Anabolic Laboratories Inc
FDA issued a warning letter to Anabolic Laboratories Inc. (Lake Forest, CA) in November 2022 after reviewing website claims for two products — CoQ10 Ubiquinol Prime and Policosanol Microtabs — that characterized them as intended for treatment of cardiovascular disease, heart failure, cholesterol management, and related conditions. These claims caused the products to be classified as unapproved new drugs under the FD&C Act, and CoQ10 Ubiquinol Prime was additionally found to be misbranded for lacking adequate directions for use. FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (5)
[I]mprovement in plasma CoQ10 was correlated with both clinical improvements and improvement in left ventricular function in heart failure patients
In patients undergoing surgery for cardiopulmonary bypass, those receiving CoQ10 treatment were significantly less likely to require inotropic drugs after surgery and to develop ventricular arrhythmias. Also, a randomized controlled multicenter trial evaluated CoQ10 as adjunctive treatment in 420 patients with chronic heart failure. Long- term CoQ10 treatment was found to be safe, improve symptoms, and reduce major adverse cardiovascular events. In another study, the administration of CoQ10 to heart transplant candidates led to significant improvements in functional status, clinical symptoms, and quality of life.
Naturally contains eight other higher primary aliphatic acids that assist in lowering cholesterol
Contains over 50% Octacosanol, ...found to manage lipid accumulation in fatty tissue and oxidation in the blood stream
The ubiquinol form of CoQ10 is beneficial for people who may have increased needs for CoQ10 or who are at high risk for decreased conversion of ubiquinone to ubiquinol, such as those on statins or other CoQ10 depleting medications, older individuals, and those with certain health conditions, especially heart disease.
Required actions (2)
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.
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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