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WARNING LETTER

Nature’s Elements, Inc. MARCS-CMS 719302 —

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 untreated can lead to sexual dysfunction.”
  • “Taking saw palmetto and beta-sitosterol [ingredients in DHT Blocker] together can help signs of alopecia”
  • “Saw Palmetto [ingredient in DHT Blocker] inhibits the production of DHT a form of testosterone that contributes to hair loss and prostate problems.”

Cordyceps product page https://natureselements.net/all-products/cordyceps

  • “Cordyceps… It is also an ingredient in soups and other foods used traditionally in Chinese medicine for helping sick patients recover from illness.”

Your He Shou Wu, Advanced He Shou Wu, Schizandra Berry extract, DHT Blocker, and Cordyceps 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) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, 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 that the drug is safe and effective.

Misbranded Drug

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 Schizandra Berry extract and DHT Blocker products are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention 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, Schizandra Berry extract and DHT Blocker 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 Dietary Supplements

The inspection of your facility on October 14-16, 2025 identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the He Shou Wu, DHT Blocker, Cordyceps, Maitake Mushroom, and D-Aspartic Acid (Monster T) products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Thus, in addition to being unapproved new drugs, your He Shou Wu and Cordyceps products are also adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)], and in addition to being an unapproved new drug and misbranded drug, your DHT Blocker product is also an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].

Your significant violations of the CGMP requirements are as follows:

1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to the adulteration of, the finished batch of the dietary supplement, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you did not establish product specifications to ensure the identity, purity, strength, and composition of your He Shou Wu, DHT Blocker, Cordyceps, or Maitake Mushroom dietary supplements.

In addition to establishing these specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 21 CFR 111.75.

We have reviewed your November 5, 2025 response to the form FDA 483 which includes documents described by you as finished product specifications for your He Shou Wu, DHT Blocker, Cordyceps, and Maitake Mushroom dietary supplements. However, these documents do not demonstrate that you have established the required specifications that will ensure the identity, purity, strength, and composition of the dietary supplements. For example, these documents do not establish strength specifications for each ingredient present in the products or purity. Additionally, your product specifications for He Shou Wu, DHT Blocker, Cordyceps, and Maitake Mushroom reference PPC-FTIR (Proper Process Control and Fourier-transform infrared spectroscopy) as the method of analysis for identifying product ingredients. FTIR lacks the specificity to identify the ingredients in multi-ingredient supplement products or distinguish between products with similar chemical structures.

2. You failed to establish specifications that provide sufficient assurance that the product you receive from a supplier for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, you did not establish these required specifications for He Shou Wu, DHT Blocker, and D-Aspartic Acid (Monster T) products.

In addition to establishing these specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.75(e).

We have reviewed your November 5, 2025 response, which includes documents described by you as finished product specifications for He Shou Wu, DHT Blocker, and D-Aspartic Acid (Monster T) products, as well as a written procedure for Component Receipt and Distribution, SOP 03.002, dated 11/6/2025. Your response also includes a Component Disposition Form for the receipt of bulk D-Aspartic Acid Plus Tablet (Monster T) Item # NE-009. The documents provided do not ensure you have determined the specifications required by 21 CFR 111.70(f) have been met. For example, you provided a finished product specification for D-Aspartic Acid (Monster T) that lists product code “NE-04”; however, the Component Disposition Form for D-Aspartic Acid (Monster T) included with your response lists the item number as “NE-009.” You have not provided a finished product specification for D-Aspartic Acid (Monster T) with item number or product code “NE-009.” Further, your Component Disposition Form does not document the lot number of the material received for traceability. We are unable to evaluate your corrective action without having complete information, such as specifications and receiving records for a specific lot or item number of product received from your supplier.

3. You failed to prepare a master manufacturing record for each unique formulation of a dietary supplement that you manufacture, and for each batch size of a dietary supplement that you manufacture, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection, you stated (b)(4).

We have reviewed your November 5, 2025 response to the form FDA 483. In your response, you provided a “Master Packaging Record” for D-Aspartic Acid (Monster T); however, the Master Packaging Record you provided did not include the following elements of a master manufacturing record required by 21 CFR 111.210:

  • Strength and batch size of the dietary supplement [21 CFR 111.210(a)];
  • Statement of theoretical yield [21 CFR 111.210(f)];
  • Description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)];
  • Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)]; and
  • Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(3)].

In addition, your November 5, 2025 response did not include master manufacturing records for your He Shou Wu and DHT Blocker products. As noted above, you must prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a).

4. You failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, you did not prepare a batch production record for any of your finished dietary supplement products, including He Shou Wu, DHT Blocker, and D-Aspartic Acid (Monster T). During the inspection, you informed the investigator that you have not established these records.

We have reviewed your November 5, 2025 response to the form FDA 483. Your response attached a completed “Packaging Record” for D-Aspartic Acid (Monster T), lot #(b)(4), which you included as an example of the records that you state you will now complete during your operations. However, the Packaging Record included with your response did not include the following elements of a batch production record required by 21 CFR 111.260:

  • Identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
  • The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
  • Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g), as required by 21 CFR 111.260(i);
  • Quantity of packaging used [21 CFR 111.260(k)(1)]; and
  • Documentation, at the time of performance, of packaging and labeling operations, including the results of any tests or examinations conducted on packaged and labeled dietary supplements, or a cross-reference to the physical location of such results, as required by 21 CFR 111.260(k)(3).

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also have the following comment:

  • The temperature limits ((b)(4) degrees Fahrenheit) stated in your Holding and Distribution procedure included with your November 5, 2025 response to the Form FDA 483 are inconsistent with the storage requirements (59-86 degrees Fahrenheit) listed on the He Shou Wu, DHT Blocker, and D-Aspartic Acid (Monster T) product labels collected during the inspection.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to the Dietary Supplements Enforcement Branch, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #719302 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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