From September 13 through September 18, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement, conventional food, and drug manufacturing facility located at 904 West Pine Grove Road. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Additionally, your Yoder’s Good Health Recipe product is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it bears or contains unsafe food additives in accordance with section 409 of the Act [21 USC 348]. Further, a review of your product labels collected during the inspection, and a review of your website at http://yoderstore.com, identified serious violations of the Act and applicable regulations. You can find copies of the Act and pertinent regulations through links on FDA’s homepage at
www.fda.gov
.
Unapproved New Drugs
FDA reviewed your labeling and has determined that you take orders there for the products Yoder’s brand Respiratory & Cough Formula, and Life Drops. The claims on your labeling establish that the 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 that provide evidence that your products are intended for use as drugs include the following:
Life Drops
- “This unique formula . . . fights . . . inflammation”
Yoder’s brand Respiratory & Cough Formula
- “[D]ose can be mixed with raw honey and used as a cough syrup.”
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)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally marketed in the United States 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 based on scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
Adulterated Dietary Supplements
Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been held under conditions that do not meet the CGMP regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Additionally, even if your Yoder’s brand Respiratory & Cough Formula and Life Drops products did not have therapeutic claims which make them unapproved new drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)]. We acknowledge your written response letter, dated October 5, 2017, to the FORM FDA 483, Inspectional Observations, issued to you after the inspection on September 18, 2017. Our comments regarding your corrective actions, as applicable to the violations noted below, are indicated. The significant violations include, but may not be limited to, the following:
1. Your firm failed to confirm the identity of components that are not dietary ingredients and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Under 21 CFR 111.75(a)(2), you must either conduct appropriate tests or examinations to confirm the identity of such components, or you must rely on a certificate of analysis (COA) from the supplier of the component after you have, among other requirements, qualified the supplier by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s tests or examinations. You do not conduct tests or examinations to confirm the identity of components in your dietary supplements, and you have not qualified your supplier of a component by establishing the reliability of the supplier's COA through confirmation of the results of the supplier’s tests or examinations.
We have reviewed your response letter, dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your response states that a supplier verification process will be implemented and record keeping process established. However, you did not provide supporting documentation with your response.
2. Your firm 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, as required by 21 CFR 111.103. Specifically, you have no written procedures for the responsibilities of the quality control operations. Additionally, your firm failed to identify who is responsible for your quality control operations, as required by 21 CFR 111.12(b). Once you have identified an individual or individuals responsible for your quality control operations, you must ensure that such person or persons have been qualified through education, training, or experience to perform any quality control operations, as required by 21 CFR 111.12(c). You must have quality control personnel to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as required.
We have reviewed your response letter dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your response states that this observation will be addressed “through the Standardized Training Curriculum of the FSPCA PCQI Preventive Controls Qualified Individual Training week of 10/9/2017.” You did not provide any additional supporting documentation to confirm enrollment in such training, nor have you since provided confirmation that the indicated training has been completed by personnel at your firm. Moreover, even if the appropriate person(s) at your firm have received such training, the principles must be implemented by your firm. It remains your responsibility to ensure that your firm is following the requirements outlined in the dietary supplement regulation found at 21 CFR Part 111.
3. Your firm 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. Specifically, you have not prepared a written MMR for each unique formulation of dietary supplement you manufacture and for each batch size.
We have reviewed your response letter dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your response states that you will “create batch reporting and master manufacturing records for each finished batch of herbal supplements.” However, you did not provide supporting documentation with your response, such as a copy of a written MMR for each unique formulation and for each batch size of dietary supplement.
4. Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch of dietary supplement you manufacture, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPRs for the dietary supplements you manufacture failed to include the following required information:
a. The batch, lot, or control number of the finished batch of dietary supplement [21 CFR 111.260(a)(1)];
b. The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
c. 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)];
d. The unique identifier that you assigned to each component (or when applicable, to the product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used [21 CFR 111.260(d)];
e. The identity and weight or measure of each component used [21 CFR 111.260(e)];
f. A statement of the actual yield and statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
g. The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
h. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
i. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
j. Documentation, at the time of performance, of the manufacture of the batch, including:
- The date on which each step of the master manufacturing record was performed [21 CFR 111.260(j)(1)]; and
- The initials of the persons performing each step, including:
(i) The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
(ii) The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]; and
(iii) The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv);
k. Documentation, at the time of performance, of packaging and labeling operations including:
1. 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 [21 CFR 111.260(k)(1)];
2. An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)]; and
3. 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)(3)];
l. Documentation, at the time of performance, that quality control personnel review any monitoring operations [21 CFR 111.260(l)(1)(i)];
m. Documentation, at the time of performance, of any required material review and disposition decision [21 CFR 111.260(m)];
n. Documentation, at the time of performance, of any reprocessing [21 CFR 111.260(n)]
We have reviewed your response letter dated October 5 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your response states that your “batch records have been updated and all process records required will be created and kept.” However, you did not provide supporting documentation with your response, such as a copy of an updated and completed BPR with your response.
5. Your firm failed to 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 have established no written quality specifications for your dietary supplement products. Once you have established product specifications for each dietary supplement that you manufacture, you must determine whether these specifications have been met, as required by 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records of such specifications, as required by 21 CFR 111.95(b)(1).
We have reviewed your response letter, dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your written response states that “hazard analysis and testing product specifications will be evaluated.” This response does not address the lack of specifications.
6. Your firm failed to identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement you manufactured and distributed, as required by 21 CFR 111.155(d)(1). Specifically, you do not have the capability to verify the shipping and production history of the herbal supplements produced at your firm. In addition, once you have established the required unique identifier, you must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of components that you receive and any lot of components that you produce, as required by 21 CFR 111.155(d)(2).
We have reviewed your response letter, dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your written response states that “component lot numbers have been added” to your batch sheets and that a “Lot Code Traceability Process will be established for all products manufactured at the facility.” However, you did not provide supporting documentation such as a BPR and a copy of the written procedures for component lot traceability with your response.
7. Your firm failed to 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). Specifically, you do not collect and hold reserve samples for each lot of packaged and labeled dietary supplements that you distribute. Reserve samples must be maintained in accordance with certain criteria, as specified in 21 CFR 111.83(b).
We have reviewed your response letter dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your written response indicated that you would establish a “hold process” and recordkeeping for all dietary supplements manufactured at the facility. However, you did not provide supporting documentation with your response.
8. Your firm failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils, including written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(c). Specifically, you have not established or implemented cleaning procedures for any of the equipment and utensils you use in manufacturing your dietary supplements. Once you have established the required sanitizing procedure you must implement it by maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d), and you must make and keep sanitization records as required by 21 CFR 111.35(a).
We have reviewed your response letter dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your written response states that “Sanitation Standard Operating Procedures (SSOPs) will be written and records maintained.” However, you did not provide supporting documentation with your response.
9. Your firm 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, you failed to perform and record calibration activities on equipment used in manufacturing, such as the (b)(4) of dietary supplements.
We have reviewed your response letter dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your written response states that you have been maintaining calibration records for your pH meters and indicated that a calibration process will be established and records will be maintained for all equipment. However, you did not provide supporting documentation with your response.
10. Your firm failed to establish and follow written procedures for fulfilling the requirements for the components, packaging, and labels, as required by 21 CFR 111.153. Specifically, you have not developed written procedures for receiving components, packaging, and labeling. In establishing the required written procedures, note that under 21 CFR 111.180(b)(2), the written procedures you must establish and follow include receiving records for components, packaging, and labels.
We have reviewed your response letter dated October 5, 2017; however, your response fails to demonstrate the sufficiency of your corrective actions. Your response states, “Documentation and Record Keeping Process will be maintained for Production and Process Control.” However, you did not provide supporting documentation with your response.
Adulterated Conventional Foods - Unapproved Food Additives
Any substance added to a conventional food must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)].
Your Yoder’s Good Health Recipe product contains substances that are food additives as defined in section 201(s) of the Act [21 U.S.C. 321(s)]. These substances include, but are not limited to, the following: Goldenseal and Black Cohosh. There is no food additive regulation which authorizes the use of Goldenseal or Black Cohosh. We are not aware of any information to indicate these substances are the subject of a prior sanction [see 21 CFR 181]. As explained below, we are not aware of any basis to conclude that these substances are GRAS for use in conventional foods.
