- J&E International Corp
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
July 22, 2016
In reply refer to Warning Letter SEA 16-16
Dr. Jason Ko, President
J & E International Corporation
1365 Stonegate Way
Ferndale, Washington 98248-7824
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”:
- “Used in herbal medicine to help slow the progression of disorders of the eye, such as diabetic and hypertensive retinopathy as well as macular degeneration.”
On the webpage titled “Golden Omega-3 Max”:
- “Lowers blood pressure in hypertensive individuals”
- “Lowers cholesterol levels”
- “Protects against cardiovascular diseases such as atherosclerosis, myocardial infarction, coronary heart disease, and arrhythmias”
- “Alleviates symptoms of depression and anxiety”
On the webpage titled “Indole-3-Carbinol 200mg”:
- “I3C . . . prevention of various cancers (prostate, lung, breast, and colon cancers).”
On the webpage titled “L-Lysine 1000 mg”:
- “Helps to reduce the recurrence of herpes simplex virus (HSV) infection (e.g. cold sores).”
On the webpage titled “ProsTac Softgel”:
- “[P]rotect against development of cancerous prostate cell lines”
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:
- “The ingredients . . . slow the progression of diabetic and hypertensive retinopathy.”
- “[S]low the progression of age-related macular degeneration, cataracts, glaucoma, and diabetic retinopathy”
- “[D]ecreased risk for any stage of AMD”
On the “Liveria” literature:
- “[R]educes liver injury caused by acetaminophen, carbon tetrachloride, radiation, iron overload, phenylhydrazine, alcohol, cold ischemia and Amanita phalloides.”
- “[T]reat various hepatic disorders, including chronic alcoholic and viral hepatitis, alcoholic cirrhosis . . . liver damage … It can be used in lowering cholesterol levels and reducing insulin resistance in type 2 diabetes mellitus”
- “Clinically effective in treatment of alcoholic cirrhosis.”
- “May provide long-term treatment reduce [sic] . . . insulin resistance (diabetic cirrhosis).”
- “May potentially effective [sic] in improving symptoms of acute hepatitis.”
- “May block both viral infection and viral production/release.”
On the “Ginkgo Biloba” literature:
- “Traditional used [sic] . . . : multiple sclerosis, caudation, tinnitus, blood pressure . . . improving ocular disorders, and sexual dysfunction.”
- “Clinical benefits: ischemia, epilepsy, peripheral nerve damage, and dementia.”
- “Clinically improves neuropsychiatric symptoms.”
- “Clinically improves cognitive function (Alzheimer’s disease, vascular or mixed dementia).”
- “Clinical benefits at a dose of 240mg/day for treatment of dementia and cognitive impairment with neuropsychiatric symptoms.”
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.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560