WARNING LETTER

M.O.M. Enterprises, LLC MARCS-CMS 698651 — April 22, 2025

Product:: Food & Beverages

Recipient:: Recipient Name

Yasmin S. Kaderali; Recipient Title

Owner and CEO; M.O.M. Enterprises, LLC; 1001 Canal Boulevard, Suite C
Richmond, CA 94804
United States; Ykaderali@mommysbliss.com

Issuing Office:: Human Foods Program; United States

WARNING LETTER

April 22, 2025

RE: CMS 698651

Dear Ms. Kaderali:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility located at 1001 Canal Boulevard, Suite C, Richmond, California 94804, from August 19 through September 27, 2024. Based on inspectional findings and a review of your product labels collected during the inspection, as well as a review of your firm’s website, www.mommysbliss.com, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

At the conclusion of the inspection on September 27, 2024, our investigator provided your firm with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated October 17 and November 22, 2024, and January 10, 2025; we address your responses below.

Adulterated Dietary Supplements

The inspection of your facility from August 19 through September 27, 2024, identified serious violations of FDA’s regulations for current Good Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21 of the Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products Gripe Water Original, Gripe Water Night Time, Kids Cough Syrup & Mucus + Immunity Support, and Kids Cough Syrup & Mucus Night Time (including such product in the Day + Night Combo Packs) to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements.

Your significant violations of the cGMP requirements are as follows:

1. You failed to extend the review and investigation of a product complaint to all relevant batchesand records, as required by 21 CFR 111.560(c).

You initiated a market withdrawal of eight lots of Kids Cough Syrup & Mucus + ImmunitySupport, Kids Cough Syrup & Mucus Night Time, Baby Cough Syrup & Mucus + ImmunitySupport, and Baby Cough Syrup & Mucus Nighttime, including those in the Day + Night Combo Packs, on April 19, 2023, after your contract manufacturer notified you of early spoilage in these products. You reformulated the product to include the addition of glycerin to lower the water activity and also lowered the pH of the products, but your investigation did not extend to all relevant batches and records. After your firm initiated the market withdrawal, you received at least (b)(4) complaints from September 2023 through May 2024, in which complainants described bulging bottles of product and product where the lids popped off, including (b)(4) complaints for Kids Cough Syrup & Mucus Night Time, Lot Number (b)(4), EXP 03/25, which lot was not included in your market withdrawal. For example, complaint #(b)(4), received on December 1, 2023, for Kids Cough Syrup & Mucus Night Time, lot number (b)(4), stated that “(b)(4)” and described “(b)(4).” Relating to this complaint, your “(b)(4)” states, “(b)(4). The product has since reformulated the product [sic].” Your investigation, however, does not explain how such reformulation would have addressed the issue relating to bulging product bottles and product packaging that popped open, nor did it address the concerns relating to this specific lot that had not been withdrawn from the market.

In your October 17, 2024, response, you indicate the mold complaints were not new problems and were part of a previously investigated issue. However, your response does not explain how you determined that the issues were connected to complaints you received subsequent to the market withdrawal. You did not conduct additional investigations of these complaints to determine whether additional lots of product were affected by the known spoilage issue to determine if additional corrective actions were needed, even though your complaint records correlate these complaints to your market withdrawal.

2. You failed to follow written procedures for the requirements to review and investigate all product complaints, as required by 21 CFR 111.553. Your “(b)(4)” procedure, revision date March 14, 2019, SOP #(b)(4), and your “(b)(4)” procedure, effective date July 1, 2022, QA-1009, both require your quality control manager to review complaints to determine whether the complaint involves a possible failure of a dietary supplement to meet any of its specifications, and to review and approve decisions to investigate complaints and any findings and follow up actions, in accordance with 21 CFR 111.560(a) and 21 CFR 111.560(b). However, a review of complaints you received from December 2019 through August 2024 revealed complaints that were not investigated. For example:

a. Complaints received for your Gripe Water Original and Gripe Water Night Time under the category “(b)(4)” revealed there were (b)(4) complaints that were not investigated, (b)(4) of which met the criteria for a serious adverse event.

b. Complaints received for your Gripe Water Original and Gripe Water Night Time under the category “(b)(4),” “(b)(4),” and “(b)(4)” revealed at least (b)(4) complaints that were not investigated. Of these (b)(4) complaints, (b)(4) were resolved as “(b)(4)” with no further action documented.

In your October 17, 2024, response, you committed to updating your (b)(4) procedure and conducting a retrospective review of all complaints received from 2019-2024 to ensure all are fully investigated and completely documented. You also indicated that any complaints that are determined to be a serious adverse event will be reported per your revised (b)(4) procedure, and that you will conduct retraining of your employees on the revised procedure, as well as perform monthly monitoring of your firm’s compliance with the revised procedure.

