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This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 2810 Hopi Drive, Sedona, Arizona from July 11, 2022, through July 15, 2022. The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. You can find the Act and the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
We received your response on August 4, 2022, which was written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We address your response below.
Unapproved New Drugs and Misbranded Drugs
During the inspection, our investigator collected finished product labels for your products and the Herbal Vitality product catalog in which you offer your products for sale. Based on our review of your product labels and product catalog, we have determined that the claims for your products Acute Kidney Stone Relief, Adult Cold & Flu, Antifungal Formula, Baby Cold & Flu, Children’s Antibiotic Formula, Children’s Asthma Formula, Hemorrhoid Remedial, Pregnancy Cold and Flu Formula, Prostrate Formula, Special Lyme Formula, Fibromyalgia Formula, Hepatitis C Formula Glycerite, Kidney Stone Remedial, Lung Tonic COPD, Children’s Antiviral Formula, Children’s Allergy Relief Formula, Antiparasite Formula, Anti-Amoeba Formula, Hyperthyroid Relief, PCOS Formula, and Children’s Tonsillitis/Otitis establish 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:
Acute Kidney Stone Relief
• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent kidney stones.
• Product catalog: “…antispasmodic analgesic and demulcent, and aid in relief of renal and ureter spasm and inflammation.”
Adult Cold & Flu
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent cold and flu.
• Product catalog: “The herbs in this formula are antimicrobial, alterative, analgesic and diaphoretic.”
Antifungal Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent fungal infections.
• Product catalog: “The antifungal herbs assist the body in ridding fungal overgrowth in order to restore healthy flora balance.”
Baby Cold & Flu
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent cold and flu.
• Product catalog: “…the herbs bring their actions to respiratory and digestive tracts and help clear a fever. Anti-viral, diaphoretic, expectorant, antispasmodic, carminative…”
Children’s Antibiotic Formula
• Product name: The product name implies the product is intended to cure, mitigate, or treat bacterial infections.
• Product catalog: “…broad antimicrobial effects along with lymphagogue actions that cleanse the tissues and strengthen immunity. Diaphoretic herbs assist with fever management.”
Children’s Asthma Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent asthma.
• Product catalog: “The herbs in this formula are antispasmodic bronchodilators. They are anti-inflammatory, expectorant, antimicrobial, demulcent…”
Hemorrhoid Remedial
• Product name: The product name implies the product is intended to cure, mitigate, or treat hemorrhoids.
Pregnancy Cold and Flu Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent cold and flu.
• Product catalog: “The herbs in this formula are…antiviral, expectorant, antispasmodic, alterative, carminative…”
Prostrate Formula
• Product catalog:
- Formula heading: “Adjunctives to cancer treatment”
- “The herbs [in this formula]…have anti-tumor properties.”
Special Lyme Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent Lyme disease.
• Product catalog: “A blend of herbs with antimicrobial, anti-inflammatory…actions…”
Fibromyalgia Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent fibromyalgia.
Hepatitis C Formula Glycerite
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent Hepatitis C.
Kidney Stone Remedial
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent kidney stones.
Lung Tonic COPD
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent chronic obstructive pulmonary disease (COPD).
Children’s Antiviral Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent viruses.
Children’s Allergy Relief Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent allergies.
Antiparasite Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent parasites.
Anti-Amoeba Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat or prevent amoeba infection.
Hyperthyroid Relief
• Product name: The product name implies the product is intended to cure, mitigate, or treat hyperthyroidism.
PCOS Formula
• Product name: The product name implies the product is intended to cure, mitigate, treat, or prevent polycystic ovary syndrome (PCOS).
Children’s Tonsillitis/Otitis
• Product name: The product name implies the product is intended to cure, mitigate, treat or prevent tonsillitis/otitis.1
• Product catalog: “Antimicrobial and lymphagogue herbs are combined with alternative, anodynal, and diaphoretic herbs to tonify mucous membranes and immune system, cleanse the tissues and clear heat.”
