Inspections, Compliance, Enforcement, and Criminal Investigations

Hsu's Ginseng Enterprises, Inc Response Letter

HSU'S GINSENG ENTERPRISES, INC.

EXPORTER - BROKER - GROWER OF AMERICAN AND KOREAN GINSENG - WILD & CULTIVATED GINSENG ROOTS, GOLDENSEAL AND OTHER HERBS - SEAFOOD IMPORTER

T6819 COUNTY ROAD W
P.O. BOX 509
Wausau, WI 54402-0509
715-675-2325
800-826-1577
800-388-3818
Fax:715-675-3175
info@hsuginseng.com

CDR Christopher van Twyver
Director, Compliance Branch
Minneapolis District Office
U.S. Food and Drug Administration
250 Marquette Avenue. Suite 600
Minneapolis, MN 55401


Re: Hsu's Ginseng Enterprises, incorporated
Response to Warning Letter (Refer to Min 16-14)

Dear Christopher van Twyver

On July 25, 2016 we received a warning letter dated July 22, 2016 from the U.S. Food and Drug Administration (further known as the "FDA") which concluded that there were violating claims stated on the internet, social media and incorporated into marketing/promotional materials by Hsu's Ginseng Enterprises, Incorporated (further known as "Hsu's") located in Wausau Wisconsin. We understand according to the claims made regarding our website, printed promotional materials and Hsu's Facebook page these allocated the products as "new drugs" under section 201(g)(1)(B) of the Federal Food Drug and Cosmetic Act. We recognize and take seriously the significance of the observations by the FDA and are committed to taking all actions necessary now, and in the future, to ensure that all items are in compliance with FDA requirements.

We wish to respond to the issues raised in the warning letter, in order to provide clear information on corrective actions we have taken according to the applicable directions of section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. section 321 (g)(1)(B). We would like to politely request that this response to the warning letter be posted on the FDA website. If you are in need of this response in electronic format please contact us and we will provide it for you. Thank you.

OBSERVANCE 1: Claims observed on the www.hsuginseng.com website provide evidence our products are intended for use as drugs

ISSUE 1: "Your ALASKA Fish Oil, Ejia Black Soybean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Ocean Luck Premium Abalone, Spirulina B6 & B12, and White Bird's Nest products are not generally recognized as safe and effective for the prescribed, recommended, or suggested in the labeling therefore these products are considered "new drugs".

RESPONSE 1: Due to the fact that many of our products' descriptions have been translated from foreign languages as the products are being sourced from other countries, some of the translations and implications were incorrect and were not reviewed for correct English context. Steps have been taken to create, edit, integrate and approve product descriptions translated into English prior to publishing to the www.hsuginseng.com website. Some applicable uses, directions and claims have been edited or removed. Some of the noted products have been removed from the www.hsuginseng.com website due to upcoming discontinuation.

Accordingly, the appropriate staff has been versed and will be trained to realize and amend any Hsu's product descriptions now, and in the future, as necessary per the directions of the FDA .

Please refer to the enclosed FDA APPENDIX 1 for evidence regarding the appropriate changes/edits to this observance or reference the Hsu's website www.hsuginseng.com.

OBSERVANCE 2: Claims included in promotional literature provide evidence that our products are intended for use as drugs.

ISSUE 2: "FDA collected promotional material ("Root To Health Wellness Center") for your products at the 2016 Natural Products West Expo" that was held March 9-13, 2016 at the Anaheim Convention Center. This promotional literature directs you to www.roottohealth.com which redirects you to www.hsuginseng.com." It continues as "Claims included in the promotional literature provide evidence that your products are intended for use as drug:" The products referenced are Spirulina B6 & B12, ALASKA Fish Oil , K BEST Vitamin D and Nattozimes

RESPONSE 2: After review, it was determined that some products referred to in this promotional literature are also referenced with ISSUE 1. The edits made to these product descriptions are in relation to RESPONSE 1. Some modifications were made in the edited text due to allocated space for each item. The Spirulina B6 & B12 product was removed from the literature clue to discontinuation. This promotional literature will be discontinued by September 1, 2016 due to the dating of retail prices.

Accordingly, the appropriate staff has been versed and will be trained to monitor and recognize these claims prior to any future design or printing of promotional literature, per the directions of FDA regulations.

Please refer to the enclosed FDA APPENDIX 2 for evidence showing the edits and changes made to the "Root To Health Wellness Center" promotional literature.

OBSERVANCE 3: Claims made on your Facebook page, www.facebook.com/hsuge provide additional evidence that our products are intended for use as drugs:

ISSUE 3: "On January 14, 2016, your company shared a photo which states: American ginseng ... can be used ... conditions like high blood pressure ... or ulcers."

RESPONSE 3: Due to this "Like" referencing a second party's post it has been removed from the Hsu's facebook page.

Accordingly the appropriate staff has been versed and will be trained to monitor and recognize these claims prior to any future posting on our social media platforms, per the directions of FDA regulations.

Please refer to the enclosed FDA APPENDIX 3 for evidence supporting the removal of the referenced post on the Hsu's facebook page or reference our Facebook page - www.facebook.com/hsuge.

In conclusion, Hsu's Ginseng Enterprises, Incorporated, respects the observations and issues the U.S. Food and Drug Administration have presented. Through the guidance provided by the FDA, we feel appropriate changes have been made.

If there are any further questions or concerns please let us know and we will work to gather answers immediately. Thank you for bringing attention to these matters and we look forward to working with the FDA in the future.

Sincerely.
/s/
Scott Theiss
Facility and Quality Assurance Manager
Hsu's Ginseng Enterprises. Incorporated

Enclosure: FDA Appendix, 3 pages

cc: Will Hsu, Vice President of Operations
Hsu 's Ginseng Enterprises, Incorporated

cc: Tony Guo, Vice President of R&D
Hsu 's Ginseng Enterprises, Incorporated

Page Last Updated: 12/16/2016
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