American Chinese Natural Herbs, Inc.
FDA issued a warning letter to American Chinese Natural Herbs, Inc. (Garland, TX) following a February–March 2022 inspection, citing serious CGMP violations and widespread misbranding across approximately 13 dietary supplement products including Almond Plus, Stomach Miracle, King Kong, LIV-97, and others. CGMP violations included failure to establish component and finished-product specifications, inadequate master manufacturing records and batch production records, and absent quality control procedures. Misbranding violations included false or misleading quantity statements, missing allergen declarations (oyster), absent or improperly linked structure/function claim disclaimers, and failure to declare standardized common names and plant parts for botanical ingredients. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (7)
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.
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 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.
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).
Your product labels do not bear a symbol next to all structure/function claims linking the claims to the FDA disclaimer.
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.
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.
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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