Your above 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 Special Lyme Formula, Hepatitis C Formula Glycerite, Kidney Stone Remedial, Lung Tonic COPD, Acute Kidney Stone Relief, Adult Cold & Flu, Baby Cold & Flu, Children’s Asthma Formula, Pregnancy Cold and Flu Formula, and Fibromyalgia Formula 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 your products safely for its intended purposes. Accordingly, your products fail to bear adequate directions for its intended use and, therefore, your 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
During the inspection, our investigator found significant violations of FDA’s regulation 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). Based on the inspection, we determined that these violations cause the dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Additionally, even if your Children’s Tonsillitis/Otitis product were not an unapproved new drug, it would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)].
Your significant violations of the CGMP requirements are as follows:
1. You failed to establish, for each component that you use in the manufacture of a dietary supplement, component specifications on limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3). Specifically, you have not established limits on contaminants such as microbes, pesticides, and heavy metals that may be present in your components, including the Eleutherococcus senticosus, Astragalus membranaceus, and Ganoderma lucidum used in your Immune Tonic (Lot 052422); and the Calendula officinalis, Echinacea angustifolia, and Filipendula ulmaria used in your Children’s Tonsillitis/Otitis (Lot 031722).
Note that in addition to establishing specifications, you must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
We have reviewed your written response, in which you state, “Specifications for limits on contamination will be added to all current and new Master Manufacturing Records for multi-dietary ingredient herbal tincture and glycerite supplements when contamination is a possibility.” We cannot evaluate the adequacy of your corrective action because you did not provide any specifications for limits on contamination for review.
2. You failed to establish 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, your firm has not established product specifications for any of your multi-ingredient finished dietary supplement products.
Note that in addition to establishing specifications, you must verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and limits on contamination that may adulterate or lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). Further, you must ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of all activities relating to such specifications, in accordance with 21 CFR 111.95.
We have reviewed your written response, in which you state, “We have begun to update or create Master Manufacturing Records for all our multi-dietary ingredient herbal tincture and glycerite supplements, to include specifications for identity, strength, and composition of the finished dietary supplement.” Your response also states, “Specifications for limits on contamination will be added to all current and new Master Manufacturing Records for multi-dietary ingredient herbal tincture and glycerite supplements when contamination is a possibility.” However, we cannot evaluate the adequacy of your corrective actions because the updated master manufacturing record for your Children’s Tonsils & Ear Formula, included with your response, does not include finished product specifications for identity, purity, strength, composition, and limits on contaminants; in addition, you have not provided specifications for your other dietary supplement products.
3. You failed to include in your quality control operations in your master manufacturing record, batch production record (BPR), and manufacturing operations that include approving and releasing, or rejecting, each finished batch for distribution, as required by 21 CFR 111.123(a)(8). Specifically, your BPRs show that your Children’s Tonsillitis/Otitis (Lot 031722) and Immune Tonic (Lot 052422) were released for distribution on March 17, 2022, and May 24, 2022, respectively, without being reviewed and approved by your quality control personnel. You further indicated that quality control does not review and approve for release any of your multi-ingredient herbal tincture supplements. We note you have received complaints regarding customers receiving the products that seemed different from what they ordered. Your internal investigations have found that the ordered products were either incorrectly mixed or mislabeled.
We have reviewed your written response, which states, “All multi-dietary ingredient herbal tincture and glycerite supplements will be released for distribution by Quality Control before they are distributed to a customer or warehouse.” In your response, your firm appended a production and release record for your Children’s Tonsillitis/Otitis product, which is now called Children’s Tonsils and Ears Formula, Lots CTOF080122HV and CTOF080322HV. We cannot evaluate the adequacy of your corrective actions because the production and release records do not specify if any of the individuals signing the records are quality control personnel.
4. You failed to prepare a written master manufacturing record (MMR) that includes written instructions for corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5). Specifically, your Pouring Formulas instruction sheet, which you provided in response to our request for your MMRs for the Children’s Tonsillitis/Otitis and Immune Tonic, does not include a corrective action plan for use when a specification is not met.
