WARNING LETTER

Uustar Corporation dba Daily Vita, LLC MARCS-CMS 570337 — March 12, 2019

Product:: Dietary Supplements
Drugs
Food & Beverages

Recipient:: Recipient Name

Yanqing “Michael” Li; Recipient Title

Owner; Uustar Corporation dba Daily Vita, LLC; 1013 Investment Blvd.
Apex, NC 27502-1955
United States

Issuing Office:: Division of Human and Animal Food Operations East III; 60 Eight Street, NE
Atlanta, GA 30309
United States

March 12, 2019

VIA UNITED PARCEL SERVICE

NEXT DAY-SIGNATURE REQUIRED

Yanqing “Michael” Li, Owner

Chang Su, Owner

1013 Investment Blvd.

Apex, NC 27502-1955

Reference: CMS Case #570337

WARNING LETTER

Dear Mr. Li and Ms. Su:

From August 6, 2018, through August 9, 2018, the U.S. Food and Drug Administration conducted an inspection of your manufacturing facility located at 1013 Investment Blvd., Apex, NC 27502-1955. During the inspection, we also collected labeling for your WOHO Premium Select sliced American Ginseng product in 4-ounce (oz) packaging and Hsu’s Root to Health sliced American Ginseng product in 4-ounce (oz) packaging. Based on the inspectional findings, a review of the product labels collected during the inspection, and a subsequent review of your website at the Internet address http://www.woohoonatural.com March 2019, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.

Unapproved New and Misbranded Drugs

The FDA reviewed your website at the Internet address http://www.woohoonatural.com in March 2019 and has determined that you take orders there for the products WOHO Premium Select American Ginseng, Reishi King Triple Mushroom, ProstaRX-9, Joint Flex, Pure American Ginseng Capsules, and Extra Strength Lecithin. We have also reviewed the labels for your products collected during the August 2018 inspection. The claims on your product labels and website establish that these products are drugs under Section 201(g)(1)(B) of 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.

Examples of some of the claims on your product labels and website http://www.woohoonatural.com that provide evidence these products are intended for use as drugs include:

On your product labels:

WOHO Premium Select American Ginseng product label:

“Lowers blood cholesterol level”

“Protects cells from damage due to radiation and exposure to toxins”

On the webpage http://www.woohoonatural.com:

On the product page for Reishi King Triple Mushroom at http://www.woohoonatural.com/products/supplements/8840572-reishi-king-triple.html:

“Some of the health benefits of Red Reishi include lowering of high blood pressure, improvement of kidney functions…”

On the product page for ProstaRX-9 at http://www.woohoonatural.com/products/supplements/8840533-prosta-rx-9.html:

“It (saw palmetto extract, an ingredient in this product) has been used in traditional, eclectic, and alternative medicine for a variety of indications, most notably benign prostatic hyperplasia.”

“It (stinging nettle, an ingredient in this product) has been used for hundreds of years to treat painful muscles and joints, eczema, arthritis, gout, and anemia. Today, many people use it to treat urinary problems during the early stages of an enlarged prostate (called benign prostatic hyperplasia or BPH), for urinary tract infections, for hay fever (allergic rhinitis), or in compresses or creams for treating joint pain, sprains and strains, tendonitis, and insect bites…”

On the product page for Joint Flex at http://www.woohoonatural.com/products/supplements/8850585-super-strength-joint-flex.html:

“The inability for some of us to produce glucosamine or the reduced production generally associated with age may be a leading factor in the development of osteoarthritis. Studies have shown that patients who take non-steroidal anti-inflammatory drugs (NSAIDs) felt better initially, but after three to six weeks, the group on glucosamine sulfate felt better….”

“Animal studies indicate that chondroitin sulfate can promote healing of bone…”

“Boswellia has been discovered that this herb contains certain substances called boswellic acids, which are known to have anti-inflammatory properties; therefore, Boswellia is often suggested as a treatment for bursitis, osteoarthritis, rheumatoid arthritis. Research shows that this herb may also protect cartilage from damage…”

“These necessary elements support and maintain healthy joints and repair the damage that causes pain and swelling associated with arthritis. Chondroitin also acts as an anti-inflammatory compound and pain modulator without the negative side effects of non-steroidal medicines while enhancing the synthesis of cartilage and HA. Supplementing with Collagen Type II focuses on the regenerating effects for skin and connective tissue health….”

