2026-04-07 FDA Warning Letter: Nature’s Elements, Inc. Cited for CGMP/Dietary Supplement/Adulterated/Misbranded
Letter issued · posted to fda.gov .
Subject as published: CGMP/Dietary Supplement/Adulterated/Misbranded
TL;DR
In short: FDA issued a Warning Letter to Nature’s Elements, Inc. on 2026-04-07 citing: CGMP/Dietary Supplement/Adulterated/Misbranded. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natures-elements-inc-719302-04072026
Argus analysis
Nature’s Elements, Inc. (MARCS-CMS 719302) received an FDA Warning Letter dated April 7, 2026 from the Human Foods Program. The letter cites: CGMP/Dietary Supplement/Adulterated/Misbranded. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 5, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Nature’s Elements, Inc. MARCS-CMS 719302 — April 07, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Recipient: Recipient Name Richard Zul Recipient Title President Nature’s Elements, Inc. 1556 Ocean Ave Ste 11 Bohemia , NY 11716 United States info@natureselements.net Issuing Office: Human Foods Program United States April 7, 2026 WARNING LETTER CMS #719302 Dear Mr. Zul: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1556 Ocean Ave Ste 11, Bohemia, NY 11716 on October 14-16, 2025. Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website www.natureselements.net, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov. At the conclusion of the inspection on October 16, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated November 5, 2025, and we address your response below. Unapproved New Drugs FDA reviewed your website at the Internet address www.natureselements.net in October-December 2025 and has determined that you take orders there for the products He Shou Wu, Advanced He Shou Wu, Schizandra Berry extract, DHT Blocker, and Cordyceps. The claims on your website establish that the 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 that provide evidence that your products are intended for use as drugs include: He Shou Wu product page https://natureselements.net/all-products/he-shou-wu “Shou Wu is used to reduce cholesterol in part to its lecithin content.” Advanced Shou Wu product page https://natureselements.net/all-products/advanced-shou-wu “Shou Wu is used to reduce cholesterol in part to its lecithin content.” Schizandra Berry extract product page https://natureselements.net/all-products/schizandra-berry “Schizandra has been found to be protective against indigestion and numerous gastrointestinal problems.” “It is beneficial to health issues that are related to stress and has a positive effect on those with physical and emotional depression.” “Schizandra has also been known to lower blood pressure…” DHT Blocker product page https://natureselements.net/all-products/dht-blocker “Key benefits: Blocks DHT That Causes Hair Loss and Prostate Problems” “Extra DHT levels can cause prostate problems in men like enlarged prostate and BHP [sic] [Benign prostatic hyperplasia] problems which left untr…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Nature’s Elements, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Nature’s Elements, Inc. as of 2026-05-05. Argus ingests new FDA enforcement records daily.
- What FDA violations was Nature’s Elements, Inc. cited for?
- The FDA Warning Letter to Nature’s Elements, Inc. (issuing office: Human Foods Program) cites: CGMP/Dietary Supplement/Adulterated/Misbranded. Classification: CGMP — Current Good Manufacturing Practice.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-04-07 FDA Warning Letter: Nature’s Elements, Inc. Cited for CGMP/Dietary Supplement/Adulterated/Misbranded. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-nature-s-elements-inc-2026-04-07-cgmp
"2026-04-07 FDA Warning Letter: Nature’s Elements, Inc. Cited for CGMP/Dietary Supplement/Adulterated/Misbranded." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-nature-s-elements-inc-2026-04-07-cgmp.
Argus HQ Research. "2026-04-07 FDA Warning Letter: Nature’s Elements, Inc. Cited for CGMP/Dietary Supplement/Adulterated/Misbranded." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-nature-s-elements-inc-2026-04-07-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_nature_s_elements_inc_2026_04_07_cgmp_2026,
title = {2026-04-07 FDA Warning Letter: Nature’s Elements, Inc. Cited for CGMP/Dietary Supplement/Adulterated/Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-nature-s-elements-inc-2026-04-07-cgmp},
note = {Accessed: July 13, 2026}
}