We have reviewed your response, which included a copy of an updated MMR for your Children’s Tonsillitis/Otitis product, which is now called Children’s Tonsils and Ears Formula. However, this MMR still does not include the corrective action plan required by 21 CFR 111.210(h)(5). We also note there is no indication that the updated MMR will be reviewed and approved by your quality control personnel, as required by 21 CFR 111.123(a)(1).
5. Your batch production record (BPR) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, you indicated during the inspection that the pour sheets for the multi-tincture formulas are your BPRs. The pour sheets for the Children’s Tonsillitis/Otitis (Lot 031722) and Immune Tonic (Lot 052422) lacked the following required information:
a. The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
b. The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in the producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
c. The unique identifier that you assigned to the packaging and label used [21 CFR 111.260(d)];
d. A statement of the actual yield [21 CFR 11.260(f)];
e. The actual results obtained during any monitoring operations [21 CFR 111.260(g)];
f. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
g. Documentation that the finished dietary supplements meets specifications for identity, purity, strength, composition, and limits on contamination and for packaging and labeling [21 CFR 111.260(i)];
h. Documentation, at the time of performance, of the manufacturing of the batch including:
i. The initials of the person responsible for verifying the weight or measure or each component used in the batch [21 CFR 111.260(j)(ii)];
ii. The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(iv);
i. Documentation, at the time of the performance, or packaging and labeling operations, including:
i. The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labeling used, and then label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)];
ii. An actual or representative label, or cross-reference to the physical location of the actual or representative label specified in the master manufacturing records [21 CFR 111.260(k)(2)];
iii. 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)];
j. Documentation at the time of performance that quality control personnel:
i. Reviewed the batch production record [21 CFR 111.260(l)(1)];
ii. Approved and rejected any reprocessing or repackaging [21 CFR 111.260(l)(2)];
iii. Approved and released, or rejected, the batch for distribution, including the any reprocessed batch [21 CFR 111.260(l)(4)];
k. Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]; and
l. Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].
6. You 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 did not collect and hold reserve samples of your multi-tincture formulas, including your Children’s Tonsillitis/Otitis and Immune Tonic.
In addition, you failed to collect and hold reserve samples for each lot of packaged and labeled dietary supplements you distribute in the same container-closure system in which the packaged and labeled dietary supplement is distributed, as required by 21 CFR 111.83(b)(1). Specifically, although you collect and hold reserve samples of your single ingredient tinctures, you hold these samples in (b)(4); however, these products are shipped out in different 1-ounce, 2-ounce, 4-ounce, 16-ounce, 32-ounce, and 1-gallon amber bottles.
We have reviewed your response, which included a copy of the Children’s Tonsils & Ears Formula MMR, and find the corrective action to be inadequate to address the violation. The MMR states that the reserve sample is collected and bottled from the batch before the rest of the product is (b)(4) and has (b)(4) added to it. A reserve sample must be a representative sample of product, which means it must accurately portray the material being sampled (see 21 CFR 111.3). A reserve sample taken from a batch before that batch is (b)(4) and has additional ingredients added to it is not representative of that batch.
Misbranded Dietary Supplements
In addition, your Acute Kidney Stone Relief, Adult Cold & Flu, Allergy Aid, Antifungal Formula, Baby Cold & Flu, Children’s Antibiotic Formula, Children’s Asthma Formula, Children’s Tonsillitis/Otitis, Hemorrhoid Remedial, Pregnancy Cold and Flu Formula, Prostate Formula, Special Lyme Formula, Immune Tonic, Children’s Allergy Relief Formula, Lung Tonic COPD, Fibromyalgia Formula, Hepatitis C Formula Glycerite, Kidney Stone Remedial, PCOS Formula, Anti-Amoeba Formula, Children’s Antiparasite, Children’s Antifungal Formula, Antiparasite Formula, and Male Fertility Tonic products are misbranded dietary supplement within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. Your Acute Kidney Stone Relief, Adult Cold & Flu, Allergy Aid, Antifungal Formula, Baby Cold & Flu, Children’s Antibiotic Formula, Children’s Asthma Formula, Children’s Tonsillitis/Otitis, Hemorrhoid Remedial, Pregnancy Cold and Flu Formula, Prostate Formula, Special Lyme Formula, Immune Tonic, and Male Fertility Tonic products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient (in the absence of a standardized common name per Herbs of Commerce) used as required by 21 CFR 101.4(h).
