Eden’s Answers, Inc.
FDA issued a warning letter to Eden's Answers, Inc. (Tampa, FL) following an August–November 2022 inspection of their Ohio manufacturing facility. The agency found serious CGMP violations related to inadequate identity and finished-product specifications, incomplete batch production records, and deficient master manufacturing records for dietary supplements including Dental Health, Honey Herbal Syrup, and Lil' Ones Sleepy Time. Additionally, the Honey Herbal Syrup and Sleepy Time product labels were found misbranded for failing to declare serving sizes, servings per container, and quantitative amounts per serving for each intended group. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (3)
The Honey Herbal Syrup and Sleep Time product labels are misbranded within the meaning of section 403(q)(5)(F) of the Act because the nutrition information in the Supplement Facts label is not declared for each intended group in accordance with 21 CFR 101.36(b)(2)(iii)(E). The quantitative amount of the Proprietary Blend per serving for each intended group needs to be declared.
The Honey Herbal Syrup and Sleepy Time product labels 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 for each intended group is not declared in the Supplement Facts label.
The Honey Herbal Syrup and Sleepy Time product labels are each misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because each label does not declare the number of servings per container for each intended group in the Supplement Facts label.
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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