[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-bellas-nutri-shop-inc-737491-10262026":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":27,"updated_at":28},22105,"bellas-nutri-shop-inc-737491-10262026","Warning Letter","Bella’s Nutri Shop Inc.",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2026-11-03","2026-10-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbellas-nutri-shop-inc-737491-10262026","737491","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>Bella’s Nutri Shop Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>16524 Nectarine Way\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Lake Elsinore\u003C\u002Fspan>, \u003Cspan>CA\u003C\u002Fspan> \u003Cspan>92530\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:Isabellaaa1967@gmail.com\"> Isabellaaa1967@gmail.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>October 26, 2026\u003C\u002Fp>\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference Number: 737491\u003C\u002Fp>\u003Cp>To Bella’s Nutri Shop Inc.:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, www.bellasnutrishop.com, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Additionally, FDA obtained a sample of your “Tawon Liar” product and has serious safety concerns about it. FDA confirmed through laboratory analysis that this product contains hidden drug ingredients, specifically dexamethasone, tapentadol, and meloxicam, not listed on the product label. Dexamethasone is a steroid medication commonly used to reduce inflammation. However, it can weaken the immune system, making it harder for the body to fight infections. It also can cause high blood sugar, muscle damage and mental health problems. Tapentadol, the active ingredient in the FDA-approved prescription drugs Nucynta and Nucynta ER, is a controlled opioid substance used to treat severe pain. Common side effects of tapentadol include drowsiness, dizziness, nausea, vomiting and constipation. It also can cause life-threatening effects such as slowed or stopped breathing and severe low blood pressure. As with all opioid pain medicines, there are serious risks of misuse and abuse, addiction, overdose and death. Meloxicam is a type of pain and inflammation reliever known as an NSAID. NSAIDs can increase the risk of serious heart problems, such as heart attack and stroke, and can cause serious gastrointestinal problems, such as bleeding, ulcers or life-threatening tears in the stomach or intestinal lining. Meloxicam can interact with other medications, especially other NSAID-containing products, and may significantly increase the risk of these serious side effects\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of your website www.bellasnutrishop.com in August 2026. In addition, FDA obtained a sample of your “Tawon Liar” through your website, www.bellasnutrishop.com. Based on our review, “Tawon Liar” is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Based on a review of your website, “Tawon Liar” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>On the product label (translated from Chinese):\u003C\u002Fp>\u003Cul>\u003Cli>“Relieve:\u003Cbr>o Gout\u003Cbr>o Cholesterol\u003Cbr>o Stamina\u003Cbr>o Aches and Pains”\u003C\u002Fli>\u003Cli>“Uses:\u003Cbr>Treating Gout, Aches and Pains, Cold, Lower Cholesterol, Boosts Energy and Stamina”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>“Tawon Liar” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>Misbranded Drug Violations\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>“Tawon Liar” 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 “Tawon Liar” does not declare that it contains dexamethasone, tapentadol, or meloxicam. Consumers may purchase and use this product without knowing it contains ingredients that may cause serious harm or interact dangerously with other medications. The failure to disclose dexamethasone, tapentadol, and meloxicam in the product labeling renders “Tawon Liar” misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).\u003C\u002Fp>\u003Cp>The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.\u003C\u002Fp>\u003Cp>Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number “737491” in the subject line of the email.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.fda.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs and Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\nBella’s Nutri Shop Inc.\n\n16524 Nectarine Way\n\nLake Elsinore, CA 92530\n\nUnited States\n\nIsabellaaa1967@gmail.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 26, 2026\nWARNING LETTER\nReference Number: 737491\nTo Bella’s Nutri Shop Inc.:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, www.bellasnutrishop.com, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\nAdditionally, FDA obtained a sample of your “Tawon Liar” product and has serious safety concerns about it. FDA confirmed through laboratory analysis that this product contains hidden drug ingredients, specifically dexamethasone, tapentadol, and meloxicam, not listed on the product label. Dexamethasone is a steroid medication commonly used to reduce inflammation. However, it can weaken the immune system, making it harder for the body to fight infections. It also can cause high blood sugar, muscle damage and mental health problems. Tapentadol, the active ingredient in the FDA-approved prescription drugs Nucynta and Nucynta ER, is a controlled opioid substance used to treat severe pain. Common side effects of tapentadol include drowsiness, dizziness, nausea, vomiting and constipation. It also can cause life-threatening effects such as slowed or stopped breathing and severe low blood pressure. As with all opioid pain medicines, there are serious risks of misuse and abuse, addiction, overdose and death. Meloxicam is a type of pain and inflammation reliever known as an NSAID. NSAIDs can increase the risk of serious heart problems, such as heart attack and stroke, and can cause serious gastrointestinal problems, such as bleeding, ulcers or life-threatening tears in the stomach or intestinal lining. Meloxicam can interact with other medications, especially other NSAID-containing products, and may significantly increase the risk of these serious side effects\nFDA Review\nViolations were identified and documented during a review of your website www.bellasnutrishop.com in August 2026. In addition, FDA obtained a sample of your “Tawon Liar” through your website, www.bellasnutrishop.com. Based on our review, “Tawon Liar” is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nThis review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.\nUnapproved New Drug Violations\nBased on a review of your website, “Tawon Liar” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:\nOn the product label (translated from Chinese):\n“Relieve:\no Gout\no Cholesterol\no Stamina\no Aches and Pains”\n“Uses:\nTreating Gout, Aches and Pains, Cold, Lower Cholesterol, Boosts Energy and Stamina”\n“Tawon Liar” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nMisbranded Drug Violations\n“Tawon Liar” 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 “Tawon Liar” does not declare that it contains dexamethasone, tapentadol, or meloxicam. Consumers may purchase and use this product without knowing it contains ingredients that may cause serious harm or interact dangerously with other medications. The failure to disclose dexamethasone, tapentadol, and meloxicam in the product labeling renders “Tawon Liar” misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).\nThe introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\nConclusion\nAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.\nSend your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number “737491” in the subject line of the email.\nPlease note FDA posts warning letters on www.fda.gov.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration","2026-11-10T01:02:22.407+00:00",[22,23,24,9,25,26,26,26],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-26T04:00:00Z\">10\u002F26\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbellas-nutri-shop-inc-737491-10262026\">Bella’s Nutri Shop Inc.\u003C\u002Fa>","Unapproved New Drugs\u002FMisbranded ","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:02:22.955599+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-11-09T02:00:35.105+00:00","2026-11-09T02:00:29.052+00:00","2026-11-09T02:00:32.696+00:00","2026-11-12T04:02:32.647+00:00","2026-09-07T05:17:28.839+00:00","2026-11-09T02:00:36.308+00:00","2026-11-10T01:03:48.189+00:00"]