Champaklal Maganlal Homeo Pharmacy Private Limited

This letter is to advise you that the United States Food and Drug Administration (FDA) has determined that your firms manufacture, import, and/or distribute “Bebelyn Diarrhea” and “Bebelyn Colic,” and that these products are unapproved new drugs 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 these products 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).

Please also reference Warning Letter 320-23-13, issued on April 10, 2023 to Champaklal Maganlal Homeo Pharmacy (CMHP) Private Limited, that summarized significant violations of current good manufacturing practice (CGMP) regulations for its finished pharmaceuticals. Based on the records and information the firm provided, CMHP Private Limited failed to demonstrate adequate identity testing of the incoming high-risk component glycerin used to manufacture some of its drug products. The use of glycerin contaminated with diethylene glycol (DEG) or ethylene glycol (EG) has resulted in various lethal poisoning incidents in humans worldwide.

Your “Bebelyn Diarrhea” and “Bebelyn Colic” products are particularly concerning from a public health perspective because of these CGMP violations and because they are directed for use in infants and young children. For example, the product labels for “Bebelyn Diarrhea” and “Bebelyn Colic” read, in part, “Directions . . . children 3 months and older.” Unapproved New Drugs

Based on a review of the product labels provided by CMHP Private Limited in response to our request for records and other information pursuant to section 704(a)(4) of the FD&C Act, 21 U.S.C. 374(a)(4), and the websites, www.pharmadel.com, www.cadimportinc.com, and www.vasalsuper.store,1 your “Bebelyn Diarrhea” and “Bebelyn Colic” products are drugs under 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 that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

On the “Bebelyn Diarrhea” product label: • “Bebelyn temporarily relieves the symptoms of acute gastrointestinal distress associated with nonspecific diarrhea”

On the “Bebelyn Colic” product label: • “Bebelyn temporarily relieves the symptoms associated with colic . . . intestinal gas[,] bloating[,] cramping pains[, and] hiccups”

On the webpage https://pharmadel.com/pharmadel-life/bebelyn/: • “Bebelyn provides your consumers with newborn care items they can rely on. From everyday use wipes to homeopathic pain treatment medicines. Bebelyn can give the comfort you seek if your child is suffering from colic or diarrhea caused by an upset stomach. Our all-natural formulas are the fast-acting answers you’ve been looking for.”

On the webpage https://cadimportinc.com/wp-content/uploads/2023/03/Catalogo-2023-copia-14-compressed-3.pdf: • “Bebelyn Diarrhea . . . Relief: Diarrhea[,] Nausea[, and] Vomiting” • “Bebelyn Colics [sic] . . . Relief: Cramps[,] Bloating[, and] Abdominal pain”

On the webpage https://vasalsuper.store/products/bebelyn-drops-diarrhea-1-fl-oz-15ml: • “Bebelyn Drops Diarrhea temporarily relieves the symptoms of acute gastrointestinal distress associated with nonspecific diarrhea.”

On the webpage https://vasalsuper.store/products/bebelyn-colic-1-fl-oz-15ml: • “Bebelyn Colic temporarily relieves the symptoms associated with colic. intestinal gas; bloating; cramping pains; hiccups.”

Your “Bebelyn Diarrhea” and “Bebelyn Colic” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products 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 introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There are no FDA-approved applications in effect for “Bebelyn Diarrhea” and “Bebelyn Colic.” Accordingly, the introduction or delivery for introduction of these products into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that “Bebelyn Diarrhea” and “Bebelyn Colic” are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

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 injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these 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. Please direct any inquiries to FDA at FDAAdvisory@fda.hhs.gov.