HerbBaby, Inc. - Online Advisory Letter

Online Advisory Letter Reference #712868

 

August 20th, 2025

HerbBaby, Inc.
7425 Cullen Blvd,
Houston, TX 77051-1713
herbbabypowerup@gmail.com
Phone #713-485-0399

Asia Breann Holbert & Corey Graham:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at http://www.herbbabypowerup.com in July 2025 and has found that you take orders there for “Cancer Care Package,” “Autism Gummies,” “Autoimmune Care Package, “ Love Bug Care Package,” “HSV/Parasite Cleanse Package,” “Chill Pill Care Package,” “Eye Food Care Package,” “Liver Care Capsules,” “Respiratory Plus,” and “Diabetes Care Package.” Various claims and statements made on your website 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 website recommends or suggests the use of “Cancer Care Package,” “Respiratory Plus,” “Love Bug Care Package,” “Liver Care Capsules,” “Eye Food Care Package,” “Chill Pill Care Package,” “HSV/Parasite Cleanse Package,” “Diabetes Care Package,” “Autoimmune Care Package, and “Autism Gummies” to treat or prevent cancers, chronic obstructive pulmonary disease, sexually transmitted diseases (Syphilis, Gonorrhea, AIDS & HIV, Herpes Simplex), kidney stones, renal disorders, liver disorders, hepatitis, various eye diseases (e.g., glaucoma), mental disorders (depression, panic disorders), diabetes, Alzheimer’s disease, autoimmune disorder (lupus, multiple sclerosis), and Autism. 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 X 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.

For more information on the kinds of claims that establish that a product is intended for use as a drug, please see 21 CFR 101.93(f)-(g) and https://www.fda.gov/food/food-labelingnutrition/label-claims-conventional-foods-and-dietary-supplements. 

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(s) 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 products 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 Inspectorate Branch 
Division of Field Enforcement Office of Inspections and Investigations
U.S Food and Drug Administration
FDAAdvisory@fda.hhs.gov