C & A Naturistics

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.productosnaturalesca.com from May 2024 to February 2025, and has observed that during this time your website offered the products “AK Forte,”1 “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” “RenaLimp,” “Miel de Abeja Para Limpiar tus Ojos,” and “Ojo Roja Para Limpiar tus Ojos” for sale in the United States. In addition, FDA has obtained a sample of your “AK Forte” product.

As described below, these products are unapproved new drugs 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 “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” and “RenaLimp” products are misbranded drugs 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 “AK Forte” product contains the undeclared active pharmaceutical ingredients acetaminophen and diclofenac. Acetaminophen is a drug used to reduce pain and fever that is found in many prescription and over-the-counter drug products. Use of the product “AK Forte” poses a serious threat to consumers because it may result in unintentional acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience unintentional acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases. Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.

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.

Information on the label and/or labeling of your “AK Forte” product demonstrates that this product is marketed as a dietary supplement. 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. Given that diclofenac was not marketed as a dietary supplement or as food before Voltaren was approved, “AK Forte,” which contains diclofenac, 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 “AK Forte” 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.

We also note that your “Miel de Abeja Para Limpiar tus Ojos” and “Ojo Roja Para Limpiar tus Ojos” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

Your “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” “RenaLimp,” “Miel de Abeja Para Limpiar tus Ojos,” and “Ojo Roja Para Limpiar tus Ojos” products are drugs 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 that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

On your webpage, https://www.productosnaturalesca.com/product-page/ak-forte-con-ortiga-yomega100tab:

􀁸 “Highly effective in cartilage reconstruction”􀁸 “Fight Arthritis”􀁸 “Stops the advance of breakdown in joints”􀁸 “Anti-inflammatory and analgesic”􀁸 “Effective in joint problems of sports lessons”􀁸 “Improves mobility and normal joint function”

On your webpage, https://www.productosnaturalesca.com/product-page/moronel-te-100-calidad-la-plantade-la-vida-2oz-4oz-dist-by-aj-herbs:

􀁸 “Moronel is a medicinal plant that is used very effectively in the treatment of cancer, diabetes, cholesterol, blood pressure, prostatitis, arthritis, kidney problems, liver poisoning, among other diseases, in addition to naturally combating viruses and bacteria. [sic] & fungus.”

On your webpage, https://www.productosnaturalesca.com/product-page/jengibre-en-polvo-120-grs-ginger:

􀁸 “Assistant in: Gastritis . . . Nervous colitis . . . Colon Cancer”

On your webpage, https://www.productosnaturalesca.com/product-page/uva-ursi-100-natural-no-caffeine:

􀁸 “It decreases the accumulation of uric acid and reduces the risk of developing kidney stones.”􀁸 “It has antibacterial action against multiple bacteria such as Escherichia coli, staphylococci or pseudomonas, it also has antifungal activity against candida albicans.”􀁸 “[U]va ursi is effective in the treatment of herpes, wounds and burns.”􀁸 “[I]t is useful in the treatment of rheumatism and arthritis”

On your webpage, https://www.productosnaturalesca.com/product-page/renalimpc%C3%A1lculosrenales-piedras-en-los-ri%C3%B1ones:

􀁸 “RenaLimp Dissolves Kidney Stones”􀁸 “Assist in the treatment for kidneys [sic] symptoms such as kidney pain, infections, stones or kidney stones.”

On your webpage, https://www.productosnaturalesca.com/product-page/gotas-miel-de-abeja-para-limpiartus-ojos-eye-drops:

􀁸 “HONEYBEETo Clean Your Eyes

Natural SolutionIndicated For:Conjunctivitis. . .Inflamed Eyelids. . .mild infections”

On your webpage, https://www.productosnaturalesca.com/product-page/ojo-rojo-gotas-40ml:

􀁸 “Indicated For:Conjunctivitis. . .Inflamed Eyelidsmild infections”

Your “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” “RenaLimp,” “Miel de Abeja Para Limpiar tus Ojos,” and “Ojo Roja Para Limpiar tus Ojos” products are not generally recognized as safe and effective for their above referenced uses and, therefore, are “new drugs” 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). Because “AK Forte,” “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” “RenaLimp,” “Miel de Abeja Para Limpiar tus Ojos,” and “Ojo Roja Para Limpiar tus Ojos” are new drugs and there are no FDA-approved applications in effect for these products, these products are unapproved new drugs.

Introduction or delivery of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Your “AK Forte” 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 “AK Forte” product does not declare that the product contains acetaminophen or diclofenac. As previously mentioned, these undeclared ingredients in your “AK Forte” 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 “AK Forte” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

Additionally, a drug is misbranded under section 502(f)(1) of the FD&C 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 “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” and “RenaLimp” products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your “TE DE MORONEL,” “Jengibre en Polvo,” “Té Uva Ursi,” and “RenaLimp” products fail to bear adequate directions for their intended uses and, therefore, 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 drug products is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

We also documented that your website https://productosnaturalesca.com offered for sale “Artri Ajo King,”2 “Artri King,”3 “Ortiga Mas Ajo,”4 “RM Flex,”5 Reumo Flex,”6 and “Umary”7 to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your website revealed these products contained the 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 emphasizes 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.

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 693439” in the subject line of the email.