In your response dated November 22, 2024, you provided a copy of your revised (b)(4) procedure and stated that your employee retraining was completed on November 20, 2024. You also indicated your retrospective review of complaints is in-progress. As your corrective actions are still in progress, we cannot evaluate the adequacy of your corrections at this time.

3. You failed to comply with the requirements for records of product complaints in 21 CFR111.570. Specifically, written records of product complaints that are related to good manufacturing practice must include the findings of the investigation and follow-up action taken when an investigation is performed [21 CFR 111.570(b)(2)(ii)(F)]. However, a review of your electronic consumer complaint records revealed your complaint records, in which your Quality Manager stated that (b)(4). For example, complaint #(b)(4), received October 4, 2021, in which the complainant described their baby turning blue after administering Gripe Water Night Time, your electronic record indicates the quality investigation is completed. However, you were unable to provide documentation pertaining to the quality review and investigation of this complaint.

In your initial response, you committed to revising your (b)(4) procedure and including a detailed template which will be designed to capture all required steps and follow-up actions for complaint investigations. You provided FDA with this revised procedure and the consumer complaint investigation form. We will evaluate the adequacy of this corrective action during our next inspection of your firm.

Failure to Submit a Serious Adverse Event Report

You failed to submit a Serious Adverse Event Report (SAER) for a dietary supplement within 15 business days after receiving a report about the adverse event, as required by section 761(c) of the Act [21 U.S.C. 379aa-1(c)]. Specifically, you received reports of at least (b)(4) serious adverse events between December 2019 and August 2024, but did not submit a SAER as required. For example, our inspection found you received reports of infants choking, infants that stopped breathing, and infants that were admitted to the hospital after being administered your Gripe Water Original products. For example:

a. On January 19, 2021, you received a complaint (#(b)(4)) in which the complainant described giving their two-month-old baby Gripe Water Original on January 12, 2021, and a second dose on January 13, 2021, when they noticed he had a fever of 101.8 degrees. The complainant explained they called the local emergency room which advised the complainant to bring the baby to the hospital. The complainant explained their baby was sent to a bigger hospital where additional tests, including blood work and a spinal tap were performed and he was admitted to the hospital where he stayed until January 17, 2021. Per the complainant, the tests were positive for E. coli, although the complainant reported the hospital could not tell them what caused the infection.

b. On October 7, 2021, you received a complaint (#(b)(4)) in which the complainant described their daughter was born prematurely, they used Gripe Water Original and the infant vomited and was taken to the emergency room. The complainant further explained the infant “(b)(4).”

c. On October 15, 2021, you received a complaint (#(b)(4)) in which the complainant described their six-week-old infant choked on Gripe Water Original. Per your complaint record, the complainant explained their infant “(b)(4).” Your complaint record further explains the complainant attempted cardiopulmonary resuscitation (CPR) multiple times until the infant began breathing again. The complainant also reported that paramedics were called and looked over their infant.

d. On March 30, 2022, you received a complaint (#(b)(4)) in which the complainant gave their baby Gripe Water Original and the baby “(b)(4).” The complainant further explained they were “(b)(4).”

e. On May 4, 2023, you received a complaint (#(b)(4)) in which the complainant described giving their baby Gripe Water Original and “(b)(4).”

f. On July 30, 2024, you received a complaint (#(b)(4)) in which the complainant described their child choking on Gripe Water Original on two different occasions. The complainant explained they gave their two-month-old some Gripe Water Original, “(b)(4).”

Under section 761(c) of the Act, you must submit a report of a serious adverse event associated with any of your dietary supplements no later than fifteen (15) business days after a report of the event is received through the address or phone number provided on your dietary supplement products.

Because prompt submission of such serious adverse event reports is important for public health reasons, the agency recommends that all serious adverse events be reported to FDA within fifteen (15) business days of receipt regardless of the means by which you receive the initial report. These serious adverse event reports should be submitted under the MedWatch Form 3500A. More information on adverse event reporting can be found on FDA’s website at www.fda.gov, in the publication “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.”

In your written response letters, with respect to the observation relating to serious adverse event reporting, you provided a revised (b)(4) procedure and complaint investigation form that appear to provide adequate details for assessing the severity of the adverse events. You also committed to conducting a retrospective review of the (b)(4) complaints identified during our inspection as reportable events using your revised (b)(4) procedure and reporting any complaints that are deemed reportable.

In your October 17, 2024, response, you quote from the guidance “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act” and explain that you interpreted the FDA guidance as stating the details of the event come from the perspective of trained health care professionals. However, FDA’s guidance clearly states, as quoted in your response, “[W]e encourage responsible persons to use trained health care practitioners to elicit information from reporters, computer-assisted interview technology, targeted questionnaires, and/or other appropriate methods that help focus the line of questioning.” It does not appear that your firm was using either trained healthcare professionals, computer-assisted interview technology, targeted questionnaires, or other methods that would help focus the line of questioning; your (b)(4) procedure required customer service representatives to determine whether a complaint required escalation as an adverse event or serious adverse event. It is not a requirement that the details of events come from trained healthcare professionals; it does not require “(b)(4)” as stated in your response. In fact, the guidance defines an initial reporter as the person who first notifies the responsible person about the serious adverse event and “can be the patient, a family member, or some other person (e.g., doctor, pharmacist).”

