Supersmart USA, LLC
FDA issued a warning letter to Supersmart USA, LLC (Miami, FL) in January 2026 after reviewing their website and finding that eleven dietary supplement products — including Berberine, Aminoguanidine HCL, Glucofit, Super DHA, Celadrin, and others — bore disease-treatment and drug-effect claims that caused them to be regulated as unapproved new drugs under the FD&C Act. The claims covered blood sugar regulation, anti-inflammatory effects, cardiovascular disease prevention, joint pain relief, and treatment of depression, among others. Super DHA was additionally cited as a misbranded drug for lacking adequate directions for use for conditions requiring licensed-practitioner supervision. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (21)
Helps regulate blood sugar …
Helps reduce inflammation in the body
Enhanced natural berberine supplement (obtained from the root of Berberis aristata), 10 x more bioavailable than standard berberine, with multiple benefits for blood sugar and cholesterol
Designed to reduce joint pain and inflammation.
Helps reduce symptoms of venous insufficiency and haemorrhoids [sic]
Celadrin Supplement – Anti-Inflammatory Formula for Joint Pain Relief.
Has anti-inflammatory properties
Super DHA is a fish oil-based supplement for preventing cardiovascular problems
Beneficial for the prevention of coronary disease and the treatment of depression
Protects against…. neurodegenerative processes.
Reduces certain risk factors for cardiovascular disease and lowers the risk of recurrent heart attacks
Helps lower blood glucose and cholesterol levels
Helps restore vein function and optimal circulation
Effective anti-inflammatory to help reduce joint and bone pain.
Celadrin® is an anti-inflammatory complex of esterified carbon fatty acids.
Gymnema sylvestre supplement for regulating blood sugar levels
May relieve the inflammatory pain associated with osteoarthritis, rheumatoid arthritis, and tendonitis.
[O]ften lowers blood glucose levels
Can exert anti-inflammatory, hypoglycaemic, hypotensive and hypolipidemic effects
Ultra-bioactive berberine supplement: blood sugar, LDL...
Helps to control blood glucose levels
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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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