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Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store

 

Black HHS-Blue FDA Logo

 

 
Food and Drug Administration
Silver Spring, MD 20993-0002

  

November 7, 2018                                                                       

Healthcare Products, LLC
Britney Barnet
d/b/a The Alzheimer's Store
d/b/a MindCare Store
340 Royal Poinciana Way, #317 
Palm Beach, FL 33480
contact@alzstore.com
contact@mindcarestore.com
orders@mindcarestore.com

 

RE: Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch, Refresh Aromatherapy Patch, Rested Aromatherapy Patch, Aromatherapy Patch Sample Pack

Dear Ms. Barnet:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.alzstore.com and www.mindcarestore.com in October 2018 and have found that you take orders there for Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch,
Refresh Aromatherapy Patch, Rested Aromatherapy Patch, and Aromatherapy Patch Sample Pack. FDA also reviewed your Facebook and Twitter social media accounts at https://www.facebook.com/TheAlzheimersStore/,
https://twitter.com/alzstore, https://www.facebook.com/MindCareStore/ and https://twitter.com/MindCareStore. Various claims and statements made on your websites and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. For example, your websites recommend or suggest the use of Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch, Refresh Aromatherapy Patch, Rested Aromatherapy Patch, and Aromatherapy Patch Sample Pack to treat Alzheimer's disease, dementia, depression, stroke, autism, and hypertension. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. 

These products are also new drugs as defined under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. See 21 U.S.C. §§ 355(a) and 331(d). Your drug products do not have FDA-approved applications as required by 21 U.S.C. § 355.

We advise you to review all materials through which you communicate to consumers the intended uses of your products, and to either submit a new drug application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. This would include reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts), as well as any other promotional materials, and removing product claims, consumer testimonials, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases.

Within 30 calendar days of the date of this letter, please correct the violations described in this letter and notify FDA, via electronic mail at FDAadvisory@fda.hhs.gov, that the violations have been corrected. Include the Online Advisory Letter Reference number (located in the upper right portion of this letter) in all your communications to FDA regarding this matter.

After 30 days from the date of this letter, if your website or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for unapproved new drugs illegally marketed for serious diseases.

This letter is not intended to be an all-inclusive review of your website(s) or a list of all violations of law that exist in connection with your products, your website(s) and other product labeling, or at your facilities. FDA expects you to take the necessary steps to ensure that all your products comply with the laws and regulations enforced by FDA.


Sincerely,

Health Fraud Branch
U.S. Food and Drug Administration
 

November 7, 2018                                                                       

Healthcare Products, LLC
Britney Barnet
d/b/a The Alzheimer's Store
d/b/a MindCare Store
340 Royal Poinciana Way, #317 
Palm Beach, FL 33480
contact@alzstore.com
contact@mindcarestore.com
orders@mindcarestore.com

 

RE: Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch, Refresh Aromatherapy Patch, Rested Aromatherapy Patch, Aromatherapy Patch Sample Pack

Dear Ms. Barnet:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.alzstore.com and www.mindcarestore.com in October 2018 and have found that you take orders there for Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch,
Refresh Aromatherapy Patch, Rested Aromatherapy Patch, and Aromatherapy Patch Sample Pack. FDA also reviewed your Facebook and Twitter social media accounts at https://www.facebook.com/TheAlzheimersStore/,
https://twitter.com/alzstore, https://www.facebook.com/MindCareStore/ and https://twitter.com/MindCareStore. Various claims and statements made on your websites and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. For example, your websites recommend or suggest the use of Aromatherapy for Dementia Memory Kit Premier Edition, Aromatherapy for Dementia Memory Kit Second Edition, Bodyguard Blend Essential Oil, ClearMind Blend Essential Oil, Lavender Essential Oil, Attention Aromatherapy Patch, Calming Aromatherapy Patch, Lavender Aromatherapy Patch, Perk Up Aromatherapy Patch, Refresh Aromatherapy Patch, Rested Aromatherapy Patch, and Aromatherapy Patch Sample Pack to treat Alzheimer's disease, dementia, depression, stroke, autism, and hypertension. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. 

These products are also new drugs as defined under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. See 21 U.S.C. §§ 355(a) and 331(d). Your drug products do not have FDA-approved applications as required by 21 U.S.C. § 355.

We advise you to review all materials through which you communicate to consumers the intended uses of your products, and to either submit a new drug application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. This would include reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts), as well as any other promotional materials, and removing product claims, consumer testimonials, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases.

Within 30 calendar days of the date of this letter, please correct the violations described in this letter and notify FDA, via electronic mail at FDAadvisory@fda.hhs.gov, that the violations have been corrected. Include the Online Advisory Letter Reference number (located in the upper right portion of this letter) in all your communications to FDA regarding this matter.

After 30 days from the date of this letter, if your website or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for unapproved new drugs illegally marketed for serious diseases.

This letter is not intended to be an all-inclusive review of your website(s) or a list of all violations of law that exist in connection with your products, your website(s) and other product labeling, or at your facilities. FDA expects you to take the necessary steps to ensure that all your products comply with the laws and regulations enforced by FDA.


Sincerely,

Health Fraud Branch
U.S. Food and Drug Administration