Meta Labs Pharmaceuticals, LLC

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1009 Mansell Rd Ste J, Roswell, GA 30076 from December 8 through December 18, 2025. Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website at www.metalabsinc.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 December 18, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). To date, we have not received a response from your firm.

FDA reviewed your website at the Internet address www.metalabsinc.com in April of 2026 and has determined that you take orders there for the products Yacon Root Extract, Nattokinase Max, Viral Immune Booster, Arthritis Bursitis Rheumatism, and Respiratory Response. FDA also reviewed product labels for your Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, Arthritis Bursitis Rheumatism, and Respiratory Response following the inspection of your facility from December 8 to December 18, 2025. The claims on your website and product labels 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 that provide evidence that your products are intended for use as drugs include:

From the label of your Diabetic Advantage:

“Diabetic Advantage”

“Supports: Glucose management . . . …..“Anti-Inflammatory and Pain”

From the website from which you sell your Yacon Root Extract (www.metalabsinc.com):

“Yacon has a generally high percentage of fructooligosaccharides (FOS) and inulin . . .. The association of FOS and inulin provides a protective effect against colitis. . . . In addition, FOS has important beneficial physiological effects, such as reducing the risk of colon and rectal cancer, reducing cholesterol, triglycerides, and phospholipids in the blood, promotes a better immune response that increases resistance to infections an allergies, improves calcium and magnesium absorption, magnesium uptake leads to a reduced risk of colorectal cancer. . . . The literature also provides benefits for arthritis problems.”

“[Y]acon reduces glucose concentration in diabetics.”

From the label of your Nattokinase Max:

“May Lower Blood Pressure”

From the website from which you sell Nattokinase Max (www.metalabsinc.com):

“Nattokinase benefits: thins the blood, . . . disinfects and has anti-parasitic effects; normalizes blood pressure; reduces cholesterol concentration . . .”

“The use of the appropriate drug is: prevention of thrombophlebitis; reduced viscosity of lymph; eliminating the problem of increased blood coagulation; reduced risk of atherosclerosis; prevention of coronary heart disease; reduced likelihood of stroke and heart attack . . . impeding salt deposition and osteoporosis . . . prevention of intestinal infections. . . . The nutritional supplement of nattokinase can be attributed both for medicinal purposes and for prevention. It can replace some of the drugs. For example, it is a safer alternative to asperin.”

From the website from which you sell Viral Immune Booster (www.metalabsinc.com):

“Antiviral Supplement: Since ancient time, herbs have been used as natural treatments and remedies for various illnesses to include viral infections. . . . [M]any herbs help fight viruses . . … Our decision to use several of the herbs in our formula was based on giving you the best chance of protection against various viral infections. 1. Oregano: Oregano . . . is known for its impressive medicinal qualities to include anti-viral properties . . .. 2. Sage . . . has long been used in traditional medicine to treat viral infections. . . . 5. Garlic: A popular remedy for a wide array of conditions, including viral infections. Test-tube studies note that garlic may have antiviral activity against influenza A and B,HIV, HSV-1, viral pneumonia, and rhinovirus, which causes the common cold. . . . 10. Astragalus . . . combats herpes viruses, hepatitis C, and avian influenza H9 virus.”

The claims made on the website from which you sell Arthritis Bursitis Rheumatism (www.metalabsinc.com):

Name of product is a claim “ Arthritis Bursitis Rheumatism” “arthritis, Buritis, Tendonitis, Joint Pain, Sport Injury, Healps Reduce Sciatic Nerve Pain, Post Surgery Pain:

From the website from which you sell Respiratory Response (www.metalabsinc.com):

“Respiratory Response was developed to fight . . . shortness of breath and congestion from asthma, exercise induced asthma, emphysema, allergies, bronchitis, colds, and flu”

“Active Ingredients: Tylophora: Traditionally used to treat airway constriction due to asthma and other respiratory conditions. . . . Buplereum: . . . boosting anti-inflammatory defense. . . . Long Pepper: …used for treating coughs, colds, fevers, and a variety of stomach ailments. Ginger: Uses include treating upper respiratory tract infections, cough, and bronchitis.”

