Metamune Inc
FDA and FTC jointly issued a warning letter to Metamune Inc (doing business as Bodymune) in September 2021 regarding its 'DiabetesSupport' dietary supplement sold via its website, Facebook page, and Amazon storefront. The agencies determined that marketing claims positioning the product as a treatment, cure, or support for diabetes and pre-diabetes rendered it an unapproved new drug and a misbranded drug under the FD&C Act. The FTC separately issued a cease-and-desist demand, warning that unsubstantiated disease-treatment claims violate the FTC Act and could result in civil penalties of up to $43,792 per violation plus consumer refunds. Both agencies required written corrective action within fifteen working days.
Flagged claims (10)
Our research scientists combined many valuable ingredients in the right proportions to achieve maximum benefit. DiabetesSupport helps the body heal itself with reduced dependency.
Natural Diabetes Support Safe Effective Diabetes Health Pack Diabetes and pre‐Diabetes Supplement. . .
DiabetesSupport ‐ Natural Diabetes Support Diabetes Health Pack Optimal Nutrition Diabetes and pre‐Diabetes. . .
DiabetesSupport is an organic, all natural nutritional support for diabetes and pre‐diabetes.
DiabetesSupport helps the body heal itself with reduced dependency, making it the ideal natural diabetes control solution.
Each particular ingredient in DiabetesSupport has been recognized and used over centuries by different cultures for diabetes support.
DiabetesSupport Natural Diabetes Support
IDEAL FOR ANY DIABETIC SUPPLIES KIT ‐ Carry with you to remember to take regularly, keep your blood sugar levels under control …
Effective Prediabetes Diabetic Supplement
SAFE, SYNERGISTIC DIABETES SUPPORT SUPPLEMENT ‐ Our unique blend of Organic Herb Extracts, Organic Fruit Extracts and Organic Essential Oils brings sugar balance to help maintain desired blood sugar level.
Required actions (6)
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Notice is hereby given that you must cease and desist from making any claim that a product and prevent, treat, or cure diabetes without competent and reliable scientific evidence consisting of well‐controlled human clinical studies substantiating that the claims are true.
marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a disease may be subject to a civil penalty of up to $43,792 per violation pursuant to Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. § 45(m)(1)(B)
may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b)
Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order.
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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