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WARNING LETTER

Supersmart USA, LLC MARCS-CMS 706566 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Alexandre Serra
Recipient Title
Mr. Benjamin Serra
Supersmart USA, LLC

66 W Flagler St Rm 918
Miami, FL 33130
United States

contact@supersmart.com
Issuing Office:
Human Foods Program

United States

January 21, 2026

WARNING LETTER

CMS# 706566

Dear Ms. and Mr. Serra:

The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.supersmart.com in October 2025 and has determined that you take orders there for your products Berberine, Aminoguanidine HCL 75mg, Berberine Max Bioactivity, Glucofit, Gymnema Sylvestre, Organic Moringa, Bromelai, Diosmin Plus, Super DHA, Tart Cherry Extract, and Celadrin®. 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 the FDA’s home page at http://www.fda.gov

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.

Unapproved New Drugs

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

Berberine

  • “Can exert anti-inflammatory, hypoglycaemic, hypotensive and hypolipidemic effects”

Aminoguanidine HCL 75mg

  • “[O]ften lowers blood glucose levels”

Berberine Max Bioactivity

  • “Ultra-bioactive berberine supplement: blood sugar, LDL...”
  • “Enhanced natural berberine supplement (obtained from the root of Berberis aristata), 10 x more bioavailable than standard berberine, with multiple benefits for blood sugar and cholesterol”
  • “Helps regulate blood sugar …”

Glucofit
• “Helps to control blood glucose levels”

Gymnema Sylvestre

  • “Gymnema sylvestre supplement for regulating blood sugar levels”

Organic Moringa

  • “Helps lower blood glucose and cholesterol levels”
  • “Helps reduce inflammation in the body”

Bromelain

  • “Has anti-inflammatory properties”

Diosmin Plus

  • “Helps restore vein function and optimal circulation”
  • “Helps reduce symptoms of venous insufficiency and haemorrhoids [sic]”

Super DHA

  • “Super DHA is a fish oil-based supplement for preventing cardiovascular problems”
  • “Reduces certain risk factors for cardiovascular disease and lowers the risk of recurrent heart attacks”
  • “Beneficial for the prevention of coronary disease and the treatment of depression”

Tart Cherry Extract

  • “Protects against…. neurodegenerative processes.”
  • “Effective anti-inflammatory to help reduce joint and bone pain.”

Celadrin

  • “Celadrin Supplement – Anti-Inflammatory Formula for Joint Pain Relief.”
  • “Celadrin® is an anti-inflammatory complex of esterified carbon fatty acids.”
  • “Designed to reduce joint pain and inflammation.”
  • “May relieve the inflammatory pain associated with osteoarthritis, rheumatoid arthritis, and tendonitis.”

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.

Misbranded Drugs

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 Super DHA product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your Super DHA product fails to bear adequate directions for its intended use, and therefore is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

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 addressed to Dr. Aaron Dotson, Compliance Officer, 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-DietarySupplement@fda.hhs.gov. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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