Lopez Gonzalez Santana Corporation dba Domel and dba Dermixx

Detailed Analysis

False Claims and Regulatory Violations

Your Calci-Max product label claims “L-methylfolate” on the primary display panel, but the Supplement Facts label declares “methylfolate.”

Potential Health Risks

Consumers should be aware of potential risks associated with products from Lopez Gonzalez Santana Corporation dba Domel and dba Dermixx.

Regulatory Context

Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].

Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].

Be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample [21 CFR 111.83(b)(3)].