- Delivery Method:
- VIA UPS
Recipient NameSteven D. Roderick
- Global Vitality, Inc. dba Enzyme Process International
470 N. 56th Street
Chandler, AZ 85226
- Issuing Office:
- Division of Human and Animal Food Operations West IV
April 16, 2020
AMENDED WARNING LETTER
Ref: # DEN-20-02-WL
Dear Mr. Roderick:
From April 15-24, 2019, the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 470 N. 56th Street, Chandler, Arizona. Based on the inspectional findings, a review of the product labels collected during the inspection, and a review of your website at www.enzymeprocess.co, 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.
Unapproved New Drugs/Misbranded Drugs
FDA reviewed your website at www.enzymeprocess.co in September 2019 and has determined that you take orders there for the following products: Liverchol, Celery Seed, ColoNorm G, Agaricus Blazei Mycelia, Zymepro, B-Plus w/Glandulars, Thyroid Cytotrophin, and Alkaplex Green 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.
Examples of some of the claims observed on your website that provide evidence that these products are intended for use as drugs include the following:
LiverChol, product page
- “The herbs in Liverchol . . . lower LDL cholesterol . . . [and] help the liver to defend itself against certain viral infections. . . . The herbs in Liverchol along with a balanced diet may help prevent Non-Alcoholic Fatty Liver Disease.”
ColoNorm G, product page
- “The herbs, bentonite and magnesium ascorbate may reduce the transit time through the intestinal tract. Reducing the transit time through the intestinal tract may lessen the risk for inflammatory diseases of the colon.”
- “May Reduce Inflammation.”
ZymePro, all sizes, including Veggie, product pages
- “During inflammation flare ups, take 3 tablets twice daily.”
B-Plus w/Glandulars, product page
- “Fight Chronic Fatigue with our Superior B-Complex Formulation”
Agaricus Blazei Mycelia, from blog of December 10, 2018, entitled: “Agaricus Blazei Mycelia”
- “The Japanese use an Agaricus water/ethanol extract to treat arteriosclerosis, hepatitis, high cholesterol, diabetes, dermatitis, and cancer. Japanese research shows that compounds called polysaccharides and anti-angiogenic compounds present in Agaricus may be responsible for its antitumor properties. . . . Additional beneficial effects of Agaricus water/ethanol extracts found in studies include an increase in insulin sensitivity in diabetics. . . . [This increase in insulin sensitivity] may also improve serum glucose and cholesterol levels.”
Thyroid Cytotrophin, from blog of March 21, 2019, entitled: “What Is a Protomorphogen?”
- “Data taken from a database of over a thousand subjects has shown the beneficial effect of liver, thyroid and lung glandular concentrates on their respective target tissues by moving their serum chemistries generally up toward the ideal range and those which were above the medical range, move down, toward the ideal range, when an individual ingests the appropriate thyroid treatment or protomorphogen.”
Celery Seed, from blog of December 12, 2018, entitled: “Celery Seed – Improve digestion and liver functions and stimulates the kidneys to promote urine flow.”
- “The modern use of celery focuses on its anti-inflammatory and anti-arthritic properties for joint pain and gout.”
- “Celery seed along with an anti-gout diet may help to reduce gout flares.”
- “Celery seed has anti-microbial activity specifically against Helicobacter pylori (H. Pylori) . . . For people with a history of Helicobacter pylori induced ulcers, regular use of celery seed may be helpful.”
Alkaplex Green, from blog of December 10, 2018, entitled: “ALKAPLEX GREEN “Salad in a capsule.”
- “Barley Greens [an ingredient in Alkaplex Green] contain antioxidants that stop free radicals and reduce inflammation. Inflammation is the first step in many diseases including arthritis and cancer. Reducing inflammation helps to prevent many diseases.”
- “Wheat Grass [an ingredient in Alkaplex Green] . . . contains bioflavonoids such as apigenin. . . . The bioflavonoid apigenin is a potent anti-inflammatory.”
- “Alfalfa [an ingredient in Alkaplex Green]. . . is effective against diabetes, thyroid gland malfunction, arthritis, high cholesterol, and peptic ulcers.”
