WARNING LETTER
MYA International, Inc.
MARCS-CMS 619877 —
February 24, 2022
Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Michael (NMI) Martins
Recipient Title
CEO/Owner
MYA International, Inc.
3517 Main St Ste 304
Chula Vista
,
CA
91911-0800
United States
Issuing Office:
Office of Human and Animal Food Operations –West Division 5
United States
WARNING LETTER
February 24, 2022
WL # 619877
Dear Dr. Martins:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility MYA International, Inc., located at 3517 Main St Ste 304, Chula Vista, CA, on 8/30/2021-9/3/2021, 9/8/2021, and 9/10/2021. Based on the inspection and our subsequent review of product labeling collected during the inspection, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find copies of the Act and related regulations through links on FDA’s home page at
www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
The Food and Drug Administration (FDA) reviewed your product labels for Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper following this inspection. The claims on your product 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 on your product labeling in your 2021 MYA International Catalog that provide evidence that your products are intended for use as drugs include:
HYGLY and Diapro-Z products:
The catalog in Spanish states:
Under the category “AUXILIAR EN PROBLEMAS DE DIABETES”
“Poderosa combinación de dos fórmulas diseñadas para ayudar a estabilizar los problemas de niveles de glucosa en la sangre y ayudar a mantener una regulación de su metabolismo reduciendo así la necesidad de insulina y ayudando a regular los niveles de azúcar en la sangre . . .”
Which translates in English to:
Under the category “Diabetes Problems Assistant”:
“Powerful combination of two formulas designed to help stabilize blood glucose problems and help maintain regulation of your metabolism thereby reducing the need for insulin and helping to regulate blood sugar levels . . .”
Bioampixilina product:
The product name “ampixilina” in Spanish translates to “ampicillin” in English. (Ampicillin is an antibiotic used to treat infections.)
The product label image in the catalog states “Natural Antibiotic Qualities.”
The catalog in Spanish states:
“[A]yuda con las infecciones como influenza, anginas, gripe, y afecciones del sistema respiratorio. Este suplemento con cualidades antibióticas naturales de amplio espectrum [sic] es efectivo contra muchos procesos bacterianos.”
“Ayuda en infecciones como:
o Influenza
o Anginas
o Gripe
o Afecciones del sistema respiratorio”
Which translates in English to:
“Helps with infections such as influenza…tonsillitis, flu, and respiratory system conditions. This supplement with natural antibiotic qualities of wide spectrum [sic] is effective against many bacterial processes.”
“Helps in infections like:
o Influenza
o Anginas
o Flu
o Diseases of the respiratory system”
Penalin product:
The catalog in Spanish states:
“Penalin es un producto directo del extracto de ajo. El ajo se llama espantaenfermedades.... Estudios señalan que el ajo combate el colesterol … reduce la presión sanguínea, es antiinflamatorio, evita resfriados, mejora el asma.”
Which translates in English to:
"Penalin is a direct product of garlic extract. Garlic is known to ward off diseases .... Studies show that garlic fights cholesterol ... lowers blood pressure, is anti-inflammatory, prevents colds, improves asthma.”
Colloidal Silver product:
The catalog in Spanish states:
Under the category “AUXILIAR EN PROBLEMAS DE CANCER Y TUMORES”:
“Es un poderoso auxiliar … que inactiva las enzimas de todas las células bacterianas, hongos, y virus que están usando para su metabolismo del oxígeno causando entonces su sofocación en 6 minutos o menos. Ayuda en: parásitos, herpes, fatiga crónica, en la piel ayuda en el acné, heridas abiertas, pie de atleta, conjuntivitis o irritaciones.”
Which translates in English to:
Under the category “Assistant in Cancer and Tumors Problems”:
“It is a powerful helper...that inactivates the enzymes of all bacterial cells, fungi, and viruses that are using oxygen for their metabolism, causing them to suffocate in 6 minutes or less. Helps in: parasites, herpes, chronic fatigue, on the skin helps with acne, open wounds, athlete’s foot, conjunctivitis or irritations.”
Tea (Tea Cellular) product:
The catalog in Spanish states:
Under the category “AUXILIAR EN PROBLEMAS DE CANCER Y TUMORES”:
“Combinación de extractos de plantas purificadoras que ayudan a identificar, reunir y eliminar toxinas del cuerpo. Es de gran ayuda en el control de: cáncer, artritis, diabetes, alergias, infecciones, problemas circulatorios, … disminuye el dolor, la inflamación, y rigidez de las articulaciones.”
Which translates in English to:
Under the category “Assistant in Cancer and Tumors Problems”:
"This combination of purifying plant extracts helps identify, gather, and eliminate toxins from the body. It is of great help in the control of: cancer, arthritis, diabetes, allergies, infections, circulatory problems ...reduces pain, inflammation, and joint stiffness"
Quiebra Piedras product:
The catalog in Spanish states:
“La actividad antiespasmódica de los alcaloides de Chancapiedra demostró ligera relajación muscular específica para el tracto urinario y biliar, por lo que los investigadores atribuyeron facilidades para la expulsión de cálculos de vejiga y riñón.
PRINCIPALES USOS: … elimina las obstrucciones, erradica los cálculos, reduce las inflamaciones, . . . desintoxica el hígado, … reduce el nivel de azúcar en la sangre, reduce la presión sanguínea y el colesterol.”
Which translates in English to:
“The antispasmodic activity of the stone crushing alkaloids showed slight muscle relaxation specific to the urinary tract and bile duct, for which the researchers attributed facilities an ease in the expulsion of bladder and kidney stones.
“MAIN USES: … eliminate obstructions, eradicate stones, reduce inflammation, … detoxify the liver, … reduces blood sugar levels, reduces blood pressure and cholesterol.”
Shark Cartilage product:
The catalog in Spanish states:
Under the category “AUXILIAR EN PROBLEMAS DE CANCER Y TUMORES”:
“Posee cualidades auxiliares como antiinflamatorias, analgésicas …. Estas propiedades lo convierten en un aliado del tratamiento contra el cáncer. Contiene sustancias … que ayudan padecimientos como el lupus y psoriasis.”
Which translates in English to:
Under the category “Assistant in Cancer and Tumors Problems”:
“Has auxiliary qualities as an anti-inflammatory, analgesic …. These properties make it an ally of the treatment of cancer. Contains substances … that help ailments such as lupus and psoriasis.
Helper product:
The catalog in Spanish states:
“Es un suplemento excepcional para niños que sufren de desórdenes o hiperactividad, esquizofrenia, bi-polaridad, depresión, problemas de memoria tipo Parkinson. También auxilia contra … insomnio ….”
Which translates in English to:
“It is an exceptional supplement for children who suffer from disorders or hyperactivity, schizophrenia, bipolarity, depression, Parkinson's-like memory problems. It also helps against … insomnia ….”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper 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 their intended purposes. Accordingly, Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper fail to bear adequate directions for their intended use and, therefore, the products 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 inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Additionally, even if your Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper were not unapproved new drugs and misbranded drugs, these products would be adulterated dietary supplements under section 402(g)(1) of the Act.
The violations include the following:
1. For each dietary supplement that you manufacture, you failed to establish specifications 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 did not establish specification for identity, purity, strength, and composition of your dietary supplement products.
Once you establish finished product 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, and composition [21 CFR 111.75(c)].
We have reviewed your response dated September 24, 2021, and have determined that your response fails to correct the deficiency identified during the inspection. In your response you stated that you “will develop a Finished Product Evaluation Form (FPEF) to include product specifications” for each finished product. As an example, you provided an FPEF for the product Impo-Frigi. The FPEF you provided fails to satisfy the requirements for finished product specifications because this form indicates that the strength and composition of the ingredients Maca Root, Ginseng Siberian, Damiana Leaf, Saw Palmetto, Valerian Root, and Ginkgo Biloba in the dietary supplements will all be determined by input only. Input is not a scientifically valid method to determine strength at the finished product stage.
2. You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you did not establish component specifications that are necessary to ensure that specifications for the identity, purity, strength, composition and limits on contamination of the dietary supplements manufactured using the components are met. For example, you have not established such component specifications for:
The Echinacea purpurea, Golden Seal, Bee Porpolis 70%, and Parsley Leaf used to manufacture your finished dietary supplement product Bioampixilina.
The Burdock Root Powder, Sheep Sorrel, Slippery Elm Bark, Watercress, Rhubarb Root, and Cinnamon Chips/Powder in your finished dietary supplement product Tea.
The Magnesium Chloride in your finished dietary supplement product Magnesium.
The Slippery Elm, Psyllium Husk, Fennel Seed, Licorice Root, Rhubarb Root, and Calcium Citrate in your finished dietary supplement product Intestinal Cleanser Part A.
