Formulation Technology, Inc.
FDA issued a warning letter to Formulation Technology, Inc. (Oakdale, CA) following a facility inspection in October–November 2023, citing violations across three categories: marketing a product as an unapproved new drug (with disease-treatment claims implying migraine cure/mitigation), adulterated dietary supplements due to cGMP failures (missing heavy metal and strength specifications), and misbranded dietary supplements due to incorrect serving size declarations and non-compliant Supplement Facts labeling. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (3)
The product name implies the product is intended to cure, mitigate, treat, or prevent migraines.
(b)(4).
(b)(4).
Required actions (2)
Please notify FDA in writing, within 15 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.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker