Chambers' Apothecary
FDA issued a warning letter to Chambers' Apothecary (Robert Norris, Chambersburg, PA) after reviewing their website in October 2022 and finding that marketing claims for their Blood Pressure Support and CoEnzyme Q10 products established drug-intended use under the FD&C Act. Specific claims about lowering blood pressure, reducing cholesterol, and improving heart disease outcomes rendered these products unapproved new drugs. FDA also found both products misbranded for lacking adequate directions for use. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (8)
Coleus forskohlii [an ingredient in Blood Pressure Support] contains a chemical called forskolin, which is known for having the ability to reduce blood pressure.
May lower blood pressure
Taurine [an ingredient in Blood Pressure Support] is a naturally occurring amino sulfonic acid and may lower blood pressure
May decrease muscle breakdown, pain and discomfort for people taking statins.
research suggests Hawthorn extract (Crataegus oxyacantha) [an ingredient in Blood Pressure Support] may help control high blood pressure and cholesterol by increasing coronary artery blood flow and improving circulation.
May lower cholesterol
May improve health of blood vessels in those with ... heart disease.
Hops strobiles (Humulus lupulus) [an ingredient in Blood Pressure Support] contains specific flavonoids that have the potential to lower blood pressure
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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