Naturista Store LLC - 701480 - 03/26/2025

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WARNING LETTER

March 26, 2024

RE: 701480

Dear Andy Garcia:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturistastore.com/ from Dec 2024 to February 2025, and has observed that your website offered the product “ADVANCE KING”¹ for sale in the United States. In addition, FDA has obtained a sample of your “ADVANCE KING” product. As described below, this product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “ADVANCE KING” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

FDA confirmed through laboratory analysis that a sample of your “ADVANCE KING” product contains the undeclared active pharmaceutical ingredients dexamethasone, diclofenac, and methocarbamol. Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in “ADVANCE KING” may cause serious side effects when combined with other medications.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.

Information on the label and/or labeling of your “ADVANCE KING” product demonstrates that this product is marketed as a dietary supplement.² However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988 and dexamethasone, under the trade name Hexadrol, as a new drug on December 21, 1960. Given that diclofenac and dexamethasone were not marketed as dietary supplements or as food before Voltaren and Hexadrol were approved, “ADVANCE KING,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).

Moreover, we note regardless of whether your “ADVANCE KING” product is excluded from the definition of a dietary supplement, it is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for, among other things, use as an arthritis treatment.

Unapproved New Drug

Your “ADVANCE KING” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims observed on your website and from the labeling that provide evidence of the intended use of these products as drugs include, but may not be limited to the following:

On your product label:

• “Hierbas medicinales para CALMAR el DOLOR” (English translation: Herbal medicine to relieve pain)
  o “Ciática” (English translation: Sciatica)
  o “Ácido Urico” (English translation: Uric Acid)
  o “Osteoartritis” (English translation: Osteoarthritis)
  o “Arteriosclerosis” (English translation: Arteriosclerosis)
  o “Gota” (English translation: Gout)

On your product promotional labeling

• “Advance King es un suplemento totalmente natural para todos, desde atletas competitivos hasta jubilados que disfrutan de sus años dorados. Nuestra fórmula natural, puede ayudar potencialmente a fortalecer tus huesos, reducir el dolor articular, la rigidez articular y el deterioro del cartílago.” (English translation: Advance King is a totally natural supplement for everyone, from competitive athletes to retired people enjoying their golden years. Our natural formula can potentially help to strength your bones, reduce your joint pain, joint rigidity, and cartilage damage.) 
• “Fortalece y recupera la MOVILIDAD y FLEXIBILIDAD de tus articulaciones” (English translation: Strengthen and regain the mobility and flexibility in your joints)

Your “ADVANCE KING” product is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There is no FDA-approved application in effect for your “ADVANCE KING,” product. Introduction or delivery of this product into interstate commerce without an approved application violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Misbranded Drug

Your “ADVANCE KING” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “ADVANCE KING” product does not declare that the product contains dexamethasone, diclofenac, and methocarbamol. As previously mentioned, these undeclared ingredients in your “ADVANCE KING” product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose these ingredients in the product labeling renders your “ADVANCE KING” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

We also documented that your website https://naturistastore.com/ offered for sale “NatuMex Artri Ajo King,”³ “NatuMex Artri King,”⁴ “Royal Honey Sachets,”⁵ “CURCUFLEX,”⁶ “UNAVY,”⁷ “Rmary Hyaluronic Acid,”⁸ “FOREVER FOREVER,”⁹ and “Kukamonga Acido Hialuronico,”¹⁰ to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter also expresses our serious concern about the safety of these products and emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.

Conclusion

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/or injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 701480” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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1 FDA issued a warning to consumers not to use your “ADVANCE KING” product (see: https://www.fda.gov/drugs/medication-health-fraud/advance-king-may-be-harmful-due-hidden-drug-ingredients).

2 “ADVANCE KING” is labeled as dietary supplement on the product packaging.

3 https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-ajo-king-contains-hidden-drug-ingredient

4 https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredients

5 https://www.fda.gov/drugs/medication-health-fraud/public-notification-royal-honey-contains-hidden-drug-ingredient

6 https://www.fda.gov/drugs/medication-health-fraud/public-notification-rmflex-contains-hidden-drug-ingredient

7 https://www.fda.gov/drugs/medication-health-fraud/umary-contains-hidden-drug-ingredients

8 https://www.fda.gov/drugs/medication-health-fraud/umary-contains-hidden-drug-ingredients

9 https://www.fda.gov/drugs/medication-health-fraud/force-forever-may-be-harmful-due-hidden-drug-ingredients

10 https://www.fda.gov/drugs/medication-health-fraud/acido-hialuronico-contains-hidden-drug-ingredient