Editor's Note
On June 20, 2019, FDA issued this warning letter to HealthTech International, alleging multiple cGMP and labeling violations observed during a November 2018 inspection of the company's manufacturing facility. The company responded to FDA inspector observations, outlining several corrective actions, but FDA says it is unable to evaluate the adequacy of some of these corrective actions because of insufficient documentation. Among other points, t he warning letter reminds the company it must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless the company petitions FDA and the Agency exempts the company from the testing requirements.
June 20, 2019
Food and Drug Administration

From November 14-16, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1198 W 1130 N, St. George, Arizona. Based on the inspectional findings and a review of the product labels collected during the inspection,  we  have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at  www.fda.gov .
      
Dietary Supplement CGMP Violations
 
The dietary supplement products manufactured at your facility 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 prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). 
 
During the inspection of your facility, our investigator observed the following significant violations of CGMP requirements:
  1. Your firm’s quality control operations for the master manufacturing record and the batch product records failed to include reviewing and approving all master manufacturing records and all modifications to the master manufacturing records, as well as reviewing and approving all batch production-related records and reviewing all monitoring required under 21 CFR 111, Subpart E, as required by 21 CFR 111.123(a)(1)-(3).
We have reviewed your response dated November 27, 2018. In your response you state your intent to approve Master Manufacturing Records (MMRs), Batch Production Records (BPRs), and collect representative samples of all required samples. However, you did not provide documentation to support this; therefore, we are unable to evaluate the adequacy of your corrective actions.
  1. You failed to establish component specifications necessary to ensure that specifications for dietary supplements are met. Specifically, you failed to establish the following component specifications for each component that you use in the manufacture of a dietary supplement:
  2. Identity specification [21 CFR 111.70(b)(1)]
  3. Component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]
  4. Specifications that establish the 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 [21 CFR 111.70(b)(3)]
We note that once you have established these specifications, you must determine whether the specifications that you establish under 21 CFR 111.70 are met, as required by 21 CFR 111.73 and 21 CFR 111.75. For example, once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components, as required by 21 CFR 111.75(a)(2).
 
We have reviewed your response dated November 27, 2018 in which you state your intent to establish specifications for components and finished product, and state you have changed the label for the (b)(4) product to remove Magnesium, Silica, Selenium, and Zinc. However, we are unable to evaluate the adequacy of your corrective actions, because you did not provide evidence of the revised label or established specifications.
  1. You failed to establish product specifications for the identity, purity, strength, composition of the finished 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, during the inspection our investigator observed that you did not have finished product specifications for the (b)(4) that you contract manufacture.
Further, once these product specifications for the finished batch of dietary supplements have been established, you must determine whether they are met in accordance with 21 CFR 111.75(c), and you must make and keep records of such specifications in accordance with 21 CFR 111.95(b)(1). During the inspection, you provided our investigator with a copy of the Certificate of Analysis with results for specific gravity, microbiology and heavy metals for (b)(4) dietary supplements you contract manufacture; however, you were unable to provide established finished product specifications when requested by our investigator for these dietary supplement products.
 
