Inspections, Compliance, Enforcement, and Criminal Investigations

Macular Health 4/28/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

April 28, 2016
 
WARNING LETTER NO. 2016-NOL-04
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Jeffery McAnnally, President
Macular Health, LLC
1603 Decatur Highway
Gardendale, Alabama 35071
 
Dear Mr. McAnnally:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.macularhealth.com in March 2016 and has determined that you take orders there for your MacuStrip, Visual Advantage AREDS II Formula, Visual Advantage Premier Formula, Antioxidant Only Genetic Formula, Zinc Only Genetic Formula, Low Dose Zinc Genetic Formula, Blephadex Eyelid Wipes, Blephadex Eyelid Foam, and Visual Advantage Dry Eye Formula products.  The claims on your website establish that the products are drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United State Code (USC) 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.[1]  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Visual Advantage Dry Eye Formula
  • Product name is an implied drug claim
  • “Our new dry eye formula can help to reduce dry eye symptoms, including burning, stinging, redness and intermittent visual disturbances.”
  • “Macular Health’s new Visual Advantage Dry Eye Formula … contains the essential ingredients proven to benefit dry eye...” 
Antioxidant Only Genetic Formula, Zinc Only Genetic Formula, & Low Dose Zinc Genetic Formula
  • “For those who utilize genetic testing for macular degeneration.”
  • These products are referenced under the heading “Macular Degeneration” on your website, which implies that the products are intended for use in the cure, mitigation, treatment, or prevention of macular degeneration. 
Visual Advantage AREDS II Formula
  • “The study proven vitamin that doctors have been recommending for macular degeneration for years.”
  • “The Macular Health AREDS II formula is based upon the groundbreaking age-related eye disease study sponsored by the National Eye Institute (NEI).”
  • This product is referenced under the heading “Macular Degeneration” on your website, which implies that the product is intended for use in the cure, mitigation, treatment, or prevention of macular degeneration.  
MacuStrip
  • “MacuStrip™ was developed for Macular Degeneration sufferers…”
  • This product is referenced under the heading “Macular Degeneration” on your website, which implies that the product is intended for use in the cure, mitigation, treatment, or prevention of macular degeneration. 
Visual Advantage Premier Formula
  • “Macular Health's Visual Advantage™ now offers genotype-directed nutraceuticals for macular degeneration.”
  • This product is referenced under the heading “Macular Degeneration” on your website, which implies that the product is intended for use in the cure, mitigation, treatment, or prevention of macular degeneration. 
Blephadex Eyelid Wipes & Blephadex Eyelid Foam
  • “Our patented blend of Tea Tree Oil and Coconut Oil for itchy, scratchy and flaky eyelids.”
  • “Blephadex™ Science Base Lid Care is doctor recommended to help relieve the symptoms of Blepharitis and Demodex. By using Blephadex™ every other day, you can effectively remove excessive oils and debris that may cause your eyelids to be inflamed, red, itchy, or have dandruff-like scales.”
  • “Blephadex™ has been shown in clinical studies to reduce Bacterial Eyelid Colony Forming Units (CFU).”
  • The product names imply the products are intended for use in the cure, mitigation, treatment, or prevention of blepharitis.
  • The placement of the references to your “Blephadex Eyelid Wipes” and Blephadex Eyelid Foam” products under the heading “Blepharitis & Demodex” on your website implies that the products are intended for use in the cure, mitigation, treatment, or prevention of blepharitis and demodex. 
Your “MacuStrip,” “Visual Advantage AREDS II Formula,” “Visual Advantage Premier Formula,” “Antioxidant Only Genetic Formula,” “Zinc Only Genetic Formula,” “Low Dose Zinc Genetic Formula,” “Blephadex Eyelid Wipes,” “Blephadex Eyelid Foam,” and “Visual Advantage Dry Eye Formula” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under Section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in Sections 301(d) and 505(a) of the Act [21 USC 331(d), 355(a)].  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s).  “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in Section 503(b)(1)(A) of the Act [21 USC 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your “MacuStrip,” “Visual Advantage AREDS II Formula,” “Visual Advantage Premier Formula,” “Antioxidant Only Genetic Formula,” “Zinc Only Genetic Formula,” “Low Dose Zinc Genetic Formula,” “Blephadex Eyelid Wipes,” “Blephadex Eyelid Foam,” and “Visual Advantage Dry Eye Formula” products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your “MacuStrip,” “Visual Advantage AREDS II Formula,” “Visual Advantage Premier Formula,” “Antioxidant Only Genetic Formula,” “Zinc Only Genetic Formula,” “Low Dose Zinc Genetic Formula,” “Blephadex Eyelid Wipes,” “Blephadex Eyelid Foam,” and “Visual Advantage Dry Eye Formula” products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates Section 301(a) of the Act [21 USC 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
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.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 15 working days, state the reason for the delay and the time within which you will complete the correction.  
 
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Kimberly Dutzek, Compliance Officer, at the above address.  If you have questions, concerning the contents of this letter, you may contact Ms. Dutzek at 615-366-7826.                                                                                                                                                      
 
Sincerely,
/S/ 
Ruth P. Dixon
District Director
New Orleans District


[1] As defined in 21 CFR 101.93(g)(1), a “disease” is “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” 

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