- “Chlorophyll [an ingredient in Alkaplex Green] is able to form tight molecular complexes with certain chemicals known or suspected to cause cancer. The protective mechanism of chlorophyll is quite simply – it just binds with and sequesters carcinogens within the gastrointestinal tract until they pass out of the body.”
- “Spirulina [an ingredient in Alkaplex Green] benefits the cardiovascular system by lowering bad cholesterol . . . and has anti-inflammatory activity.”
- Parsley Leaf [an ingredient in Alkaplex Green] . . . may prevent diabetes, has mild pain relieving properties, prevents ulcers, lowers blood pressure and is anti-bacterial and anti-fungal. Parsley may prevent urinary tract infections.”
- “Celery [an ingredient in Alkaplex Green] contains . . .anti-inflammatory properties. Celery may help lower blood pressure and cholesterol. . . . Celery reduces factors that cause cancer.”
- “Watercress [an ingredient in Alkaplex Green] reduces DNA damage which is linked to a reduced risk of cancer. The reduced risk of cancer is by increasing carotenoid concentrations (antioxidants) in the body.”
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 USC § 321(p)(1)]. 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 USC §§ 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 Liverchol, Celery Seed, Agaricus Blazei Mycelia, B-Plus w/Glandulars, Thyroid Cytotrophin, and Alkaplex Green products are intended for 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 these products safely for their intended purposes. Accordingly, your Liverchol, Celery Seed, Agaricus Blazei Mycelia, B-Plus w/Glandulars, Thyroid Cytotrophin, and Alkaplex Green products 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)].
Dietary Supplement CGMP Violations
The dietary supplement products that you manufacture, package, label, and/or hold 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 in 21 CFR Part 111. Additionally, even if the product labeling for your Alkaplex Green did not have therapeutic claims which make this product an unapproved new drug and misbranded drug, this product would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act because the product has been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Following the April 2019 inspection of your facility, FDA issued a Form FDA 483 Inspectional Observations addressing many of the issues discussed below. We have received two written responses from you dated May 14 and August 9, 2019, which will be addressed as appropriate below.
The significant violations documented during the inspection include, but are not limited to, the following:
1. Your quality control personnel failed to comply with 21 CFR 111.123(b)(1) because they approved and released for distribution a batch of dietary supplement for which a component in the batch did not meet its identity specification. Specifically, your quality control personnel approved and released for distribution Advance CardioZyme Capsules Lot #5237 and Pro-T-Complex Capsules Lot #4897 that were manufactured with the components Phosphatidyl Choline (Lot# (b)(4)) and Zinc (b)(4) (Lot# (b)(4)), respectively; neither component met its established identity specification.
We have reviewed your written response, dated May 14 and August 9, 2019, which purport to address this deficiency either by establishing new identity specifications or retesting the components at issue to confirm compliance. Such activities do not demonstrate that you have taken corrective action to ensure that you will comply with applicable quality control requirements going forward.
2. You failed to ensure that the test and examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, you used (b)(4) to verify the identity of (b)(4) Thyroid Substance Lot# (b)(4), which is an ingredient in your product Thyroid HP; however, (b)(4) lacks the specificity to identify the ingredients in multi-ingredient dietary supplement products or distinguish between products with similar chemical structures, such as (b)(4) substance (b)(4), thymus substance (b)(4), and hypothalamus substance (b)(4).
3. You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel, for use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d). For example, it was observed that you tested Manganese (b)(4) Chelate Lot# (b)(4) (a dietary ingredient in your Pro-T-Complex product) by (b)(4) using Zinc (b)(4) Chelate Lot# (b)(4) as the standard spectrum. Zinc (b)(4) Chelate is not an appropriate standard spectrum for Manganese (b)(4) Chelate.
We have reviewed your written response, dated May 14, 2019. In your response, you state that you tested Manganese (b)(4) Chelate Lot# (b)(4). Lot# (b)(4) is not the lot observed at the time of the inspection (Lot# (b)(4)). Also note that comparison of the sample of Manganese (b)(4) Chelate with (b)(4) of material does not constitute comparison with standard reference materials. You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods (see 21 CFR 111.75(h)(1)).
4. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition for each component that you use in the manufacture of a dietary supplement are met, as required by 21 CFR 111.70(b)(2). For example, you have not established specifications for purity, strength, and composition of your Irish Moss (b)(4) used in the manufacture of your Pro-T-Complex dietary supplement capsules, or your (b)(4) used in the manufacture of your Advance CardioZyme.
We have reviewed your written response regarding this issue, dated May 14, 2019. In your response, you provided the specifications for several components used in the manufacture of your products. However, none of the component specifications include all of the specifications required by 21 CFR 111.70(b)(2). For example, the provided specifications for the Irish Moss (b)(4) does not include specifications for purity, strength, or composition.
5. You failed to establish product specifications for the identity, purity, strength and composition of the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you failed to establish:
- Identity and purity specifications for your CardioZyme and Pro-T-Complex dietary supplements.
- Strength specifications (i.e., assay) for the Irish Moss and Glandular Blend ingredients in your Pro-T-Complex and the EDTA, Guggul, Phosphalidyl Choline, Nattokinase, and Policosanol ingredients in your CardioZyme.
- Composition specifications for your Advanced CardioZyme and Pro-T-Complex products. During the inspection you provided purported specifications for your Pro-T-Complex product, but the documentation you provided fails to account for the Irish Moss and Glandular Blend ingredients in the product. You were unable to provide any composition specification for the Advanced CardioZyme.
We have reviewed your written response regarding this issue, dated May 14, 2019. In your response, you provided Finished Product Specification Sheets for Advance CardioZyme Capsules (Version 01) and PRO-T-Complex Capsules (Version 01). However, we identified the following problems with your specification sheets:
- The finished product specifications for Advance CardioZyme Capsules and PRO-T-Complex Capsules do not include established identity specifications.
- Your assay specification for Advance CardioZyme states all ingredients must be (b)(4) to (b)(4)% of label claim; however, it does not include the composition and strength of each dietary ingredient that will be claimed on the product label. Additionally, your finished product label for CardioZyme states the product contains 50% Octacosanol; therefore, you need to establish a purity specification to verify that NLT 50% Octacosanol is present in the product.
- Your assay specification for PRO-T Complex states it contains a proprietary blend of (b)(4); however, it does not include the composition and strength of the ingredients that comprise the proprietary blend. Additionally, verification of your proprietary blend is by (b)(4). Verification that a specification has been met is determined by testing and not by (b)(4).
6. You failed to establish master manufacturing records (MMR) for the Advance CardioZyme Caps and Pro-T-Complex Capsules that include all elements required by 21 CFR 111.210. Specifically, your MMRs for these products fail to include:
- A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the 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)]. For example, these MMRs lacked a statement of theoretical yield at the encapsulation and bottling stages of the manufacturing process.
- 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)]. For example, your MMR’s for Advance CardioZyme Caps and Pro-T-Complex Capsules provide an inconsistent description of your packaging materials. Both MMRs state that a “(b)(4)”; however, (b)(4) is not listed elsewhere in your MMR as a packaging material (i.e., in your Packaging Traveler Record).
- Written instructions for procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
We have reviewed your written response, dated May 14, 2019. In your response, you provided a revised MMR template for (b)(4) Capsules. The revised template includes a theoretical yield as required by 21 CFR 111.210(f). However, the revised template does not include a description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label as required by 21 CFR 111.210(g). It also does not include written instructions for procedures for sampling (21 CFR 111.210(h)(2)). It cross refences to an SOP, but you did not provide a copy of the SOP for review which may have allowed us to determine whether this requirement has been met.
7. Your batch production records (BPR) fail to meet the requirements of 21 CFR 111.255. Specifically, your BPR for Alkaplex Green, Lot #4263, failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) (see also 21 CFR 111.260). Specifically, during a previous FDA inspection that ended November 28, 2016, FDA observed certificates of analysis for this lot that demonstrated that your Alkaplex Green did not meet specifications established in accordance with 21 CFR 111.70(e) (see 21 CFR 111.260(i)). During the April 2019 inspection, however, the investigator found that you no longer have these original certificates of analysis. Therefore, the BPR for Lot #4263 of Alkaplex Green fails to include complete information relating to the production and control of each batch.