According to your November 22, 2024, response, as a result of your retrospective review of the complaints identified during our inspection, you are in the process of reporting (b)(4) of the complaints to FDA as SAERs, and are re-opening the remaining complaints for one year in order to try and gather additional information needed for reporting the SAERs. Per your response, you have concluded these remaining complaints are also qualifying events per your procedure, but do not have complete data elements.

Of the remaining complaints that you identified as qualifying events, the missing data element for many of these complaints is listed as “(b)(4).” However, per the complaint records reviewed during our inspection, the product name is identified as Gripe Water Original for each of these complaints. It is unclear why the complaint records reviewed during our inspection identified the product as “Gripe Water Original” for each of these complaints, but your retrospective review has now determined the complainant didn’t specify the product.

Misbranded Dietary Supplements

1. Your Gripe Water, Gripe Water Night Time, and Kids Cough Syrup & Mucus Day + Night Combo Pack products are misbranded within the meaning of section 403(q)(5)(F) [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.9, 21 CFR 101.36, and 21 CFR 101.2. For example:

a. The product’s inner bottle labels do not bear nutrition information, as required by 21 CFR 101.36. The unit container is exempted from these requirements if the unit container bears the statement “This Unit Not Labeled for Retail Sale” [21 CFR 1.24(a)(24)].

b. The dosage guide and/or directions for use are placed above the Supplement Facts label, which is not in accordance with 21 CFR 101.2(a) and (e). Nutrition information should appear on the principal display panel (PDP) or directly to the right of the PDP with no intervening material in between.

c. For your Gripe Water Night Time and Kids Cough Syrup & Mucus Day + Night Combo Pack, the serving size in the Supplement Facts labels fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b) and must be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams).

Unapproved New Drug

FDA reviewed your website at the internet address www.mommysbliss.com in December 2024 and determined that you take orders there for your Gripe Water Original. The claims on your website establish that your product Gripe Water Original is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. Thus, in addition to being an adulterated and misbranded dietary supplement, your Gripe Water Original is also an unapproved new drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)].

Examples of some of the claims that provide evidence that your Gripe Water Original product is intended for use as a drug include:

From the blog post on your website: Acid Reflux = The Pits – Mommy's Bliss

• “Acid reflux, also known as gastroesophageal reflux or GER, is when acids and content of the stomach come back up into the baby’s esophagus. It happens because the lower esophageal sphincter isn’t fully developed. . . .[I]f [a baby’s esophageal sphincter] fails to develop correctly or becomes weak, a baby may develop GERD (gastroesophageal reflux disease) which has more severe complications. . . .

How do you know if your baby has acid reflux?
The symptoms of acid reflux are typically clear and easy to read….

1. Frequent Vomiting….2. Irritability….The acid of the digestive juices irritates the stomach and esophagus….3. Persistent Coughing or Wheezing….There is a link between acid reflux, wheezing, coughing, and even asthma….5. Colic The persistent crying of a colicky baby could be a symptom of reflux. The irritation of the stomach and the esophagus from all those digestive juices may trigger your baby into colic….How do you help a baby with acid reflux?....

Try Gripe Water

Gripe water can also be a great way to ease symptoms of acid reflux in infants. It is a natural approach to help reduce the stomach acid that causes pain. . . .

Mommy’s Bliss Gripe Water is a safe and gentle way to help ease your baby’s stomach discomfort. The organic ginger and fennel relieve the irritation and prevent the stomach acid from flowing up into the esophagus. Fennel is known for its ability to reduce inflammation and acid in the stomach while ginger’s phenolic compounds help relieve irritation and reduce gastric contractions.”

Additionally, your blog post titled “Acid Reflux = The Pits,” in discussing the “link between acid reflex, wheezing, and coughing,” links to an article from the Mayo Clinic article entitled “Asthma and acid reflux: Are they linked?” (Asthma and acid reflux: Are they linked? - Mayo Clinic). This link from your blog further suggests that your Mommy’s Bliss Gripe Water Original is intended for the cure, mitigation, treatment, or prevention of GERD and asthma.

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Misbranded Drug

A drug is misbranded under section 502(f)(1) of the 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 safety 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 Gripe Water Original is intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purpose. Accordingly, Gripe Water Original fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

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 (15) working days of receipt of this letter, of the specific steps you have taken to address 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 cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835, or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. If you have any questions, you may email us at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #698651 on any submissions and within the subject line of any emails.

Sincerely,

/S/
Laura Akowuah, JD, MPH
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration