Dr. Howard J. Loff, M.D.
Owner and CEO
Golden Lab LLC
2375 Saint Johns Bluff Rd S Ste 310
Jacksonville , FL 32246-2335
United States
Hloffmd@doctorsoptimalformula.comFEI 3010153130Issued May 26, 2022Office of Human and Animal Food Operations East Division IV
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010153130.
Violations5
Issue DateMay 26, 2022
Product TypeDrugs
StatusClosed
Closeout LetterApr 3, 2024
Letter Details
Firm
Golden Lab LLC
Location
Dr. Howard J. Loff, M.D.
Owner and CEO
Golden Lab LLC
2375 Saint Johns Bluff Rd S Ste 310
Jacksonville , FL 32246-2335
United States
Hloffmd@doctorsoptimalformula.com
FEI Number
3010153130
Country
United States
Issue Date
May 26, 2022
Issuing Office
Office of Human and Animal Food Operations East Division IV
Product Type
Drugs
Status
Closed
Closeout Letter
April 03, 2024
Summary
Golden Lab LLC was cited for marketing unapproved new drugs and misbranded products, specifically three ocular health supplement capsules sold under the DoctoRx's Optimal Formula and Alereve brand names. The company made disease claims on product labels and its website indicating the products were intended to treat, mitigate, or prevent conditions including glaucoma, ocular hypertension, and seasonal allergies—claims that classified them as drugs requiring FDA approval. Examples of violations included statements such as "Take if suffering from glaucoma or ocular hypertension" and "Reduces IOP & Increases Blood Flow" on labels, and marketing language describing the formula as "designed specifically for patients suffering from glaucoma, ocular hypertension, or those with a strong family history of glaucoma" on the company website. The inspection was conducted in November 2021 at the company's Jacksonville, Florida facility.