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FDA Warning Letter Explorer
Drugs · Feb 10, 2023

American Chinese Natural Herbs, Inc.

4 extracted findings · 6 model-assigned issue types

FDA source excerpt, selected passage

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.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Components & suppliers21 CFR 111.70(b)

Failed to establish component specifications for identity of dietary ingredients.

Supporting FDA text
Source excerpt · automated text-match check

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.

Production & process controls21 CFR 111.70(e)

Failed to establish finished product specifications for identity, purity, strength, composition, and contamination limits.

Supporting FDA text
Source excerpt · automated text-match check

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).

Production & process controls21 CFR 111.210

Failed to establish MMRs including all required elements.

Supporting FDA text
Source excerpt · automated text-match check

You failed to establish MMRs for your products that include all elements required by 21 CFR 111.210.

Records & data integrity21 CFR 111.255(a)

Failed to prepare batch production records for every batch manufactured.

Supporting FDA text
Source excerpt · automated text-match check

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).

Records & data integrity21 CFR 111.260

BPRs lacked complete information as required.

Supporting FDA text
Source excerpt · automated text-match check

Your BPRs for Stomach Miracle, Thorough Wax Extract, and Almond Plus did not include complete information as required by 21 CFR 111.260.

Complaints & adverse event reporting21 CFR 111.553

Failed to establish and follow written procedures for product complaints.

Supporting FDA text
Source excerpt · automated text-match check

You failed to establish and follow written procedures to fulfill the requirements of Subpart O (Product Complaints), as required by 21 CFR 111.553.

Quality unit & oversight21 CFR 111.103

Failed to establish written procedures for quality control operations including material review and disposition.

Supporting FDA text
Source excerpt · automated text-match check

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.

Labeling, claims & marketing21 CFR 101.36(a)

Almond Plus label fails to present nutrition information as a supplement facts label.

Supporting FDA text
Source excerpt · automated text-match check

Your Almond Plus (300 pills) product label fails to present the nutrition information in the form of a supplement facts label.

Labeling, claims & marketing21 CFR 101.3(g)

Almond Plus label lacks statement of identity as a dietary supplement.

Supporting FDA text
Source excerpt · automated text-match check

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).

Labeling, claims & marketing21 CFR 101.4 21 CFR 101.36

Labels fail to declare common or usual name of each ingredient.

Supporting FDA text
Source excerpt · automated text-match check

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.

Labeling, claims & marketing21 CFR 101.36(d)(1) 21 CFR 101.4(h)(1)

Labels fail to identify plant part for botanical ingredients.

Supporting FDA text
Source excerpt · automated text-match check

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).

Labeling, claims & marketing21 CFR 101.15(c)

Bilingual labels fail to repeat all required information in both languages.

Supporting FDA text
Source excerpt · automated text-match check

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.

Labeling, claims & marketing

Labels are false and misleading due to inconsistent amounts.

Supporting FDA text
Source excerpt · automated text-match check

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.

Labeling, claims & marketing21 CFR 101.9(b) 21 CFR 101.12(b)

Serving size declared on label is incorrect.

Supporting FDA text
Source excerpt · automated text-match check

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.

Labeling, claims & marketing21 CFR 101.36

Labels fail to include quantitative amount by weight per serving size.

Supporting FDA text
Source excerpt · automated text-match check

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.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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:
21 CFR 111.70(b)
02
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:
21 CFR 111.210 21 CFR 111.210(a)
03
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.
21 CFR 111.255(a) 21 CFR 111.260
04
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
21 CFR 111.103

What FDA requested

Model-assisted summary. Consult the letter for complete requests and conditions.

  • Provide documentation showing that your firm has established component specifications.
  • Provide documentation showing that your firm has established finished product specifications.
  • Provide examples or documents showing implementation of electronic batch production records.
  • Provide examples of new standard operating procedures for quality control operations.
  • 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 used in the manufacture of the Thorough Wax Extract dietary supplement.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 101.4(h)(2)21 CFR 111.26021 CFR 111.21021 CFR 101.3621 CFR 111.70(b)21 CFR 111.70(e)21 CFR 111.210(a)21 CFR 111.210(b)21 CFR 111.210(c)21 CFR 111.210(d)21 CFR 111.210(e)21 CFR 111.210(g)21 CFR 111.210(h)21 CFR 111.210(h)(1)21 CFR 111.210(h)(2)21 CFR 111.210(h)(3)21 CFR 111.210(h)(3)(i)21 CFR 111.210(h)(3)(ii)21 CFR 111.210(h)(3)(ii)(A)21 CFR 111.210(h)(3)(ii)(B)21 CFR 111.210(h)(4)21 CFR 111.210(h)(5)21 CFR 111.255(a)21 CFR 111.260(d)21 CFR 111.260(f)21 CFR 111.260(g)21 CFR 111.260(h)21 CFR 111.260(i)21 CFR 111.260(k)21 CFR 111.260(l)21 CFR 111.260(n)21 CFR 111.55321 CFR 111.560(a)21 CFR 111.10321 CFR 101.36(a)21 CFR 101.3(g)21 CFR 101.421 CFR 101.36(d)(1)21 CFR 101.4(h)(1)21 CFR 101.15(c)21 CFR 101.9(b)21 CFR 101.12(b)21 CFR 101.93(b)21 CFR 101.4(g)21 CFR 101.36(c)(2)21 CFR 101.2(e)21 CFR 111

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