Source: https://www.casewatch.net/fdawarning/prod/2016/hsus.shtml
Timestamp: 2020-02-20 05:08:20
Document Index: 279055595

Matched Legal Cases: ['§ 321', '§ 321', '§ 331', '§ 352', '§ 353', '§ 352', '§ 331']

FDA Warning Letter to Hsu's Ginseng Enterprises, Inc 7/22/16
Refer to MIN 16 - 14
This is to advise you that in April 2016 the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.hsuginseng.com and www.roottohealth.com (which redirects to www.hsuginseng.com). You take orders on these websites for several of your products, including your ALASKA Fish Oil, Cultivated Pearl Medium Deluxe Pack, Ejia Black Soy Bean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Ocean Luck Premium Abalone, Spirulina Plus B6 & B12, and White Bird’s Nest. Also, FDA reviewed your promotional material “Root to Health Wellness Center” (distributed at the 2016 Natural Products Expo West trade show on March 9-13, 2016) that includes a phone number, fax number, email address, and website address for ordering your products. In addition, FDA reviewed your Facebook webpage in May 2016 which includes claims about American ginseng which you market as Cultivated Pearl Medium Deluxe Pack. The claims on your websites, promotional material, and Facebook page 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 www.hsuginseng.com website that provide evidence your products are intended for use as drugs include the following:
On the webpage titled “Ejia Black Soy Bean Powder”:
“Help prevent diabetes”
“Improve anemia”
“Reduce the risk of cancer and heart disease”
“Black soya bean may have anti-fungi, anti-viral activities”
“Remove anemia”
On the webpage titled “Ejia Lappa Tea Powder”:
“Lowering cholesterol”
“Preventing colorectal cancer”
On the webpage titled “Ejia Mangosteen Powder”:
“Anti-allergenic”
“Anti-arthritic”
“Anti-atherosclerotic”
“Anti-cataract”
“Antidepressant"
“Antifungal”
On the webpage titled “Hokkaido Dried Seaweed”:
“[R]educe blood pressure”
On the webpage titled “Ocean Luck Premium Abalone”:
“[P]revent and treat debilitating health conditions including arthritis”
On the webpage titled “White Bird’s Nest”:
“[A]nti-cancer”
We also note that FDA collected promotional material (“Root to Health Wellness Center”) for your products at the 2016 Natural Products Expo West trade show that was held on March 9-13, 2016, at the Anaheim Convention Center. This promotional material instructs that your products can be ordered at roottohealth.com which redirects to www.hsuginseng.com. The promotional material also provides a phone number, fax number, and email address for ordering your products. Claims included in the promotional literature provide evidence that your products are intended for use as drugs:
Spirulina Plus B6 & B12: “Can lower LDL cholesterol…effective in fighting cancer cells; may reduce blood pressure”
ALASKA Fish Oil: “[C]an prevent heart disease and stroke, as well as reducing the effects of glaucoma and Age-Induced Macular Degeneration (AMD)”
K BEST Vitamin D: “[K]nown to help prevent Type 1 diabetes, as well as breast, prostate, colon, ovarian, esophageal, and lymphatic system cancers. Reduces the risk of heart disease, rheumatoid arthritis, as well as multiple sclerosis.”
Nattozimes: “[R]educing the effects of clotting which in turn may prevent heart failure and strokes.”
Your ALASKA Fish Oil, Ejia Black Soy Bean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Ocean Luck Premium Abalone, Spirulina Plus B6 & B12, and White Bird’s Nest 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) and 355(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 on your Facebook page, www.facebook.com/hsuge provide additional evidence that your products are intended for use as drugs:
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 by 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 ALASKA Fish Oil, Cultivated Pearl Medium Deluxe Pack, Ejia Black Soy Bean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Spirulina Plus B6 & B12, and White Bird’s Nest 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 ALASKA Fish Oil, Cultivated Pearl Medium Deluxe Pack, Ejia Black Soy Bean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Spirulina Plus B6 & B12, and White Bird’s Nest fail to bear adequate directions for their intended use and are, therefore, 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).
Please notify this office in writing within 15 working days from your receipt of this letter of 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. Your response in writing should be addressed to CDR Christopher van Twuyver, Director, Compliance Branch, Minneapolis District, at the address on the letterhead. If you have any questions about the contents of this letter, please contact CDR van Twuyver at (612) 758-7112.
This page was posted on August 18, 2016.