2. Your Children’s Allergy Relief Formula and Special Lyme Formula 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 and/or incomplete. 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. Your Special Lyme Formula product label states “Suggested dosage: 10 drops 3x daily…”, but the serving size list 15 drops.
b. Your Children’s Allergy Relief Formula product label states “Dosage: 10-20 drops every 2 hours for 2 days, then 4 times a day”, but the serving size list 30 drops.
c. Your product labels fail to follow the common measure with the equivalent metric quantity as required by 21 CFR 101.9(b)(7)
3. Your Immune Tonic, Kidney Stone Remedial, Lung Tonic COPD, Fibromyalgia Formula, and Hepatitis C Formula Glycerite products are each 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 labeling of your products does not comply with 21 CFR 101.36. Specifically, the product labels fail to include the “Servings Per Container” in accordance with 21 CFR 101.36(b)(1)(ii).
4. Your PCOS Formula, Children’s Asthma Formula, Anti-Amoeba Formula, Children’s Tonsillitis/Otitis, and Children’s Antiparasite products are misbranded within the meaning of section 403(q)(5)(F) the Act [21 U.S.C § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. For example:
a. The title “Supplement Facts” on your product labels is not set full width of the nutrition label as required by 21 CFR 101.36(e)(1).
b. Your product labels lack a heavy bar beneath the subheading “Servings Per Container” required by 21 CFR 101.36(e)(6)(i).
c. Your product labels do not meet the requirements under 21 CFR 101.36(c)(2) and (c)(3), respectively in that the other dietary ingredients contained in the “Proprietary Blend” or other appropriate descriptive term are not declared indented under the “Proprietary Blend” in descending order of predominance by weight, and in a column or linear fashion.
Furthermore, your proprietary blends declare glycerin, water, and ethanol as dietary ingredients when it appears they are functioning as food additives and/or solvents.
d. Your product labels fail to declare the amount of proprietary blend per serving, in accordance with 21 CFR 101.36(b)(3)(ii).
e. The heading, “Amount Per Serving,” fails to be bolded and placed above the listed quantitative amount per serving in accordance with 21 CFR 101.36(e)(1).
f. The symbol that precedes “Daily value not established” fails to also be placed following the quantitative amount per serving of the proprietary blend rather than next to the word “Extract” in accordance with 21 CFR 101.36(c)(3).
g. Your Children’s Tonsillitis/Otitis product fails to declare the “Other ingredients” below the Supplement Facts label in accordance with 21 CFR 101.4(g).
b) Your Antiparasite Formula, Children’s Antifungal Formula, and Children’s Antiparasite products are misbranded within the meaning of section 403(w) of the Act [U.S.C. § 343(w)] because the labels fail to declare the major food allergen “black walnut” as required by section 403(w)(1) of the Act.
Section 201(pp) of the Act [U.S.C. § 321(qq)] defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded if it is not a raw agriculture commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
a. The word “Contains,” followed by the name of the food sources from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. 343(w)(1)(A)]; or
b. The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived [e.g. “Black Walnut” (Tree Nut)], except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source, or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C 343(w)(1)(B)].
Specifically, your Antiparasite Formula, Children’s Antifungal Formula, and Children’s Antiparasite product labels include “Contains a tree nut (Black Walnut)” on the principal display panel and the major allergen does not parenthetically follow the food source name”. Furthermore, a “Contains” statement must be printed immediately after, or adjacent to, the ingredient list. We note, that if a “Contains” statement is used to declare the source of the tree nut we would not object to just the type of tree nut being declared, e.g., “Contains black walnuts.”
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.
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