Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/uustar-corporation-dba-daily-vita-llc-570337-03122019
Timestamp: 2020-07-09 15:55:21
Document Index: 371039880

Matched Legal Cases: ['§ 321', '§ 321', '§ 331', '§ 352', '§ 331', 'art 180', 'art 180', '§ 342', '§ 379', '§ 379']

Uustar Corporation dba Daily Vita, LLC - 570337 - 03/12/2019 | FDA
Uustar Corporation dba Daily Vita, LLC - 570337 - 03/12/2019
Uustar Corporation dba Daily Vita, LLC MARCS-CMS 570337 — March 12, 2019
Yanqing “Michael” Li
Uustar Corporation dba Daily Vita, LLC
1013 Investment Blvd.
NEXT DAY-SIGNATURE REQUIRED
Yanqing “Michael” Li, Owner
Chang Su, Owner
Reference: CMS Case #570337
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.
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)].
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:
Level Detected (ppm)
40 CFR Part 180 Reference
Hexachlorobenzene (Woho Premium Select American Ginseng)
No listing; not registered for use in the U.S.
Pentachlorobenzene (Sample number #1050648) (Woho Premium Select American Ginseng)
Pentachloronitrobenzene (PCNB) (Quintozene) (Woho Premium Select American Ginseng)
Procymidone (Woho Premium Select American Ginseng)
Tecnazene (Woho Premium Select American Ginseng)
No listing; not registered for use in U.S.
Chlorpyrifos (Woho Premium Select American Ginseng)
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.
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.
(Georgia-North Carolina-South Carolina)