Curtis Jacquot dba Pacific BioLogic Co.
FDA issued a warning letter to Curtis Jacquot dba Pacific BioLogic Co. (Concord, CA) following a June 2023 inspection and July 2023 website review, finding that multiple dietary supplement products (ArteClear Circulation 2, Headache Release, Natura-Mune-2, Pain Release, and Attack 2) bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The company also committed numerous CGMP violations including failure to establish component/finished-product specifications, missing master manufacturing records and batch production records, inadequate complaint handling, and failure to collect reserve samples. FDA noted these are repeat violations from a 2014 warning letter and a 2015 regulatory meeting, and warned that failure to correct may result in seizure or injunction.
Flagged claims (15)
This formula is recommended to be included in a supplement support program when treating chronic deficiency-type diseases because of its superior balance and gentle strengthening qualities.
More recently there have been extensive clinical studies that have identified a number of compounds in them [fungi and mushrooms, ingredients in Natura-Mune 2] that ... inhibit bacterial, viral, and tumor growth.
ArteClear: Circulation 2…cardio-protective ...formula, ischemic heart disease, post heart attack recovery…
Regulates body pain and spasms due to trauma, sprains, or fractures. Best if taken during the critical first 24-48 hours after injury.
Cat's Claw and Pau d'Arcu[sic] [ingredients in Natura-Mune 2] are two well-known (and studied) South American herbs that have some similar properties. They have been used extensively to treat chronic illnesses and degenerative conditions.
Dosage ... Best taken at the very onset. May be helpful to prevent onset of a migraine if taken at the onset of symptoms.
adjusting dosage according to level of pain and trauma
Pacific BioLogic's Pain Release is a powerful supplement that provides natural support for those who suffer from chronic pain or inflammation. If you are looking for an effective solution to relieve pain and inflammation without resorting to over-the-counter painkillers or prescription medications, Pain Release may be just what you need.
Reduce the dosage and frequency as the condition improves.
Non-aspirin
Suggested Dosage ... Use higher dosage for more severe-immune compromised conditions.
If you suffer from frequent headaches or migraines, you know how debilitating they can be. Fortunately, Pacific BioLogic's Headache Release formula offers natural relief for headaches and migraines.
... Andrographis, Viola, Chrysanthemum Flower, Oregon Grape Root, and Licorice root. These herbs work well together to cover a very wide spectrum of bacterial and viral strains. Much research has been done on the benefits of Andrographis. Its properties include analgesic, anti-viral, anti-inflammatory, expectorant …
Circulation 2" is misbranded within the meaning of section 403(r)(6) in that the product makes structure/function claims but fails to bear the required dietary supplement disclaimer
Categories: Cold & Flu ... Oncology Support
Required actions (4)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these 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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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