Golden Lab LLC
FDA issued a warning letter to Golden Lab LLC (Jacksonville, FL), owned by Dr. Howard J. Loff, M.D., following a November 2021 facility inspection. The agency found that three ocular health supplement products — DoctoRx's Optimal Formula Ocular Pressure & Optic Nerve Support Formula, Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule — bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The letter also cited multiple cGMP violations including missing finished-product and component specifications and incomplete batch production records. FDA warned that failure to correct these violations may result in seizure and injunction.
Flagged claims (11)
Our ocular Pressure & Optic Nerve Support Formula was designed specifically for patients suffering from glaucoma, ocular hypertension, or those with a strong family history of glaucoma.
Reduces risks of photochemical damage from effects of Blue Light
Relief from symptoms associated with ocular allergies and sinus pressure
MitrogenolTM is clinically proven to reduce intraocular pressure by up to 25% without the side effects.
Reduces IOP & Increases Blood Flow
This constant bombardment from cell phones, tablets, computers, televisions, etc. poses a particular threat to those either suffering from or with a predisposition to Macular Degeneration.
Take if suffering from glaucoma or ocular hypertension
For those with genetic predisposition to AMD [Age-Related Macular Degeneration], and in addition with a history of smoking, family history of AMD, 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, and should be included in the diet for those susceptible
Developed by leading Ophthalmologists specializing in allergies, Alereve has developed an all-natural, proprietary blend that is positioned to be the therapy of choice for patients with ocular allergies, treating the patient's underlying allergic condition without the unwanted side-effects of dryness.
Alereve was developed to better treat patients' ocular allergies without exacerbating their dry eye component in fact, our initial study demonstrated that some patient's Dry Eye Syndrome was significantly improved with Alereve treatment
Relief from Symptom of OSD [Ocular Surface Disease] *Without the Side Effects of Antihistamines
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 address any 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.
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