We have reviewed your written response, dated May 14, 2019. In your response, you provided copies of three Certificates of Analysis for Alkaplex Green, lot #4263. However, you did not provide the entire batch production record for review. As such, we are unable to evaluate the sufficiency of your corrective action.
8. You failed to use equipment or utensils of appropriate design, construction and workmanship to enable them to be adequately cleaned and properly maintained, as required by 21 CFR 111.27(a). Specifically, your (b)(4) equipment used for tableting your dietary supplement products was observed to contain (b)(4) on various product contact surfaces, which does not allow the equipment to be adequately cleaned and properly maintained. This is a repeat observation from the 2016 inspection.
We have reviewed your written response, dated May 14, 2019. In your response, you provided photos purporting to demonstrate the removal of the (b)(4). However, there is a (b)(4) on the tablet (b)(4) that is an obstruction to cleaning non-product contact surfaces. It appears a (b)(4) attached to a (b)(4) has (b)(4) to it in Room (b)(4) and what appears to be product residue on the tablet (b)(4).
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. Even if your Enzyme Process brand ZymePro Thyroid Cytotrophin, and B Plus with Glandulars products were not unapproved new drugs/misbranded drugs, they would be misbranded within the meaning of section 403 of the Act and/or in violation of the following provisions of 21 CFR Part 101.
1. Your Enzyme Process brand Multi Life product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. § 321(n))]. Specifically, the label for this product fails to bear the following warning statement about the risk of fatal poisoning in children under 6: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.” Dietary supplements in solid oral dosage form that contain iron or iron salts are required to bear this warning statement [see 21 CFR 101.17(e)]. The label on your Multi Life product, which is in capsule form, declares iron as an ingredient. However, the label does not include the warning statement required by 21 CFR 101.17(e).
2. Your Parathyroid Dietary Supplement Capsules are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular. Specifically, the product label states that the parathyroid source is porcine, but the BPR for lot (b)(4) shows that the source was (b)(4).
3. Your Enzyme Process brand Multi Life, Alkazyme 3, CoQ10, SuperGest, Uterus Cytotrophin, Lung Cytotrophin, Mammary Cytotrophin, Liver Cytotrophin, Heart Cytotrophin, Orchic Cytotrophin, Thymus Cytotrophin, Thyroid Cytotrophin, Ovary Cytotrophin, Pancreas Cytotrophin, Parathyroid, Pro-T-Complex, and Advanced CardioZyme products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:
a. Your Enzyme Process brand Multi-Life product lists “Citrus Bioflavanoids,” “72 Trace Mineral Blend” and “Phosphatidyl Serine Complex” which appear to be ingredients which themselves contain ingredients (sub-ingredients) but fail to list the sub-ingredients. Further, the label fails to list the capsule ingredients.
b. Your Enzyme Process brand Alkazyme 3 product fails to list the capsule or it’s ingredients.
c. Your Enzyme Process brand CoQ10 product fails to list the capsule ingredients; furthermore, “pharmaceutical CoQ10” is not the common or usual name of the dietary ingredient.
d. Your Enzyme Process brand SuperGest product lists “Gastric Mucosa Substance” which is not the common or usual name. Further, the label fails to list the capsule ingredients.
e. Your Enzyme Process brand Uterus Cytotrophin, Lung Cytotrophin, Mammary Cytotrophin, Liver Cytotrophin, Heart Cytotrophin, Orchic Cytotrophin, Thymus Cytotrophin, Thyroid Cytotrophin, and Ovary Cytotrophin products list glandulars and substances for each of the organs listed as USP. However, USP does not have listings for Uterus Cytotrophin, (b)(4), Lung Substance USP, (b)(4), Cytotrophin, Mammary Glandular, Liver Substance, Heart Substance, Orchic Glandular, Thymus Glandular, Thyroid Glandular, and Ovary Glandular. Therefore, these are not the common or usual names for the ingredient.
f. Your Enzyme Process brand Pancreas Cytotrophin product lists Pancreas Substance, Porcine as an ingredient. This is not the common or usual name for the ingredient.
g. Your Enzyme Process brand Parathyroid product lists Spleen Substance, Biovine [sic] as an ingredient. This is not the common or usual name for an ingredient. Further, the label fails to list the capsule ingredients.
h. Your Enzyme Process brand Pro-T-Complex and Advanced CardioZyme products fail to list the capsule ingredients.
