June 15, 2026 FDA Warning Letter: Happiest Baby, Inc. Cited for Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

FDA Warning Letter — Violations FDA cited at Happiest Baby, Inc.

WARNING LETTER Happiest Baby, Inc. MARCS-CMS 718306 — June 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Dr. Harvey Karp Recipient Title Chief Executive Officer Happiest Baby, Inc. 11390 W. Olympic Blvd. Ste. 450 Los Angeles , CA 90064 United States (b)(4) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS #718306 June 15, 2026 Dear Dr. Karp: During an inspection of your firm located in Los Angeles, CA from July 21, 2025 through July 25, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SNOO Smart Sleeper and the SNOO Hospital Bundle. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. We received responses from Dr. Harvey Karp, CEO, dated August 15, 2025, and February 26, 2026, concerning the observations and discussion items from the inspection. Unapproved Device Violations Our inspection and review of your website and marketing materials revealed that the SNOO Smart Sleeper and the SNOO Hospital Bundle are adulterated under section 501(f)(1) of the Act, 21 U.S.C. § 351(f)(1), and misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o). The SNOO Smart Sleeper and SNOO Hospital Bundle are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the devices as described and marketed. The SNOO Smart Sleeper and SNOO Hospital Bundle are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices without submitting to FDA a notice or other information respecting the significant changes or modifications that your firm made to the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). The SNOO Smart Sleeper was authorized under DEN210039 with the following indications: “The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.” In addition, the Device Description section of FDA’s Decision Summary for DEN210039 specifies the following: “The SNOO Sleep Sack is a cotton swaddle with fixed wings made of woven cotton fabric that extend to the right and left of the infant's body. Three sizes of sleep sacks (small 5-12 lbs, medium 12-18 lbs, and large 18-25 lbs) are provided with each bassinet to accommodate the growing baby.” However, there is evidence that your firm has significantly changed or modified the SNOO Smart Sleeper by introducing two new sizes of sleep sacks, as described in more detail below. 1. X-Small Sleep Sack Our inspection and review of your firm’s website, https://www.happiestbaby.com (last reviewed on May 7, 2026), revealed that your firm is currently distributing an X-Small Sleep Sack for infants 4-8 lbs. 1 When FDA granted your De Novo request, it authorized use of the SNOO bassinet with three sizes of sleep sacks (Small 5-12 lbs, Medium 12-18 lbs, and Large 18-25 lbs). Your new X-Small Sleep Sack has smaller dimensions than any of the sleep sacks that