Warning Letter — OptiHealth Products, Inc.
The FDA issued a warning letter to OptiHealth Products, Inc. following an evaluation by the Human Foods Program regarding compliance concerns.
This action affects OptiHealth Products, Inc., as well as regulatory and quality assurance personnel responsible for food labeling and marketing claims.
The issuance of a warning letter by the Human Foods Program typically signifies that the agency has identified significant violations of the Federal Food, Drug, and Cosmetic Act. While the source does not detail specific violations, such letters often involve misbranding or the promotion of products with unauthorized health claims, which can lead to product seizures or injunctions if not remediated.
Review all digital and physical marketing assets to ensure health-related claims do not inadvertently classify food products as unapproved new drugs. Conduct a gap analysis between label claims and FDA food labeling requirements.
FDA Warning Letter issued to: OptiHealth Products, Inc.. 04/29/2026 — Human Foods Program. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/optihealth-products-inc-704899-04292026
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