The Maca Root, Ginseng Siberian Root, L-Arginine, Niacinamide, Damiana Leaf, Saw Palmetto Fruit, Valerian Officinalis Root Powder, and Gingko Biloba in your finished dietary supplement product Impo-Frigi.
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 confirm the identity of other components 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). You must also 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).
In addition, under 21 CFR 111.75(a)(2), you must either conduct appropriate tests or examinations or rely on a certificate of analysis (COA) from the supplier of the component that you receive, provided that the COA meets specific requirements. To the extent you receive dietary ingredients from suppliers from which you rely on a COA, you may only rely on a COA if the following conditions are met: (A) you first qualify the supplier by establishing the reliability of the supplier's COA through confirmation of the results of the supplier's tests or examinations; (B) the COA includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) you maintain documentation of how you qualified the supplier; (D) you periodically reconfirm the supplier's COA; and (E) your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier. We note that it does not appear that you have not qualified any suppliers by confirming the reliability of the COA.
We have reviewed your September 24, 2021 response and have determined that your response fails to correct the deficiency identified during the inspection. The documents that you purport to be component specifications, including those you provided for Echinacea purpurea, do not demonstrate that you have established specifications to ensure that specifications for the identity, purity, and strength of the dietary supplements manufactured using the components are met. For example, the document only states “Passed ID” for the identity specification for Echinacea, and the identity specification is not provided.
3. You failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a), and for your products in which you did prepare BPRs, your BPRs failed to 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 informed us during the investigation that you do not have BPRs for your Colloidal Silver product, and the executed BPRs you provided to our investigator for Bioampixilina 500mg capsules, lot number 0721315; Tea (Tea Cellular or Cat’s Claw Tea), lot number 0821421; Magnesium Liquid, lot number 821429; Intestinal Cleanser Part A, lot number 0821520; and Impro-Frigi, lot number 0821536, were incomplete as several sections, including sections related to production, were left blank, unsigned, or undated.
We have reviewed your September 24, 2021 response, and we have determined that it fails to correct the deficiency identified during the inspection. You stated that you have discontinued the product 670 Sodirite and that you will create a batch record for the 454 Colloidal Silver product. You also responded that for the incomplete batch production records, you would be updating the current versions to include written procedures and documentation for all key processing operations including double signature during key process steps, weights and lot numbers of components, label evaluation and control, blending specifications, in-process checks-on-weights and physical defects, yield reconciliation, major equipment and processing line identification, and quality review and release. However, your batch record templates already have locations/blank spaces on the forms to monitor processes such as entering weights and lot numbers of components, perform label evaluation and control, record blending specifications, reconcile yield, identify major equipment and processing lines, and sign and date for quality review and release. Your forms have most of the batch production record structure in place; however, it is necessary to determine that the staff is now entering/handwriting the information on these forms to complete the batch records. Your response also did not include any examples of BPRs created or revised and fully completed by your staff for review, which documentation could help demonstrate that the proposed corrective action has been implemented.
4. You failed to identify all processing lines and major equipment used during manufacturing to indicate their contents, including the name of the dietary supplement and the specific batch or lot number and, when necessary, the phase of manufacturing, as required by 21 CFR 111.365(k). Specifically, during the inspection, the investigator noticed that the capsule filling machine contained an unidentified brown powder inside the hopper and did not have any identification to indicate what contents were inside the hopper, or the name and lot number of the dietary supplement being encapsulated.
We have reviewed your September 24, 2021 response, and we have determined that it fails to correct the deficiency identified during the inspection. In your response, you stated that you are planning on developing a procedure for manufacturing control that will include the identification of equipment, status, and identification tag for lines used in manufacturing. You stated that you plan to create line, usage, maintenance and cleaning logs for each line, and provided blank examples of an identification tag and log page. However, you did not provide supporting documentation that you have implemented these corrective actions.