FDA’s regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the view of qualified experts. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that the substance is not harmful under the conditions of its intended use as outlined in 107.3(i).
- Under 21 CFR 170.3(h), “[s]cientific procedures include the application of scientific data (including, as appropriate, data from human, animal, analytical, and other scientific studies), information, and methods, whether published or unpublished, as well as the application of scientific principles, appropriate to establish the safety of a substance under the conditions of its intended use.”
- Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive.” Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished scientific data, information, or methods.
- Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.” Under 21 CFR 170.30(c)(1), “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information.” Importantly, however, the fact that a substance was added to food before 1958 does not, in itself, demonstrate that such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
- Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and, (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).
We know of no basis for general recognition of safety for Goldenseal or Black Cohosh based either on scientific procedures or common use in food prior to January 1, 1958. In assessing the GRAS status of these substances for use in conventional foods such as yours, we considered the criteria described above. FDA is not aware of data to establish the general recognition of safety of these substances for use as an ingredient in conventional foods. Therefore, the use of these substances in your Yoder’s Good Health Recipe, would not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is also not aware of any other exemption from the food additive definition that would apply to Goldenseal or Black Cohosh for use as ingredients in a conventional food. Therefore, these substances added to a conventional food are food additives under section 201(s) of the Act [21 U.S.C. § 321(s)] and are subject to the provisions of section 409 of the Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Goldenseal or Black Cohosh are not approved for use in any conventional food. Consequently, your Yoder’s Good Health Recipe product which contains Goldenseal and Black Cohosh are adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)].
Misbranded Dietary Supplements
Based on labeling collected during the inspection of your firm, we note that several of your products are misbranded under section 403 of the Act and FDA’s labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101), as follows:
- Your Yoder’s brand Respiratory & Cough Formula, Stress & Anxiety Support, Life Drops, and Muscadine Grape Seed & Skin Extract are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the product labels fail to identify the product by using the term “dietary supplement” in accordance with section 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 the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or an appropriate descriptive term.
- Your Yoder’s brand Respiratory & Cough Formula, Stress & Anxiety Support, Life Drops, and Muscadine Grape Seed & Skin Extract products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343 (q)(1)(A)], because the serving size declared on the labels is incorrect. The serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in section 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example, the Yoder’s brand Respiratory & Cough Formula product label recommended use suggests the consumer takes “1/4 to ½ Teaspoon 1-3 times a day or up to 6 times a day as needed”, but the serving size lists “¼ tsp”. Further, the serving size must include the equivalent metric quantity in parentheses. An inaccurate serving size could cause a consumer to overconsume the product.
- Your Yoder’s brand Respiratory & Cough Formula, Stress & Anxiety Support, Life Drops, and Muscadine Grape Seed & Skin Extract products are misbranded within the meaning of section 403(q)(5)(F) of the Act [U.S.C. § 343(q)(5)(F)] in that the labels do not comply with section 21 CFR 101.36. Specifically, your product labels fail to list the quantitative amount per serving of each dietary ingredient contained in the product(s) in accordance with section 403(q)(5)(F)(ii) of the Act [21 U.S.C. § 343(q)(5)(F)(ii)] and 21 CFR 101.36(b)(3).
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations.
You should take prompt action to correct all 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 correct these violations, or prevent similar ones, may result in FDA taking legal action, including, without limitation, seizure or injunction.
In addition, we note the following:
- The Yoder’s Stress & Anxiety Support product has directions for use that informs the consumer that the product can be “placed under the tongue for 5 seconds for faster absorption.” You market this product as a dietary supplement. However, the Act defines the term “dietary supplement,” in part, as a product that is intended for ingestion.” [See section 201(ff)(2)(A)(i) of the Act (21 U.S.C. § 321(ff)(2)(A)(i))]. Though your product’s labeling provides instructions for ingestion, it also provides instructions for absorption into the body through the mucosal tissues. Products intended to enter the body directly through the mucosal tissues do not meet the definition of a dietary supplement.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such corrective actions. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
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 after 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.
