WARNING LETTER
American Chinese Natural Herbs, Inc.
MARCS-CMS 631597 —
February 10, 2023
Delivery Method:
UPS Overnight Delivery
Signature Required
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Dr. Canh L. Duong
Recipient Title
Owner
American Chinese Natural Herbs, Inc.
2205 Executive Drive
Garland
,
TX
75041
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 3
1201 Main St., Suite 7200
Dallas
,
TX
75202
United States
WARNING LETTER
February 10, 2023
CMS# 631597
Dear Dr. Duong:
The U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 2205 Executive Drive, Garland, TX 75041 from February 15, 2022 through March 17, 2022, and we also reviewed labels for your products. Based on inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.
We received your written response dated March 29, 2022, written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We have reviewed that document and our comments on your response are listed following each of the significant violations.
Adulterated Dietary Supplements
The inspection of your facility revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the 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.
Your significant violations of CGMP requirements are as follows:
1. You failed to establish the required specifications for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you did not establish specifications for the components used for your dietary supplement products. For example, you have not established component specifications for the identity of the following dietary ingredients:
•
Thorough Wax Extract used in Hawthorn Plus, Super Dandelion Capsules, and Thorough Wax Extract product;
•
American Ginseng Extract used in Thorough Wax Extract;
•
Oyster Extract used in King Kong and Thorough Wax Extract;
•
Ginger Root used in Happy Smile Herb Blend;
•
Prunella Vulgaris used in Stomach Miracle;
•
Mulberry Leaf used in Stomach Miracle, Wooly, and Vital; and Bitter Almond Extract used in Almond Plus.
We have reviewed your response dated March 29, 2022. You state that you are obtaining monographs for ingredients from “
(b)(4)
” and that you are identifying tests and testing equipment such as HPLC; however, we are unable to evaluate the adequacy of your corrective actions because you did not provide documentation to show that your firm has established component specifications.
2. You failed to establish product 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, as required by 21 CFR 111.70(e). Specifically, you provided a product list with approximately 50 different types of products in different tablet or capsule numbers. You provided a sheet with a list of ingredients and weights for approximately 12 of your products. Your “specification sheets” only indicate the ingredients and weights.
We have reviewed your response dated March 29, 2022, and it is inadequate. With regards to your response for finished product identity specifications, your proposed corrective action of using organoleptic attributes (feel and color) along with microscopic photos of the powder within your capsules does not provide sufficient detail for your firm to be able confirm the identity of the finished product, and it does not ensure that you can distinguish one product from any other mix of powdered substances.
3. You failed to establish MMRs for your products that include all elements required by 21 CFR 111.210. Specifically, the MMR for your products Stomach Miracle, Thorough Wax Extract, and Almond Plus, failed to include the information required by 21 CFR 111.210, such as:
•
The name of the dietary supplement to be manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size, as required by 21 CFR 111.210(a);
•
A complete list of components to be used, as required by 21 CFR 111.210(b);
•
An accurate statement of the weight or measure of each component to be used, as required by 21 CFR 111.210(c);
•
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, as required by 21 CFR 111.210(d);
•
A statement of any intentional overage amount of a dietary ingredient, as required by 21 CFR 111.210(e);
•
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);
•
Written instructions, as required by 21 CFR 111.210(h), including the following:
o Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record as required by 21 CFR 111.210(h)(1);
o Procedures for sampling and a cross-reference to procedures for tests or examinations as required by 21 CFR 111.210(h)(2);
o Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.210(h)(3).
▪
Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component, as required by 21 CFR 111.210(h)(3)(i); and
▪
For manual operations, such specific actions must include, as required by 21 CFR 111.210(h)(3)(ii):
•
One person weighing or measuring a component and another person verifying the weight or measure, as required by 21 CFR 111.210(h)(3)(ii)(A);
and
•
One person adding the component and another person verifying the addition, as required by 21 CFR 111.210(h)(3)(ii)(B).
o Special notations and precautions to be followed, as required by 21 CFR 111.210(h)(4); and
o Corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5).
