New Green Nutrition Inc.

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October 26, 2026

WARNING LETTER
Reference Number: 737576

To Peng Xiang Lu:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://www.newgreenusa.com, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

Additionally, FDA obtained a sample of your “Qu Feng Huo Luo Dan” product and has serious safety concerns about it. FDA confirmed through laboratory analysis that “Qu Feng Huo Luo Dan” contains dexamethasone. Dexamethasone is a steroid medication commonly used to reduce inflammation. However, it can weaken the immune system, making it harder for the body to fight infections. It also can cause high blood sugar, muscle damage and mental health problems.

FDA Review

Violations were identified and documented during a review of your website https://www.newgreenusa.com in September 2026. In addition, FDA obtained a sample of your “Qu Feng Huo Luo Dan” through this website. Based on our review, “Qu Feng Huo Luo Dan,” “Pearl Eye Drops,” “Japan Reishi Mushroom Powder,” and “Shu Jin Huo Xue Wan” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, “Qu Feng Huo Luo Dan” is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Unapproved New Drug Violations

Based on a review of your website, “Qu Feng Huo Luo Dan,” “Pearl Eye Drops,” “Japan Reishi Mushroom Powder,” and “Shu Jin Huo Xue Wan” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

Qu Feng Huo Luo Dan
On the product packaging:

• “INDICATIONS: Heal rheumatism, Sciatica, Paraplegia, Arthritis. Notalgia, Apasm [sic], Help Circulation of Blood, Strengthen Muscles and Bones.”

Pearl Eye Drops
On the webpage https://www.newgreenusa.com/products/pearl-eye-drops-10ml?_pos=1&_sid=521084768&_ss=r:

• “All natural herbal base formula with pearl ingredient,” “Lasting relief; soothing comfort,” and “Formulated to shield from red eyes and tired eyes discomfort”
  On the product packaging (translated from Chinese):
• “[N]ourishes the liver and improves eyesight; used for extreme... Fatigue syndrome and chronic diseases”

Japan Reishi Mushroom Powder
On the webpage https://www.newgreenusa.com/collections/reishi-immune-system/products/japan-reishi-mushroom-powder-100-capsules:

• “Functions: Improve the metabolism, the circulation and respiratory systems, maintain normal digestive functions, regulate endocrine functions . . . lessen fatigue and improve quality of sleep.”
• “Used in Traditional Chinese Medicine to nourish the heart and strengthen qi and blood to treat head and spleen deficiencies that manifest in insomnia, forgetfulness, fatigue, listlessness and poor appetite. Source of fungal polysaccharides with immunomodulating properties.”

Shu Jin Huo Xue Wan
On the webpage https://www.newgreenusa.com/products/shu-jiu-huo-xue-wan-200-pills?variant=32973078790253:

• “Helps blood stasis with wind-damp in the channels and collaterals characterized by internal deficiency with external excesses - joint pain, muscle aches, numbness and/or pain in the lower extremities”

“Qu Feng Huo Luo Dan,” “Pearl Eye Drops,” “Japan Reishi Mushroom Powder,” and “Shu Jin Huo Xue Wan” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranded Drug Violations

“Qu Feng Huo Luo Dan” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Qu Feng Huo Luo Dan” product does not declare that it contains dexamethasone. As previously mentioned, FDA confirmed through laboratory analysis that your “Qu Feng Huo Luo Dan” product contains dexamethasone. Consumers may purchase and use the product without knowing it contains an ingredient that may cause serious harm or interact dangerously with other medications. The failure to disclose dexamethasone in the product labeling renders your product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number “737576” in the subject line of the email.

Please note FDA posts warning letters on www.fda.gov.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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