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Posted June 30, 2022

FDA Warns Seller of Vision and Allergy Supplements

On May 26, 2022, the FDA issued a warning letter to Golden Lab LLC following an inspection of the website, which found statements about the company’s DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule products to be drug claims.

For example, the company’s website promoted DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule with statements such as, “For those with genetic predisposition to AMD [Age-Related Macular Degeneration]…or lightly-colored eyes should vigorously protect themselves from the risks associated with screen addiction and blue light. Meso Plus Astaxanthin contains the essential nutrients necessary.” Alereve Seasonal Allergy Ocular Support Capsule was promoted for “symptoms associated with ocular allergies and sinus pressure,” and “Without the Side Effects of Antihistamines.”

Inspection of the company’s manufacturing facility also found products to be adulterated because they were held in conditions that do not meet Current Good Manufacturing Practice (cGMP) for dietary supplements. These violations included failure to ensure the purity, strength, and composition of products as well as incomplete documentation relating to the production and control of product batches.

The company has 15 days to respond to the FDA in writing to explain the specific steps taken to address any violations.

See ConsumerLab’s Astaxanthin Supplements Review and Vision Supplements Review for tests of related products.

Also see ConsumerLab’s answer to the question: Which supplements are best for seasonal allergies?

For more information, use the link below.

Warning Letter: Golden Lab LLC

See related recalls and warnings:

Seller of Vision Supplements Warned by FDA

Seller of Omega-3, Ginkgo, Vision Supplements & More Warned for Drug Claims

Seller of Sexual Enhancement, Cholesterol, Resveratrol Supplements and More Warned For Drug Claims

Seller of Astaxanthin, Cinnamon, Pine Bark and More Warned for Manufacturing Violations

Allergy Bee Nasal Swabs Recalled Due to Potential Contamination With Yeast, Mold & Bacteria