4. You failed to prepare a batch production record every time you manufactured a batch of dietary supplement as required by 21 CFR 111.255(a). Specifically, during the inspection, your firm did not have batch production records (BPRs) for all products that had been manufactured, such as Almond Plus and Stomach Miracle.
5. Your BPRs for Stomach Miracle, Thorough Wax Extract, and Almond Plus did not include complete information as required by 21 CFR 111.260. Specifically, your BPRs lack:
•
The unique identifier that you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used, as required by 21 CFR 111.260(d);
•
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing as required by 21 CFR 111.260(f);
•
The actual results obtained during any monitoring operation as required by 21 CFR 111.260(g);
•
The results of any testing or examination performed during the batch production, or a cross-reference to such results as required by 21 CFR 111.260(h);
•
Documentation that the finished dietary supplement meets specifications established in accordance with Sec. 111.70(e) and (g) as required by 21 CFR 111.260(i);
•
Documentation, at the time of performance, of the manufacture of the batch, including:
•
The date on which each step of the master manufacturing record was performed; and The initials of the persons performing each step, including: The initials of the person responsible for weighing or measuring each component used in the batch; The initials of the person responsible for verifying the weight or measure of each component used in the batch; The initials of the person responsible for adding the component to the batch; and The initials of the person responsible for verifying the addition of components to the batch results as required by 21 CFR 111.260 (j);
•
Documentation, at the time of performance, of packaging and labeling operations, including: The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; 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; and The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results as required by 21 CFR 111.260(k);
•
Documentation at the time of performance that quality control personnel: Reviewed the batch production record, including: Review of any monitoring operation required under subpart E of this part; and Review of the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements; Approved or rejected any reprocessing or repackaging; and Approved and released, or rejected, the batch for distribution, including any reprocessed batch; and Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement, as required by 21 CFR 111.260(l);
•
Documentation at the time of performance of any required material review and disposition decision, as required by 21 CFR 111.260 (m); and
•
Documentation at the time of performance of any reprocessing as required by 21 CFR 111.260(n).
In your response from March 29, 2022, you state that you are planning to implement electronic batch production records. You did not provide an example or documents showing your implementation of electronic batch production records, so we are unable to evaluate the adequacy of your corrective actions.
7. You failed to establish and follow written procedures to fulfill the requirements of Subpart O (Product Complaints), as required by 21 CFR 111.553. Specifically, you provided the investigator with a “Return Policy for product Complaints.” The policy states that you refund or exchange the product, that you refer to the “Batch Production Record” and that your quality control personnel reexamine the batch “to ensure [whether] the batch was contaminated.” It also states that if multiple reports and complaints are received “in a
(b)(4)
time span,” that the batch will be sent to a laboratory for testing. Your product complaint procedures failed to include that a qualified person will review all product complaints (not only on the basis of returned products) and will investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury, not only when you have multiple reports or complaints, as required by 21 CFR 111.560(a).
8. Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision as required by 21 CFR 111.103. Specifically, your firm did not establish written procedures that included procedures to follow for conducting a material review and make a disposition decision for each lot of finished dietary
supplement products manufactured and distributed under your own label name, American Chinese Natural Herbs.
Your firm’s March 29, 2022, response stated that you are in the process of developing new standard operating procedures however, we are unable to evaluate the adequacy of your corrective actions because you did not provide examples of those new standard operating procedures.
Misbranded Dietary Supplements
In addition, we reviewed product labels collected during the inspection and have determined that your Almond Plus (300 Pills), Almond Plus (600 pills), Stomach Miracle (120 capsules and 270 capsules), LIV-97, Yellow Dragon, King Kong, Vital, Happy Smile Herb Blend, Hawthorn Plus, Thorough Wax Extract, Woolly, and Super Dandelion Capsules 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. Specifically, we identified the following:
1. Your Almond Plus (300 pills) product is 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 product does not comply with 21 CFR 101.36(a). For example, your Almond Plus (300 pills) product label fails to present the nutrition information in the form of a supplement facts label.
