Lumina Health Products, Inc. – FDA Warning Letter, Nov 30, 2012

The FDA issued a Warning Letter to Lumina Health Products, Inc. following a November 2012 inspection and a review of their website labeling in February and April 2013. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, several products (CELLFOOD, CELLFOOD Natural Weight Loss Formula, CELLFOOD SAM-e Liquid Formula, CELLFOOD Essential Silica Formula) were deemed unapproved new drugs due to disease claims on promotional materials and the website, violating Sections 201(g)(1)(B), 201(p)(1), and 505(a) of the Act. These products were also misbranded under Section 502(f)(1) for lacking adequate directions for use.

CGMP violations included failures to establish written procedures for quality control operations, material review, disposition, and approval for product release (21 CFR 111.103, 111.140(b)(1), 111.127(h)). The firm also failed to establish specifications for received products (21 CFR 111.70(f)), written procedures for returned dietary supplements (21 CFR 111.503), packaging and labeling operations (21 CFR 111.403), product complaints (21 CFR 111.553), and holding/distribution operations (21 CFR 111.453). Furthermore, multiple products were misbranded under Section 403(q)(5)(F) and 21 CFR 101.36 due to various labeling deficiencies, such as incorrect proprietary blend formatting, failure to list individual ingredients, improper placement of non-dietary ingredients, and incorrect Supplement Facts panel formatting. The firm's responses to the FDA 483 were deemed inadequate. Additional deficiencies noted included a lack of data to support product expiration dates and failure to perform identity testing for all dietary ingredients. The FDA requires prompt corrective action within 15 working days, with potential enforcement actions like seizure or injunction for non-compliance, and may assess re-inspection fees.