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In September, the U.S. Food and Drug Administration (FDA) sent warning letters to eight companies, including six homeopathic product manufacturers, for “manufacturing or marketing ophthalmic drug products in violation of federal law.”
According to FDA, the letters are part of an ongoing effort to crack down on ophthalmic products that are illegally marketed to treat conditions such as conjunctivitis, cataracts and glaucoma.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” said Jill Furman, director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.”
The eight companies involved are Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc, OcluMed, Similasan, TRP Company Inc and Walgreen Boots Alliance.
According to The American Association of Homeopathic Pharmacists (AAHP), six of the letters were sent to homeopathic product manufacturers of which four were cited for cGMP (current good manufacturing practices) violations.
“Despite homeopathic products being involved in six of the eight warning letters, it would be premature to consider this action part of an FDA targeting homeopathy,” AAHP said in a statement. “FDA has been concerned about eye care products for several years.”
“Although neither FDA nor Boiron identified any safety or quality issues with Optique 1 eye drops, Boiron decided to discontinue marketing this produce in the United States,” said Deborah Kelly, director of public relations for Boiron USA (Newtown Square, PA).
Similasan AG, a company based in Switzerland, said it voluntarily suspended the sale of its eye drop products pending further discussions with FDA.
“We are aware of recent concerns involving some competitors’ eyecare products, where flaws in product design and manufacturing resulted in a number of documented adverse events,” Similasan said in a statement. “However, those products and issues are completely unrelated to our company, our processes, our products or our ingredients.”
In August, two brands of methylsulfonylmethane (MSM) eye drops, Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair, were pulled for bacterial and/or fungal contamination. MSM is not approved for use in the United States, according to FDA.
The investigation is ongoing, according to FDA.