4. Your Enzyme Process brand ZymePro, Enzyme Process brand Multi Life, Enzyme Process brand Alkazyme 3, and Enzyme Process brand Pancreas 523 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 are 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. For example:
a. The Suggested Use for your Enzyme Process brand ZymePro states to “take 3 tablets twice daily” during inflammation flare-ups but your serving size is listed as “2 tablets.”
b. The Suggested Use for your Enzyme Process brand Multi Life states to “take 1-2 capsules 3 times daily” but your serving size is listed as “3 capsules.”
c. The Suggested Use for your Enzyme Process brand Alkazyme 3 states “1 to 2 capsules with meals” but your serving size is listed as “1 Capsule.”
d. The Suggested Use for your Enzyme Process brand Pancreas 523 states “1 to 2 tablets with each metal [sic]” but your serving size is listed as “1 Tablet.”
5. Your Enzyme Process brand Alkazyme 3 product is misbranded within the meaning of section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes a mandatory disclaimer.
6. Your Enzyme Process brand Pancreas Cytotrophin, ZymePro, Alkazyme 3, CoQ10, B Plus with Glandulars, SuperGest, Pancreas 523, Pancreas Cytotrophin, Liver Cytotrophin, and Omega Complex products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the presentation of the nutrition information on the labels of the products do not comply with 21 CFR 101.36 and 21 CFR 101.9. For example:
a. Your Enzyme Process brand Pancreas Cytotrophin, ZymePro, Alkazyme 3, CoQ10, B Plus with Glandulars, SuperGest, Pancreas 523, Pancreas Cytotrophin, and Liver Cytotrophin products fail to appropriately position the required heavy bar(s) in the Supplement Facts label, per 21 CFR 101.36(e)(6). Heavy bars are required: beneath the subheading “Servings Per Container” except that if this subheading is not required and as a result not declared, it shall be placed beneath the subheading “Serving Size;” beneath the last dietary ingredient to be listed per 21 CFR 101.36(b)(2)(i); and, beneath the last other dietary ingredient to be listed per 21 CFR 101.36(b)(3).
b. Your Enzyme Process brand B Plus with Glandulars product label lists the names of Vit B3 and Vit B5. Your Enzyme Process brand Multi-Life product label lists Betatene®, niacinamide, and Vit D-3 (natural). Each of these dietary ingredients or source of a dietary ingredient is not the common or usual name of the dietary ingredient or a source ingredient, per 21 CFR 101.9(c)(8)(iv) and (v) and 21 CFR 101.4.
c. Your Enzyme Process brand Omega Complex product lists EPA and DHA in the Supplement Facts label. These names are not the common or usual names of the dietary ingredients, per 21 CFR 101.36(b)(3) and 21 CFR 101.4.
The violations cited in this letter are not intended to be an all-inclusive list 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 or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure and injunction.
We also offer the following comments:
- Relating to your responsibilities to follow CGMPs for dietary supplements, for the Pro-T Complex, you list (b)(4) assay tests to be performed on the (b)(4) lots and then (b)(4) thereafter. In order for you to conduct (b)(4) lot testing of the finished dietary supplement, you must provide adequate documentation to support your basis for not testing every finished product batch; the quantity of batches and frequency for testing must be supported by a sound statistical sampling plan; and your quality control personnel must review and approve this practice (see 21 CFR 111.75(c)).
- Your Enzyme Process brand B-12 Advanced product is labeled as a dietary supplement. However, the suggested use for the product states, “Allow tablets to disolver [sic] under tongue.” Only products that are intended for ingestion may be lawfully marketed as dietary supplements under section 201(ff) of the Act.
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 the corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections. If you do not believe that your products are 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 means 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection related costs from the responsible party for the domestic facility.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathy Tormey, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at Kathleen.email@example.com or (303) 236-3137 if you have any questions about this matter.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods –
Division IV West