Inspections, Compliance, Enforcement, and Criminal Investigations
EyeScience Labs, L.L.C. 9/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
Via United Parcel Service
WARNING LETTER CIN-12-319598
September 18, 2012
Jeffrey M. Northup, CEO and President
EyeScience Labs, L.L.C.
493 Village Park Dr.
Powell, OH 43065-6638
Dear Mr. Northup:
This letter is in reference to your firm’s distribution and promotion of EyeScience products, “Macular Health Formula,” “Dry Eye Formula,” and “Diabetic Vision Formula.” The Food and Drug Administration (FDA) has determined that these products are promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on the product labeling establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act. You can find the Act and FDA’s regulations through links via FDA’s home page at www.fda.gov.
Examples of claims observed on the labeling of your products include:
Macular Health Formula
• “THE MOST COMPLETE EYE VITAMIN FOR MACULAR DEGENERATION”
• “Age-related macular degeneration (AMD) is a hereditary and progressive eye disease that is the leading cause of blindness…At EyeScience, we believe in protection for those with all forms of AMD and prevention for those at risk. Our Macular Health Formula™ is one of the most complete nutritional supplements for eye health available today.”
Dry Eye Formula
• “EyeScience Dry Eye Formula is a physician-formulated, next-generation dietary supplement created to address the underlying causes of dry-eye syndrome.... [V]itamin therapy in conjunction with eye drops can help treat the cause, not just the symptoms…Our cutting edge formula targets the causes of dry-eye-syndrome from the inside out.”
Diabetic Vision Formula
• “EyeScience Diabetic Vision Formula is specifically formulated for diabetics to help promote ocular health. Diabetes can lead to diabetic retinopathy, a leading cause of blindness in the US..... [O]xidative stress is the underlying cause of blood vessel damage characteristic of diabetic retinopathy. Protect your eyes with our unique leading edge blend of vitamins, minerals, herbal extracts, amino acids, and antioxidants.”
Your products are drugs as defined by section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals. Moreover, these products are new drugs as defined by section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced uses. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].
Your Diabetic Vision Formula product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layperson can use the product safely for their intended uses. Thus, your product’s labeling fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction.
We also note that the labels for dietary supplements are required to identify the product using the term “dietary supplement” as part of the statement of identity on the principal display panel. Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] and 21 CFR 101.3(g). However, your Computer Eye Strain product label lacks this identification. If your other EyeScience products were considered dietary supplements, they would also be required to include this identification.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the above violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be sent to the U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237-3097, Attention: Karen Gale Sego, Compliance Officer.
Paul J. Teitell
cc: Director Charles Kirchner, Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399