“MSM is a natural substance that gives relief from joint pain, inflammation and allergies…”

On the product page for Pure American Ginseng capsules at http://www.woohoonatural.com/products/supplements/8841100-pure-american-ginseng-caps.html:

“[R]educe neuronal death following transient cerebral ischemia. Ginseng has proven efficacious in some diseases, such as amyotrophic lateral sclerosis (ALS, motor neuron disease).”

On the product page for Extra Strength Lecithin at http://www.woohoonatural.com/products/supplements/8815180-extra-strength-lecithin.html:

“[U]seful effects in a number of neurological, psychiatric and infectious diseases and disorders.”

“Lecithin is among a number of substances derived from soybeans that are being researched for potential health benefits, including lowering the risks of cardiovascular disease (CVD) and cancer.”

Your WOHO Premium Select American Ginseng, Reishi King Triple Mushroom, ProstaRX-9, Joint Flex, Pure American Ginseng Capsules, and Extra Strength Lecithin 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)(1) of the Act [21 U.S.C. § 321(p)(1)]. 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 U.S.C §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating the drug is safe and effective.

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 WOHO Premium Select American Ginseng, Reishi King Triple Mushroom, ProstaRX-9, Pure American Ginseng Capsules, and Extra Strength Lecithin 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 these products safely for their intended purposes. Accordingly, your WOHO Premium Select American Ginseng, Reishi King Triple Mushroom, ProstaRX-9, Pure American Ginseng Capsules, and Extra Strength Lecithin 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 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)].

Adulterated Food:

Furthermore, your Hsu’s Root to Health sliced American Ginseng product in 4-ounce (oz) packaging is an adulterated food, and even if your Woho Premium Select American Ginseng product in 4-ounce (oz) packaging were not an unapproved new drug and misbranded drug, it would be an adulterated food. FDA analyzed intact samples of Woho Premium Select American Ginseng product in 4-ounce (oz) packaging (sample number #1050648) and Hsu’s Root to Health sliced American Ginseng product in 4-ounce (oz) packaging (sample number #1050649), which were collected from your firm and found to contain the pesticide chemical residues as follows:

Pesticide	Level Detected (ppm)	40 CFR Part 180 Reference
Hexachlorobenzene (Woho Premium Select American Ginseng)	0.143	No listing; not registered for use in the U.S.
Pentachlorobenzene (Sample number #1050648) (Woho Premium Select American Ginseng)	0.279	No listing; not registered for use in the U.S.
Pentachloronitrobenzene (PCNB) (Quintozene) (Woho Premium Select American Ginseng)	1.49	180.291
Procymidone (Woho Premium Select American Ginseng)	0.060	180.455
Tecnazene (Woho Premium Select American Ginseng)	0.151	No listing; not registered for use in U.S.
Chlorpyrifos (Woho Premium Select American Ginseng)	0.030	180.342
Fluopicolide (Hsu’s Root to Health sliced American Ginseng)	0.204 (orig)/0.233 (check)	0.15 ppm per 180.627

The Environmental Protection Agency established tolerances for certain pesticide chemical residues in Title 40, Code of Federal Regulations (CFR). Per 40 CFR Part 180 there are no established tolerances for Quintozene, Hexachlorobenzene, Pentachlorobenzene, Procymidone, Tecnazene, or Chlorpyrifos that would apply to ginseng. Per 40 CFR 180.627 there is an established tolerance of 0.15 ppm for fluopicolide on vegetable root, subgroup 1A; ginseng is listed as a commodity in crop group 1A; therefore, the established tolerance would apply. The level of fluopicolide reported exceeded the established tolerance.

Your Woho Premium Select American Ginseng product in 4-ounce (oz) packaging and Hsu’s Root to Health sliced American ginseng product in 4-ounce (oz) packaging are adulterated within the meaning of

Section 402(a)(2)(B) of the Act [21 U.S.C. § 342(a)(2)(B)] in that they bear and contain pesticide chemical residues that are unsafe within the meaning of Section 408(a) of the Act [21 U.S.C. 346a] because the pesticide chemical residues exceed applicable tolerance level or no tolerance levels have been established, and no exemption from the requirement of a tolerance is in effect for the pesticide chemical residues on the products at issue.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or 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, including 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/or injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. Reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31 (a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your written reply should be sent to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, NE Atlanta, GA 30309. If you have any questions, please contact Ms. King at (b)(6) or e-mail at Janice.king@fda.hhs.gov.

Sincerely,

/S/

Ingrid A. Zambrana

District Director

U.S. Food & Drug Administration

FDA Atlanta District

Office of Human and Animal Foods- Division 3 East

(Georgia-North Carolina-South Carolina)

Office of Regulatory Affairs