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 Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, and Respiratory Response 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, Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, and Respiratory Response 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 from December 8 through December 18, 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). In addition to being unapproved new drugs and misbranded drugs, these violations cause the Diabetic Advantage and Respiratory Response 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.

Your significant violations of the CGMP requirements are as follows:

1. You failed to establish product specifications for the identity, purity, strength, composition of the finished batch of dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you have not established finished product specifications including identity, purity, strength, and composition, and limits on contamination for your finished dietary supplements Diabetic Advantage and Respiratory Response.

In addition to establishing the required finished product specifications, you must determine whether the established specifications are met, in accordance with 21 CFR 111.75(c), using appropriate scientifically valid methods.

2. You failed to establish, for each component that you use in the manufacture of a dietary supplement, identity specifications for each component; component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met; and limits on the types of contamination that may adulterated or may lead to the adulteration of the finished batch of dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b). Specifically, you stated that you have not created individual dietary ingredient specifications for all dietary ingredients used in your finished dietary supplement products.

In addition to establishing the required component specifications, before using each component you must determine whether the specifications established are met, as required by 21 CFR 111.75(a). Additionally, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition FDA under 21 CFR 111.75(a)(1)(ii) and FDA grants the petition. Furthermore, to rely on the supplier’s certificate of analysis for components other than dietary ingredients you must meet the requirements of 21 CFR 111.75(a)(2)(ii).

3. You failed to establish master manufacturing records (MMRs) that identify specifications for the 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 MMR, as required by 21 CFR 111.205(b)(1) and in accordance with 21 CFR 111.210. Specifically, your MMRs for Diabetic Advantage Lot: (b)(4) and Respiratory Response 590 MG (Lot: (b)(4)) fail to include the following required information:

The identity and weight or measure of each dietary ingredients that will be declared on the Supplement Facts label [21 CFR 111.210(d)];

A statement of theoretical yield of a manufactured dietary supplement expected at at the mixing, encapsulating, and packaging stages of the manufacturing process [21 CFR 111.210(f)];

A description of packaging [21 CFR 111.210(g)];

Specifications for each point, step, or stage 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 manufacturing record [21 CFR 111.210(h)(1)];

Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];

Specific actions necessary to perform and verify points, steps, or stages in the (b)(4) 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)];

Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)]

4. Your batch production record (BPR) failed to include complete information relating to the production and control of each dietary supplement batch manufactured, as required by 21 CFR 111.255(b) and in accordance with 21 CFR 111.260. Specifically, your BPRs for Diabetic Advantage Lot: (b)(4) and Respiratory Response 590 MG (Lot: (b)(4)) failed to include the following required information:

The 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)];

A statement of the actual yield and a statement of the percentage of theoretical yield at (b)(4) steps [21 CFR 111.260(f)];

Documentation at the time of performance that quality control personnel’s review of any monitoring operation required under 21 CFR part 111, subpart E [21 CFR 111.260(l)(1)(i)]. Specifically, your quality unit has not reviewed and approved your Diabetic Advantage 720mg Lot (b)(4) “ENCAPSULATED RING WEIGHTS” record;

Documentation, at the time of performance, of packaging and labeling operations, including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)]. Specifically, your batch production records did not include the quantity of labels used for the Diabetic Advantage Lot (b)(4) and Respiratory Response Lot (b)(4) products.

5. You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel for the use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d). Specifically, during the inspection, you stated that your firm's in-house laboratory and Quality Assurance (QA) staff evaluate the density and color of each finished product by comparing it against the most recently manufactured batch. Relying on a different comparison batch each time undermines the ability to detect deviations in the manufacturing process and may obscure deterioration in product quality over time.

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 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 Lauren.Crivellone@fda.hhs.gov 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 #725130 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.