Nupack Inc.
FDA issued a warning letter to Nupack Inc. (Elgin, IL) following a facility inspection and website review, finding that six dietary supplement products — Cardiag, Diabetech, Cleanse-CAMP, MACA, Kidney Cleanse, and Pure Psyllium Husk — bore disease-treatment and prevention claims that rendered them unapproved new drugs under the Act. Three products (Cardiag, Diabetech, MACA) were also deemed misbranded drugs for lacking adequate directions for use. Additionally, Cardiag, Cleanse-CAMP, and MACA 1000 mg were found adulterated due to serious CGMP violations including absent product specifications, master manufacturing records, and batch production records. FDA warned that failure to correct these violations may result in seizure and injunction.
Flagged claims (14)
MACA may helps [sic] to reduce erectile dysfunction.
Diabetech powder for Diabetics
It helps to reduce risk for repeat heart attacks and improving outcomes in patients with heart failure [heart disease] to lowering blood pressure and combat side effects of cholesterol lowering statins
Support to lower LDL Cholesterol
Diabetech (a)supports blood sugar control, (b) reduces inflammation, and (c) helps enhance insulin sensitivity
Relieves Constipation
[N]atural diabetic supplement powder mix for daily diabetes support
MACA may reduce blood pressure
It may help…..Lowering Cholesterol, and protecting against clots which can cause heart attacks and stroke
Can help….with the prevention of …..stroke and heart attack
This supplement helps…reduce inflammation
Helping in daily regulation of blood glucose levels
[H]ealthy alternative to over-the-counter laxatives…
It … may prevent high blood pressure
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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