelief 11:
“Coriander seed have been actively investigated for their chemical composition and biological activities including antimicrobial, antioxidant, hypoglycemic, hypolipidemic, anxiolytic, analgesic, anti- inflammatory, anti-convulsant and anti-cancer activities *. The seeds of coriander also have a remarkable hypolipidemic action. The levels of total cholesterol and triglycerides decreased significantly….”
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)]. With certain exceptions not applicable here, 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), 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 product BP NatRelief 11 is intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, BP NatRelief 11 fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].
Adulterated Dietary Supplements
Even if your Edema NatRelief 6 and BP NatRelief 11 products were not unapproved new drugs and misbranded drugs, these products would be adulterated dietary supplements under section 402(g)(1) of the Act. The facility inspection revealed 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 your dietary supplements to be 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 requirements for dietary supplements.
The violations include the following:
1. You failed to establish specifications for 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, as required by 21 CFR 111.70(a). Specifically, regarding your BP NatRelief 11 and Edema NatRelief 6 products:
a. For your components:
i. You failed to establish identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). For example, the ammonium chloride salt ingredient used in your Edema NatRelief 6 product and the Rauwolfia Root used in your BP NatRelief 11 product list organoleptic testing (color, odor, flavor, shape, and extraneous matters) to determine identity. Organoleptic analysis may not be an appropriate method of testing for certain substances. This is particularly true when the nature of the substance, for example powdered substances, decreases the reliability of organoleptic analysis. In addition, Rauwolfia Root may require
(b)(4)
examinations, such as
(b)(4)
examination of the
(b)(4)
to confirm its identity in addition to the bitter taste. The Rauwolfia Root may have a characteristic bitter taste; however, other plants/plant roots have bitter taste as well.
ii. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplement manufactured using the components are met, as required in 21 CFR 111.70(b)(2). For example, the component specifications you provided to our Investigator for the ammonium chloride salt used in the manufacture of your Edema NatRelief 6 product includes specifications for color, odor, flavor, and shape. The record does not contain specifications for
(b)(4)
analysis; based on the nature of the substance, that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplement using the component is met.
iii. You failed to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).
b. You failed to establish 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, as required by 21 CFR 111.70(c)(1). During the manufacture of the BP NatRelief 11 and Edema NatRelief 6 dietary supplements there is a
(b)(4)
operation of the product blend. You state the
(b)(4)
step is performed until the desired particle size is reached; however, you have not established an in-process specifications for particle size.
c. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants 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 have not established finished product specifications for the BPNatRelief 11 and Edema NatRelief 6 dietary supplement products.
Once you have established the specifications identified above, you must verify that the specifications are met in accordance 21 CFR 111.75.
We have reviewed your response dated May 5, 2023, and we are unable to evaluate your corrective action because you have not provided revised “Raw Materials Spec Sheet” for the components used in the manufacture of the BP NatRelief 11 and Edema NatRelief 6 dietary supplements, nor have you provided finished product specifications for each of the products.
2. 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 for approving or rejecting any reprocessing for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.103. Specifically, you provided a copy of the following documents “Approval Matrix and Review Period of Quality Documents,” “Responsibilities for Authorizing Master File Documents,” “Document Retention Times and Responsible Persons (All Documents),” and “Document Database for Quality Document.” The documents do not describe the responsibilities of your quality control personnel or operations. Further, they do not describe how your quality personnel conduct material reviews, how they make disposition decisions, or how they approve or reject any reprocessing.
Further, once you have established written quality control procedures, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65.
We have reviewed your response, dated May 5, 2023. Your response states a third-party consultant has been hired who will perform a gap analysis of all your processes, including quality control operations. You also state that the identified documents and procedures will be created. However, we are unable to evaluate your corrective action because you did not provide copies of your established written procedures for the responsibilities of your quality control operations for review.
3. 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 for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.205(a) and 21 CFR 111.210. Specifically, your master manufacturing record titled “Master Formula” is not prepared for a unique dietary supplement formulation and batch size.
We have reviewed your response, dated May 5, 2023. Your response states MMRs will be reviewed and revised. However, we are unable to evaluate your corrective action because you did not provide your revised master manufacturing record for review.
4. You failed to establish a batch production record (BPR) that satisfies the requirements of 21 CFR 111.255 and 111.260. For example, the BPRs for the BP Nat Relief, 11 Lot
(b)(4)
, and Edema NatRelief 6, Lot
(b)(4)
you provided to our Investigator were missing:
A statement of the percentage of theoretical yield at appropriate phases of processing as required by 21 CFR 111.260(f). Specifically, a statement of the percentage of theoretical yield was not established at the
(b)(4)
phase, and the finished dietary supplement packaging, and labeling phases for your dietary supplements.
An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR, as required by 21 CFR 111.260(k)(2).
Unique identifier assigned to packaging and labels used, as required by 21 CFR 111.260 (k)(1).