2. Your Almond Plus (300 pills) product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
3. Your Almond Plus (300 pills and 600 pills), Stomach Miracle (120 capsules and 270 capsules), LIV-97, Yellow Dragon, King Kong, Vital, Happy Smile Herb Blend, Hawthorn Plus, Thorough Wax Extract, Woolly, and Super Dandelion Capsules 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 name of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. For example:
•
Almond Plus (300 pills and 600 pills):
o Declares red date and melissa but fails to declare the standardized common names jujube and lemon balm, respectively, as listed in the reference Herbs of Commerce (HOC).
o Declares mimosa, but this is not the common or usual name of a dietary ingredient.
o Sand is not in HOC; therefore, the Latin binomial must be declared in accordance with 21 CFR 101.4(h)(2).
•
Happy Smile Herb Blend:
o Declares glehniae, patriniae, longanae, ophiopogonis, polygalae, and astragail, but the standardized common names must be stated in English as glehnia, patrinia, longan, ophiopogon, polygala, and astragalus, respectively.
o Declares Ganoderma lucidum, Poria cocos, Zizphy spinosae, Nelumbinis, red date, and Coicis, but fails to declare the standardized common names reishi, poria, jujube, sacred lotus, jujube, and Job’s tears, respectively, as listed in HOC.
o Declares concha pteriae and atralodis, but these are not the common or usual names of dietary ingredients.
•
Hawthorn Plus:
o Declares nut grass, thorough wax, tree of heaven, and Indian bread, but fails to declare the standardized common names Cyperus, bupleurum, Chinese tree-ofheaven or Indian tree-of-heaven, and poria, respectively, as listed in HOC.
o Batavia and sand are not in HOC; therefore, the Latin binomial must be declared in accordance with 21 CFR 101.4(h)(2).
•
King Kong:
o Declares Rubi but this is not the common or usual name of a dietary ingredient.
•
LIV-97:
o Declares artemissa [sic], thorough wax, tree of heaven, neroli, tang kuei, and oldenlandia, but fails to declare the standardized common names sweet wormwood, bupleurum, Chinese tree-of-heaven or Indian tree-of-heaven, bitter orange, dong quai, and hedyotis, respectively, as listed in HOC.
o Declares dragons blood but fails to declare the standardized common name dragon’s blood croton which is indicated by the Latin binomial listed in the finished product specification sheet provided during the inspection.
o Batavia and sand are not in HOC; therefore, the Latin binomial must be declared in accordance with 21 CFR 101.4(h)(2).
o Declares cyperi but the standardized common name must be stated in English as cyperus.
•
Stomach Miracle:
o Declares Prunella vulgaris, Psoralea coryliflia, Verbena officinalis, Xanthium sibiricum, Eclipta prostrata, Mesoma [sic] chinensis, Curcuma longa L., Agrimonia Pilosa, Zea mays, and Ziziphus jujuba, but fails to declare the standardized common names heal all, psoralea, European vervain, xanthium, eclipta, mesona, turmeric, agrimony, corn, and jujube, respectively, as listed in HOC.
o Declares Oytrea densekamellosa [sic] but fails to declare the common or usual name oyster.
•
Super Dandelion Capsules
o Declares tang kuei, red peony, thorough wax, and tree of heaven, but fails to declare the standardized common names dong quai, Chinese peony, bupleurum, and Chinese tree-of-heaven or Indian tree-of-heaven, respectively, as listed in HOC.
o Declares origanum, silver, red, and liquidambaris, but these are not the common or usual names of dietary ingredients.
•
Thorough Wax Extract:
o Your product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules.
o Declares thorough wax and tang kuei, but fails to declare the standardized common names bupleurum, dong quai, respectively, as listed in HOC.
o Declares water lavage[sic], mimosa, origanum, silver, and liquidambaris, but these are not the common or usual names of dietary ingredients.
o Regarding the botanical ingredient “water lavage [sic] extract”, please provide the Latin Binomial (Genus and species) of the water lovage extract ingredient, the identity specification for the ingredient, a Certificate of Analysis from the supplier, and testing that can verify the identity of the ingredient you used in the manufacture of the Thorough Wax Extract dietary supplement. Some synonyms to Water Lovage are Water Hemlock or Hemlock Water Dropwort. These synonyms correspond to Oenanthe crocata L., which is a poisonous plant of the Apiaceae family.