Misbranded Dietary Supplements
Your Magnesium, Intestinal Cleaner Part A, and Impo-Frigi products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101. In addition, even if your Tea, Penalin, Hygly, Diapro-Z, Colloidal Silver, Shark Cartilage, Quiebra Piedras, and Helper products were not unapproved new and misbranded drugs, these products would be misbranded under section 403 of the Act because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. Your Magnesium, Tea, Intestinal Cleaner Part A, Impo-Frigi, Penalin, Hygly, Diapro-Z, Colloidal Silver, Shark Cartilage, Quiebra Piedras, and Helper products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
2. Your Magnesium, Tea, Intestinal Cleaner Part A, Impo-Frigi, Penalin, Hygly, Diapro-Z, Colloidal Silver, Shark Cartilage, Quiebra Piedras, and Helper products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
3. Your Magnesium, Tea, Intestinal Cleaner Part A, Impo-Frigi, Hygly, Diapro-Z, Colloidal Silver, Shark Cartilage, Bioampixilina, Helper, and Quiebra Piedras products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36 and 101.9. For example:
a. Your Intestinal Cleaner Part A, Impo-Frigi, Hygly, Diapro-Z, Colloidal Silver, and Helper product labels declare several dietary ingredients but fail to express the amount of (b)(2)-dietary ingredients using the units of measurement given in 21 CFR 101.9(c) as required by 21 CFR 101.36(b)(2)(ii)(B) or the amount of (b)(3)-dietary ingredients using a metric measure as required by 21 CFR 101.36(b)(3)(ii)(A). Furthermore, your Helper product label fails to use the allowed abbreviation for micrograms for vitamin B12 listed in 21 CFR 101.9(d)(7)(i).
b. Your Magnesium product label declares “magnesium chloride” as a dietary ingredient. The quantitative amounts by weight shall represent the weight of the dietary ingredient rather than the weight of the source of the dietary ingredient (e.g., the weight of magnesium rather than that of magnesium chloride) [101.36(b)(2)(ii)]. The source of the dietary ingredient must be declared either within the Supplement Facts (for example, "magnesium (as magnesium chloride)") or in the ingredients statement [21 CFR 101.36(d)]. Furthermore, the %DV must be based on the quantitative amount of magnesium and not on the magnesium chloride.
c. Your Intestinal Cleaner Part A product label fails to declare calories, total carbohydrate, dietary fiber, and iron. The (b)(2)-dietary ingredients total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 21 CFR 101.9(c), as required by 21 CFR 101.36(b)(2)(i). Furthermore, the label bears an incorrect %DV for calcium based on the quantitative amount declared per serving.
d. Your Tea, Intestinal Cleanser Part A, Bioampixilina, and Diapro-Z product labels declare a proprietary blend but fail to indent the dietary ingredients under the term "Proprietary Blend" or other appropriately descriptive term or fanciful name. Furthermore, the labels fail to place the quantitative amount by weight specified for the proprietary blend on the same line to the right of that term, as required by 21 CFR 101.36(c)(2) and (3).
e. Your Impo-Frigi product label declares the (b)(2)-dietary ingredient niacin but fails to state the source of the niacin and the %DV, as required by 21 CFR 101.36(d) and 21 CFR 101.36(b)(2)(iii) respectively. Furthermore, the (b)(2)-ingredients must be listed first followed by a heavy bar and then (b)(3)-dietary ingredients, as required by 21 CFR 101.36(e)(6).
f. Your Helper and Hygly product labels fail to declare the (b)(2)-dietary ingredients and (b)(3)-dietary ingredients in the order and format prescribed in 21 CFR 101.36. The (b)(2)-dietary ingredients must be listed first in the order prescribed in 21 CFR 101.36(b)(2)(i) followed by a heavy bar and then (b)(3)-dietary ingredients.
g. Your Helper product label declares riboflavin as vitamin B2 and thiamin as vitamin B1. While these alternative names are acceptable synonyms for the listed vitamins, in accordance with 21 CFR 101.36(b)(2)(i)(B)(2), the synonym must parenthetically follow the name of the dietary ingredient. Furthermore, the label declares niacinamide and vitamin B5 which are not the nomenclature specified in 21 CFR 101.9 or 101.36(b)(2)(i)(B) for niacin or pantothenic acid, respectively. Additionally, the label fails to correctly list the %DV for each (b)(2)-dietary ingredient in accordance with 21 CFR 101.36(b)(2)(iii) and 21 CFR 101.9(c) and fails to indicate a Daily Value has not been established for the (b)(3)-dietary ingredient bee pollen, as required by 21 CFR 101.36(b)(3)(iv). Lastly, the label fails to declare the source of the vitamins. The source of each dietary ingredient must be designated on the label in accordance with 21 CFR 101.36(d).
