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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
 
Telephone:         425-302-0340
FAX:                    425-302-0402 


July 22, 2016
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED


In reply refer to Warning Letter SEA 16-16

Dr. Jason Ko, President
Viva Nutraceuticals
J & E International Corporation
1365 Stonegate Way
Ferndale, Washington 98248-7824
 
WARNING LETTER

Dear Dr. Jason Ko:
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.vivahealthsolutions.com in June 2016. You take orders on this website for several of your products, including your Eyestonia, Ginkgo Biloba 60mg, Golden Omega-3 Max, Indole-3-Carbinol 200mg, Liveria, L-Lysine 1000mg, and ProsTac Softgel. FDA has also reviewed your promotional material (distributed at the 2016 Natural Products Expo West trade show on March 9-13, 2016), which includes claims about your Eyestonia, Liveria, and Ginkgo Biloba products. The claims on your website and promotional material establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims observed on your website that provide evidence your products are intended for use as drugs include the following:
 
On the webpage titled “Eyestonia”:
On the webpage titled “Golden Omega-3 Max”:
On the webpage titled “Indole-3-Carbinol 200mg”:
On the webpage titled “L-Lysine 1000 mg”:
On the webpage titled “ProsTac Softgel”:
Your Eyestonia, Golden Omega-3 Max, Indole-3-Carbinol 200mg, L-Lysine 1000mg, and ProsTac Softgel products are not generally recognized as safe and effective for the conditions prescribed, recommended, or suggested in the labeling thereof and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 335(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
Furthermore, claims made in your promotional material distributed at the 2016 Natural Products Expo West trade show that was held on March 9-13, 2016, at the Anaheim Convention Center provide evidence that your products are intended for use as drugs:
 
On the “Eyestonia” literature:
On the “Liveria” literature:
On the “Ginkgo Biloba” literature:
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 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 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your Eyestonia, Ginkgo Biloba, Golden Omega-3 Max, and Liveria 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. Furthermore, your Indole-3-Carbinol 200mg, L-Lysine 1000mg, and ProsTac Softgel products are intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves 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 Eyestonia, Ginkgo Biloba 60mg, Golden Omega-3 Max, Indole-3-Carbinol 200mg, Liveria, L-Lysine 1000mg, and ProsTac Softgel are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
The above violations are not meant to be an all-inclusive list of violations in connection with your products or their labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations. 

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. 

Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. If you have any questions about the contents of this letter, please contact Ms. Arnold at 425-302-0437.
 
Sincerely,
/S/
Miriam R. Burbach
District Director

cc:      Washington State Department of Agriculture
            Food Safety Program
            P.O. Box 42560         
            Olympia, Washington 98504-2560
 

This page was posted on March 29, 2019.

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