We have reviewed your response dated November 27, 2018 in which you state your intent to establish specifications for purity, strength and composition of the finished products. Your response also states you currently test every batch for microbial analysis and heavy metals. As previously stated, you must first establish specifications for the identity, purity, strength and composition of the finished dietary supplement and then verify the finished product meets these specifications. We are unable to evaluate the adequacy of your corrective actions, because you did not provide documentation of the specifications.
  1. Your master manufacturing records (MMRs) for the (b)(4) products failed to include the following information as required by 21 CFR 111.210:
  2. 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)]
  3. A statement of the theoretical yield of a manufactured dietary supplement at each point, step, or stage of the manufacturing process to ensure quality control, the expected yield of the finished dietary supplement, including maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]
  4. A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]
We have reviewed your response dated November 27, 2018 in which you state your intent to include the identity and weight of the dietary ingredients, theoretical yield, and description of the label on the Master Manufacturing Records. However, we are unable to evaluate the adequacy of your corrective actions, because you did not provide documentation of the revised MMRs.
  1. Your firm’s batch production record (BPR) did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. For example, your batch production records for (b)(4) (lots(b)(4) and (b)(4)), (b)(4) (lots (b)(4) and (b)(4)), and (b)(4) (lots (b)(4) and (b)(4)) did not include the following:
  2. The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)]
  3. 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 longs, where this information is retained [21 CFR 111.260(c)]
  4. The unique identifier that you assigned to each component, packaging and label [21 CFR 111.260(d)]
  5. A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]
  6. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)]
  7. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)]
  8. Documentation, at the time of performance, of packaging and labeling operations, including an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. [21 CFR 111.260(k)(2)]
  9. Documentation, at the time of performance, of packaging and labeling operations, including the results of any tests or examinations conducted on packaged and labeled dietary supplements or a cross-reference to the physical location of such results. [21 CFR 111.260(k)(3)]
  10. Documentation, at the time of performance, that quality control personnel reviewed the batch production record, including any monitoring operation required under 21 CFR 111, Subpart E and the results of any tests or examinations on the finished batches of dietary supplements. [21 CFR 111.260(l)(1)]
  11. Documentation, at the time of performance, that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement. [21 CFR 111.260(l)(4)]
We have reviewed your response dated November 27, 2018 in which you state your intent to modify your batch production records to include all the information related to the production and control of each batch. However, we are unable to evaluate the adequacy of your corrective actions, because you did not provide documentation of revised batch records.
  1. You have not established specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications) as required by 21 CFR 111.70(d).
  2. You did not establish and follow written procedures for fulfilling the requirement for equipment and utensils, as required by 21 CFR 111.25. Specifically, you failed to have written procedures for:
a. Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a).
b. 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).
 
We have reviewed your response dated November 27, 2018 in which you state your intent to keep documentation of the use, maintenance, cleaning and sanitizing of equipment. However, we are unable to evaluate the adequacy of your corrective actions, because you did not provide evidence of the corrective actions, which should include a written procedure. Once you have established the written procedures, you are required to make and keep records in accordance with 21 CFR 111.35.
  1. You do not 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 that you manufactured and distributed as required by 21 CFR 111.155(d). Specifically, you do not use unique identifiers for components that you receive.  

Misbranded Dietary Supplements
 
The dietary supplement products discussed below are misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act and/or fail to comply with the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.
 
During the inspection, you explained to our investigator that you are responsible for the content of the Supplement Facts label only on the products contract manufactured by your firm. To the extent that your firm labels products on behalf of another firm that releases for distribution that product under their firm’s name, your firm nevertheless has an obligation to know whether that product’s label and labeling is in conformance with the Act (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). The Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is misbranded under section 403 of the Act (see 21 U.S.C. 342(g) and 331(a)). 
  1. The (b)(4) products you manufacture are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label claims are false or misleading. Specifically, the (b)(4) labels claim “(b)(4) Nourishing Minerals” and “(b)(4) trace minerals” but does not list at least (b)(4) minerals in the Supplement Facts label or ingredient statement.
 
  1. The (b)(4) product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. The (b)(4) label states, “(b)(4)….” Health Tech International’s website  http://www.healthtechint.com/elements_in_microbiotics.htmExternal Link Disclaimer
  2.  states “the Microbiotic complex is formed within living cells (microbes) during their life function. The complexes they form were previous ingredients of living cells (mostly plant matter).” The “Microbiotic Complex” is not made from a plant, but is from the action of soil bacteria acting upon decomposed plant material.
 
  1. The (b)(4) products are misbranded within the meaning of section 403(s)(2)(B) of the Act [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).
 
  1. The (b)(4) product you manufacture is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4(h). Specifically, the product lists “(b)(4)” as an “Other Ingredient” on the label. This “Complex” has multiple sub-ingredients and the label does not include those sub-ingredients. The (b)(4) product you manufacture is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that the product label declares the names Vitamin B2, B5, and B9, which are not the common or usual names of dietary ingredients. Furthermore, Vitamin D3 should be listed as Vitamin D, with the source ingredient, cholecalciferol being declared as required by 21 CFR 101.36(d) and 21 CFR 101.4(g). The (b)(4) product fails to declare an ingredient list that includes the guava, holy basil, and lemon extracts.
 
  1. The (b)(4) products are misbranded within the meaning of section 403(s)(2)(A) and 403(q)(5)(F) of the FD&C Act [21 U.S.C. §343(s)(2)(A) and 343(q)(5)(F)] in that the label fails to list the name of each dietary ingredient (and source as required) of the supplement that is described in section 201(ff) and the quantity of each such dietary ingredient per serving with the appropriate %DV. For example:
  2. The (b)(4) product labels include statements, such as “plant-based (b)(4),” and “plant-based (b)(4).” However, specific plants relating to these terms are not identified in the label of these products. [21 CFR 101.36(b)(3)].
  3. The (b)(4) products list a Proprietary Blend but do not include the quantity of the Blend. [21 CFR 101.36(b)(3)(ii)].
  4. The (b)(4) products Supplement Facts label lists “Proprietary Blend,” and “Celectrolyte,” but does not list the ingredients of each named term inside the Supplement Facts label. Specifically,
  5. The (b)(4) lists a “Mineral Complex” and a “Proprietary Blend” inside the Supplement Facts label. The ingredients of the Blend are linked by use of a symbol to a “Mineral Complex” partial list of ingredients located outside of the Facts label. The use of a symbol for this purpose is not provided for in 21 CFR 101.36(b)(3). It is unclear if the “Mineral Complex” and the “Proprietary Blend” in the Facts label are intended to refer to the same ingredients.
  6. The (b)(4) lists “Celectrolyte Complex” in the Supplement Facts label but not the ingredients comprising this Complex. Outside of the Supplement Facts label, we note “Microbiotic Complex” followed with a partial list of mineral/element names. It is unclear if these two are intended to refer to the same Complex. Furthermore, the list of element names is not a list of ingredients, but rather a list of mineral/elements that occur naturally in certain soils.
  7. The (b)(4) product Supplement Facts label lists “Proprietary Blend” with a symbol to the “(b)(4)complex”, which is located outside of the Facts label. The use of a symbol for this purpose is not provided for in 21 CFR 101.36(b)(3).
  8. The (b)(4):
  9. declares 275% Daily Value (DV) for Vitamin B1. We note the amount should be 267% DV, if one uses the RDIs that existed prior to the May 2016 Nutrition Facts and Supplement Facts Label and Serving Size final rules.
  10. incorrectly declares chromium with a % Daily Value of 1%. Chromium, a (b)(2)‐dietary ingredient, may only be declared, if at a significant %DV (2% or more), in accordance with 21 CFR 101.36(b)(2).
  11. incorrectly lists the unit of measure for folic acid (“Vitamin B9”) as milligrams. The correct unit of measure is micrograms.
  12. incorrectly lists Vitamin B1 and Vitamin B2. The correct listing should be Thiamin (Vitamin B1) and Riboflavin (Vitamin B2) in accordance with 21 CFR 101.9(c)(8)(v).
  13. The (b)(4)
  14. declares the nutrients iron, iodine, chromium, and molybdenum with a percent Daily Value that is not consistent with the Daily Value obtained by either utilizing the revised RDIs noted in the May 2016 Nutrition Facts and Supplement Facts Label and Serving Size final rules or the previous RDIs prior to the final rule.
  15. fails to present the percent of Daily Value in separate columns for each intended group of persons as noted in the label directions, per 21 CFR 101.36(b)(2)(E).
  16. The (b)(4) declares the source of certain dietary ingredients, such as (b)(4), etc. as “plant” which is not a common or usual name.
  17. The (b)(4) products each declare fulvic acid as a dietary ingredient on the Supplement Facts label. Furthermore, the source of the fulvic acid fails to be declared either in the Supplement Facts label or an ingredient list.
  18. The (b)(4) product label states that the product has a concentration of (b)(4) parts per million ionic silver. Based upon the serving size and the ionic silver concentration, the (b)(4) mg amount of ionic silver per serving is incorrect.
 
  1. Your (b)(4) product is 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 label is incorrect. Serving size for a dietary supplement is the maximum amount consumed 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. The product label lists the serving size as one (1) ounce; however, the directions state to take “½ ounce (1 tablespoon or ½ capful) per adult, morning and evening” and ½ of an adult serving for children.
 
  1. We have determined the (b)(4) and (b)(4) products are adulterated under Section 402(a)(2)(C)(i) of the Act [21 USC 342(a)(2)(C)(i)] because they bear or contain an unsafe food additive. Specifically, your products contain Stevia and Stevia leaf extract, respectively, which are unapproved food additives under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. 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 the Act and implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction or prosecution.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct the violations, including an explanation of how your firm plans to prevent these violations from occurring again and copies of related documentation. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
 
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 re-inspection related costs. A re-inspection 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. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.