•
Vital:
o Declares Polygonum aviculare L, Prunus japonica, Plumeria rubra L, Luffa cylindrica, Rubia cordifolia, and red date, but fails to declare the standardized common names knotweed, Japanese bush cherry, frangipani, luffa, Indian madder, and jujube, respectively, as listed in HOC.
o Declares mimosa, plantage, and acanthopanacis, but these are not the common or usual names of dietary ingredients.
•
Wooly:
o Declares woolly grass and shave grass but fails to declare the standardized common names imperata and giant horsetail, respectively, as listed in HOC.
o Declares plantage and cocklebur, but these are not the common or usual names of dietary ingredients.
•
Yellow Dragon:
o White man is not in HOC; therefore, the Latin binomial must be declared in accordance with 21 CFR 101.4(h)(2).
o Declares celadine, dogwood, and peony, but these are not the common or usual names of dietary ingredients.
o Declares Indian bread but fails to declare the standardized common names poria as listed in HOC.
o Your product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules.
4. Your Almond Plus (300 pills and 600 pills), Happy Smile Herb Blend, Hawthorn Plus, Stomach Miracle (120 capsules and 270 capsules), King Kong, LIV-97, Vital, Super Dandelion Plus, Thorough Wax Extract, Woolly, and Yellow Dragon 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 101.36(d)(1) and 21 CFR 101.4(h)(1). For example:
•
Happy Smile Herb Blend, Hawthorn Plus, Stomach Miracle (120 capsules and 270 capsules), Super Dandelion Capsules, and Vital:
o Not all ingredients indicate the plant part used. The label must list the English name of the plant part; for example, root instead of radix. Furthermore, herb (herba) does not describe the plant part; if the entire plant is used, indicate this by stating “whole plant.”
•
Almond Plus (300 pills and 600 pills):
o Red date, bitter almond, and wild yam do not indicate the plant part used.
•
King Kong:
o Asparagus extract, aged red ginseng extract, Dried Seal Extract, and Achyranthes Extract ingredients do not indicate the plant part used.
•
LIV-97:
o Artemissa [sic], Jasmine, dragons blood, Neroli, Tree of Heaven, Oldenlandia, Honey Suckle [sic] ingredients do not indicate the plant part.
•
Thorough Wax Extract:
o Thorough Wax Extract, Water Lavage [sic] Extract, American Ginseng Extract, and Origanum Extract do not indicate the plant part used.
•
Woolly:
o Woolly grass, bitter orange, and shave grass do not indicate the plant part used.
•
Yellow Dragon:
o Sea dragon extract, Indian bread extract, achyranthes extract, and water plantain extract do not indicate the plant part used.
5. Your Happy Smile Herb Blend products, Stomach Miracle (120 capsules and 270 capsules), and Vital products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages but do not repeat all the required information in both languages. As required by 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.
6. Your Happy Smile Herb Blend and Stomach Miracle (120 capsules and 270 capsules), and Vital products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labels are false and misleading. Specifically:
•
Your Happy Smile Herb Blend product label states each capsule contains 500 mg and the serving size is 3 capsules with the amount per serving as 1,500 mg, but the sum of the dietary ingredients listed in the Supplement Facts is 765 mg,. Therefore, according to list in the Supplement Facts panel, the amount per capsule would be 255 mg, which does not match the 500 mg listed on the label.
•
Your Stomach Miracle (120 capsules and 270 capsules), product labels state each capsule contains 500 mg and the serving size is 3 capsules with the amount per serving as 1,500 mg, but the sum of the dietary ingredients listed in the Supplement Facts is 1150 mg. Therefore, according to list in the Supplement Facts panel, the amount per capsule would be 383 mg, which does not match the 500 mg listed on the label.
•
Your Vital product label states each capsule contains 500 mg and the serving size is 3 capsules with the amount per serving as 1,500 mg, but the sum of the dietary ingredients listed in the Supplement Facts is 1210 mg. Therefore, according to list in the Supplement Facts panel, the amount per capsule would be 403 mg, which does not match the 500 mg listed on the label.
7. Your Almond Plus (300 pills and 600 pills), King Kong, LIV-97, Thorough Wax Extract, and Yellow Dragon 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 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. Specifically:
•
Your Almond Plus (300 pills and 600 pills) product label fails to list the serving size.
•
Your King Kong product label suggests consumers take 3-5 pills twice daily, but the serving size is 3 pills. The serving size should be 5 pills.
•
Your LIV-97 product label suggests consumers take 8-12 pills twice daily, but the serving size is 3 pills. The serving size should be 12 pills.
•
Your Thorough Wax Extract product label directs consumers to take 3-6 capsules 2 times daily, but the serving size is 3 capsules. The serving size should be 6 capsules.
•
Your Yellow Dragon product label suggests consumers take 2-5 capsules twice daily, but the serving size is 2 capsules. The serving size should be 5 capsules.
8. Your Almond Plus (300 pills and 600 pills), Hawthorn Plus, LIV-97, Super Dandelion Capsules, Thorough Wax Extract, Woolly, and Yellow Dragon products are misbranded within the meaning of section 403(s)(2)(A)(ii) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)] in that the product label fails to include the quantitative amount by weight per serving size of each dietary ingredient or fails to include the total quantitative amount by weight per
serving size of all dietary ingredients in a proprietary blend as required by 21 CFR 101.36.
9. Your LIV-97, Stomach Miracle (120 capsules and 270 capsules), Thorough Wax Extract, and Yellow Dragon products are 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). For example: Your product labels do not bear a symbol next to all structure/function claims linking the claims to the FDA disclaimer.
10. Your Stomach Miracle (120 capsules and 270 capsules) and Happy Smile Herb Blend products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product labels fail to declare the major food allergen oyster. Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines 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 the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
•
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
•
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. “Whey (Milk)”], 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 else-where in the ingredient list (unless the name of the food source that 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)].
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 Stomach Miracle (120 capsules and 270 capsules) and Vital product labels bear the statement of identity as “Herbal Food Supplement.” While “Herbal Supplement” is an appropriate statement of identity, the term “Food Supplement” is not appropriate because it does not identify or describe the dietary ingredients or combination of ingredients that the product supplies. Your Hawthorn Plus product label misspells the dietary ingredient betelnut and your Yellow Dragon label misspells the dietary ingredient teasel.
2. Your Happy Smile Herb Blend, Stomach Miracle (120 capsules and 270 capsules), Super Dandelion Capsules, Vital, and Woolly product labels list Other Ingredients: Gelatin (capsule) within the Supplement Facts label. The ingredients list should be located outside and directly below the Supplement Facts label in accordance with 21 CFR 101.4(g).
3. Your Happy Smile Herb Blend, Hawthorn Plus, Stomach Miracle (120 capsules and 270 capsules), Super Dandelion Capsules, Vital, and Woolly product labels fail to indent the dietary ingredients contained in the proprietary blend under the term “Proprietary Blend” as required by 21 CFR 101.36(c)(2).
4. Your Thorough Wax Extract product label’s information panel includes nutrition information intermingled with information that is considered intervening material. An example of intervening material is “Product contains no sugar, starch, ….” All information appearing on the information panel of the product label should appear in one place without other intervening material [21 CFR 101.2(e)].
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.
Please send your written response to the U.S. Food and Drug Administration, Attention: Chad J. Whitwell, Compliance Officer, at the following email: Chad.Whitwell@fda.hhs.gov (preferred) or you may also mail a hard copy addressed to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at 1201 Main St, Suite 7200, Dallas, TX 75202.
If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328 or by email.
/S/
Edmundo Garcia, Jr.
Program Division Director
Office of Human and Animal Food Operations – West Division 3
Content current as of:
02/14/2023
Regulated Product(s)
Dietary Supplements
Drugs