h. Your Bioampixilina product label fails to set the title “Supplement Facts” in a type size larger than all other print size in the nutrition label, as required by 21 CFR 101.36(e)(1). Furthermore, your Bioampixilina, Penalin, Magnesium, Tea, Intestinal Cleaner Part A, Impo-Frigi, Hygly, Diapro-Z, Colloidal Silver, Shark Cartilage, Helper, and Quiebra Piedras product labels fail to present the nutrition information using the bolding, heavy bars, and other format requirements outlined in 21 CFR 101.36(e).
i. Your Bioampixilina product label fails to present the quantitative amounts of the dietary ingredients under the heading “Amount Per Serving” or “Amount Per 2 Capsules” as required by 21 CFR 101.36(b)(2)(i)(A). Furthermore, your Penalin, Magnesium, Tea, Intestinal Cleaner Part A, Impo-Frigi, Hygly, Diapro-Z, Colloidal Silver, Shark Cartilage, Helper, and Quiebra Piedras product labels use the term “Each Serving,” but this is not an acceptable name for the heading “Amount Per Serving.”
4. Your Hygly, Diapro-Z, Quiebra Piedras, and Penalin products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label fails to declare 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 Hygly and Diapro-Z product labels declare “Prostate Powder” which is not the common or usual name of an ingredient.
b. Your Penalin product is manufactured into capsules, but the product label fails to list each of the ingredients used to form the capsules.
c. Your Quiebra Piedras product label declares chanca piedra, but the standardized common name listed in the reference Herbs of Commerce is phyllanthus. Furthermore, the correct Latin binomial name is Phyllanthus niruri.
d. Your Helper product label declares Paba, but this is not the common or usual name for para-aminobenzoic acid.
5. Your Magnesium, Tea, Intestinal Cleanser Part A, and Colloidal Silver products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to correctly declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The label fails to express the net quantity of contents in terms of avoirdupois measure (gallon, pint, etc.) with any remainder in terms of ounces or common or decimal fractions of the measure, followed by the metric units as required by 1453(a) of the Fair Packaging and Labeling Act [15 U.S.C. § 1453(a)].
6. Your Tea, Impo-Frigi, Diapro-Z, and Bioampixilina products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
7. Your Magnesium, Tea, Colloidal Silver, Shark Cartilage, and Intestinal Cleanser Part A 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 label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b) and must be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams). Furthermore, 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. Your Shark Cartilage product’s suggested dose is 2 capsules, but the serving size lists 1 capsule. The serving size listed should be 2 capsules and quantitative amounts of dietary ingredients should be adjusted accordingly.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We offer the following comments:
1. Your full street address is not declared on the several of the product labels as required by 21 CFR 101.5(d); however, the street address may be omitted if it is shown in a current city directory or telephone directory.
2. Your Magnesium product label’s information panel includes nutrition information intermingled with information considered intervening material [21 CFR 101.2(e)]. Examples of intervening material include lot number and expiration date.
3. Your Magnesium, Colloidal Silver, Shark Cartilage, and Quiebra Piedras products list the “Other ingredients” in the (b)(3)-dietary ingredient section within the Supplement Facts label. The “Ingredients” or “Other Ingredients” must be listed outside and immediately following the Supplement Facts label as required by 21 CFR 101.4(g).
4. Your Tea product label misspells the dietary ingredient watercress, your Shark Cartilage product label misspells the dietary ingredient chondroitin sulfate, and your Impo-Frigi product label misspells the dietary ingredient
Ginkgo biloba
. Furthermore, the lower-case letter “g” appears to be partially truncated in the dietary ingredients Ginseng and L-Arginine on your Impo-Frigi label.
5. Some of the text on your Diapro-Z product label’s Supplement Facts is illegible.
6. Your Bioampixilina product label’s statement of identity must be in a size reasonably related to the most prominent printed matter on the principal display panel [21 CFR 101.3(d)].
7. Your Penalin product label bears the statement “Special Garlic Preparation.” 21 CFR 101 does not allow for such a statement within the Supplement Facts label.
8. Your Bioampixilina product label’s servings per container should be “15” and not “15 capsules.”
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild Irvine, CA 92612
Refer to Unique Identification Number CMS#619877 when replying.
If you have any questions regarding this letter, please contact Kimberly Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or 949-608-2967.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5
Content current as of:
05/03/2022
Regulated Product(s)
Drugs
Food & Beverages