We have reviewed your response, dated May 5, 2023. Your response states you will be revising associated MMRs with the referenced BPRs. However, we are unable to evaluate your corrective action because you did not provide your revised batch production record for review.
5. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations for your BP NatRelief 11 and Edema NatRelief 6 products. Once you have established written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
We have reviewed your response, dated May 5, 2023. Your response states a third-party consultant has been hired who will analyze your firm’s operations. After this analysis, the appropriate documents and procedures will be created, including procedures related to the holding and distribution of dietary supplement products. No evidence of these corrective actions were provided.
6. You failed to establish and follow written procedures for returned dietary supplements for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.503. Specifically, you have no written procedures for returned dietary supplements.
Once have you established written procedures for your returned dietary supplements, you must make and keep records, as required by 21 CFR 111.535(b).
We have reviewed your response, dated May 5, 2023. Your response states a third-party consultant has been hired to perform a gap analysis of all your processes, including a process for tracking returns and documenting the disposal of the returned products. However, we are unable to evaluate your corrective action because you did not provide a copy of your written procedure for returned dietary supplements for review.
7. You failed to establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components of dietary supplements for your BP NatRelief 11 and Edema NatRelief 6 products, as required by 21 CFR 111.25(c). Specifically, you did not provide any documentation to support your procedures for how you maintain, clean, and sanitize the utensils used in manufacturing processes.
We have reviewed your response, dated May 5, 2023. You state you will perform a gap assessment, and your processes for cleaning, and sanitizing of all equipment, utensils and any contact surfaces will be reviewed. You also stated a cleaning system will be put into place and SOPs defining the overall control of the maintenance, cleaning, and sanitizing of equipment, utensils and any other contact surfaces will be put into place as necessary. We are unable to evaluate your corrective action because you have not provided a written procedure for how you maintain, clean, and sanitize utensils and contact surfaces.
Misbranded Dietary Supplements
In addition, even if your Edema NatRelief 6 and BP NatRelief 11 products were not unapproved new and misbranded drugs or adulterated under section 402(g)(1) of the Act, these products would be misbranded under section 403 of the Act because they do not comply with the labeling requirements for dietary supplements.
Specifically, we identified the following:
1. Your Edema NatRelief 6 and BP NatRelief 11 products are misbranded within the meaning of 21 U.S.C. § 343(q)(1)(A)] (section 403(q)(1)(A) of the Act) because the serving size declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount recommended on the label for consumption per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Your Edema NatRelief 6 and BP NatRelief 11 product labels “suggested use” and “recommendation” is declared as “1-2 capsules” but the serving size is listed as “1 Capsule.” The serving size should be declared as two (2) capsules.
2. Your Edema NatRelief 6 and BP NatRelief 11 products are misbranded within the meaning of 21 U.S.C. § 343(q)(5)(F) (section 403(q)(5)(F) of the Act) in that the presentation of nutrition information on the labeling of the products is not in accordance with 21 CFR 101.36 and 21 CFR 101.9, and 21 CFR 101.4 For example:
The title, “Supplement Facts,” is not set at full width of the nutrition label in accordance with 21 CFR 101.36(e)(1). In addition, your Edema NatRelief 6 has the title “Supplement Facts” misspelled.
Your Edema NatRelief 6 does not have the dietary ingredients indented under the title “Proprietary Herbal Blend”, in accordance with 21 CFR 101.36(c)(2).
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.
We also offer the following comments:
1. You did not follow your “Facility Sanitation” procedure in that your “Facility Cleaning Log” includes tasks such as “
(b)(4)
,
(b)(4)
” and “
(b)(4)
;” however, the “Facility Sanitation” procedure states tasks such as “
(b)(4)
,
(b)(4)
,
(b)(4)
” and “
(b)(4)
.” Your firm’s written cleaning procedures must be consistent with your firm’s practices. You also must create and maintain cleaning monitoring records.
2. You must calibrate each instrument or control that you use in the manufacturing or testing of a component or dietary supplement, as required by 21 CFR 111.27(b), and you must make and keep documentation of the calibration each time the calibration is performed, in accordance with 21 CFR 111.35(b)(3).
3. The Latin binomial name for ginger is “Zingiber officinale”, not “Zingiber officinalis” in your Edema NatRelief 6 product’s label.
4. Regarding your BP NatRelief 11 product's other ingredients statement, there is no provision in the regulation to list ingredients that a product may contain. As such, "May Contain" is considered intervening material in accordance with 21 CFR 101.2(e) in regards to this product's other ingredients list.
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 reply should be addressed to the U.S. Food and Drug Administration; Attn: Ana Morales, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 550 Main Street, Suite 4-930 Cincinnati, OH 45202. If you have any questions about this letter, please contact Ana Morales at (312) 596-4153 or via email at ana.morales@fda.hhs.gov.
/S/
Kimberly L. McMillan
Acting Program Director
Office of Human and Animal Feed
Operations Division East 5
Content current as of:
11/14/2023
Regulated Product(s)
Drugs