Mericon Industries, Inc.

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 8819 N Pioneer Rd, Peoria, IL, from August 12 through 21, 2024. Based on inspectional findings and review of product labels collected during the inspections, as well as review of your website, www.mericonindustries.com, 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 August 21, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated September 5, 2024, and we address your response below.

FDA reviewed your website at the Internet address www.mericonindustries.com in February, 2025, and has determined that you take orders there for the products Florical 100 capsules, Florical 500 capsules, and Meribin 120 capsules. 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 on your website www.mericonindustries.com that provide evidence that your products are intended for use as drugs include:

Florical 100 Capsules“Prevention and remediation of osteoporosis.”

Florical 500 Capsules“Prevention and remediation of osteoporosis.”

Your 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.

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 products Florical 100 Capsules and Florical 500 Capsules 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, Florical 100 Capsules and Florical 500 Capsules 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)].

The inspection of your facility on August 12 through 21, 2024, 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 dietary supplements 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 and/or misbranded drugs, your Florical 100 capsules, Florical 500 capsules, and Meribin 120 capsules are also adulterated dietary supplements 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 the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to 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 have not established identity specifications for your finished Florical and Meribin products. The identification test described in your batch records for these products are not adequate because they only include visual examination. Visual examination of the encapsulated powder is not be an appropriate identity test due to decreased reliability in confirming the identity of the product, potentially resulting in misidentification.

In your response to the FDA Form 483, you did not provide finished product specifications. You also stated that, due to increased costs, it is difficult to accommodate private laboratory testing of your finished dietary supplement products. As required by 21 CFR 111.75(c), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement. To date, you have not submitted any evidence of corrective action for this violation.

2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, when our investigator requested your written procedures for quality control operations, you were not able to provide any written procedures for quality control operations that are used to ensure the quality of the dietary supplements. On 05/28/2024, you manufactured Florical Lot#240528A and distributed the finished product on 08/08/2024.

In your response to the FDA Form 483, you stated that you have quality controls in the form of a manual of Standard Operating Procedures. You did not provide any documentation to demonstrate that you have established and follow written procedures for the responsibilities of the quality control operations. To date, you have not submitted any evidence of corrective action.

3. Your batch production records failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your batch production records for the Florical and Meribin dietary supplement products that you manufacture failed to include:

The identity of the equipment and processing lines used in producing the batch (21 CFR 111.260(b));

Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) (21 CFR 111.260(i));

Documentation at the time of performance that quality control personnel reviewed the batch production record (21 CFR 111.260(l)(1)).

In your response to the FDA Form 483, you stated that you plan to create an SOP to address the batch production record deficiencies. To date, you have not submitted any evidence of corrective action.

In addition, we reviewed your product labels collected during the inspection and have determined the Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules products you manufacture are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. Thus, in addition to being unapproved new drugs and misbranded drugs, your Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules are also misbranded dietary supplements under section 403 of the Act [21 U.S.C. 343].] Specifically, we identified the following:

1. Your Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules, dietary supplement products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36 and 21 CFR 101.9, and 21 CFR 101.4. For example, the calculated % Daily Value for all (b)(2)-dietary ingredients must be the quantitative amount by weight per serving divided by the RDI for each respective nutrient established in 21 CFR 101.9(c)(8)(iv), and expressed to the nearest whole percent in accordance with 21 CFR 101.36(b)(2)(C).

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.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these 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 Rebecca Allen, Compliance Officer, via email at HFPOCE-DietarySupplements@fda.hhs.gov. Please reference CMS #692733 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCEDietarySupplements@fda.hhs.gov.