WARNING LETTER
Sambrosa Care Inc.
MARCS-CMS 673321 —
January 24, 2024
Product:
Drugs
Recipient:
Recipient Name
John F.R. de Wit, Pharm.D.
Sambrosa Care Inc.
9171 Wilshire Boulevard Suite 500
Beverly Hills
,
CA
90210
United States
john@dromenwinkel.com
john@sambrosacare.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
WARNING LETTER
January 24, 2024
Re: FEI #3018095920
Dear Dr. de Wit:
This letter concerns your firm’s distribution of the over-the-counter (OTC) combination antihistamine and nighttime sleep-aid drug product “Sambrosa sweet dreams Night Syrup.” “Sambrosa sweet dreams Night Syrup” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
Unapproved New Drug and Misbranding Violations
“Sambrosa sweet dreams Night Syrup” is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a combination antihistamine and nighttime sleep-aid drug product.
Examples of the claims from the products’ labeling, including your firm’s product website https://www.sambrosa.com/ where the product is available for purchase, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but are not limited to, the following:
“
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat” [from your product label]
“Looking for the best OTC sleeping syrup? Sambrosa Sweet Dreams is specially formulated to promote a good night’s rest. It combines the naturally-based ingredients of honey and 7 organic herbs with a small dose of doxylamine, which will help achieve both nighttime allergy relief and the quality rest you need...” [from your product website at https://www.sambrosa.com/product/sambrosa-300-ml/]
“Our Ingredients…Honey is quite amazing in its taste and in its countless health benefits; it is an antibacterial, anti-inflammatory, and contains antioxidants…California poppy extract is considered to be a nervine, which means that it may work to maintain a normal nervous system function, and it’s often used as a sedative to induce sleep…Hawthorn species are shrubs or small trees. Hawthorn was already a staple in herbal medicine, said to strengthen cardiovascular function and stimulate blood circulation…Hops adds a bitter flavor and is a stability agent. In herbal medicine this plant is known to benefit conditions such as anxiety and insomnia, and it contains phyto-estrogen which can relieve the symptoms of menopause… Mistletoe is famous for adding a romantic touch to Christmas, but there’s much more to it than just that—it’s used in herbal medicine for headaches, dizziness, energy loss, irritability and exhaustion…Passion Flower Is a climbing vine with beautiful flowers, and is recommended as a sedative and antispasmodic agent. It’s used for anxiety, insomnia and restlessness…Oats are very nutritious—they are a great source of dietary fiber, minerals, important vitamins and antioxidants. In herbal medicine, oats extract is used for anxiety and stress, and for its antimicrobial effects and sedative, soothing effects…White Chestnut is used as a reliever of repetitive thoughts and worrying.” [from your product website at https://www.sambrosa.com/shop/]
Unapproved New Drug Violations
Based on the above labeling claims, “Sambrosa sweet dreams Night Syrup” is intended for use as a combination antihistamine and nighttime sleep-aid drug product. As described below, your drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, 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 section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless it is lawfully marketed under section 505G of the FD&C Act. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product identified above.
Your “Sambrosa sweet dreams Night Syrup” is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to OTC antihistamine drug products, such products are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (hereafter M012).
1
However, your “Sambrosa sweet dreams Night Syrup” does not conform to conditions specified in M012.
2
Specifically, your product contains 9.78 mg of doxylamine succinate per each 3 mL dose. The product's directions for use for “adults and children 6 years of age and over,” which read “take 3 mL every 4 to 6 hours. Do not exceed 35 mL in 24 hours." may result in a daily dose of 114.1 mg of doxylamine succinate, which is 76.6 mg of doxylamine succinate more than the daily maximum dose of 37.5 mg that is allowed for children between 6 and 12 years of age and 39.1 mg above the 75 mg daily maximum dose that is allowed for adults and children above 12 years of age under M012.72(d)(8). For your information, M012.72(d)(8) states “Adults and children 12 years of age and over: oral dosage is 7.5 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 3.75 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours, or as directed by a doctor.”
Additionally, your product is labeled to contain the combination of active ingredients that include honey, California poppy, hawthorn, hops, mistletoe, passion flower, oats, and white chestnut. However, none of these ingredients in combination or as sole ingredients are acceptable or recognized as an active ingredient in M012. Although the immediate product label does not specifically list these ingredients as active ingredients, the claims on the product website as listed above, demonstrate that they are each an “active ingredient” as defined in 21 CFR 201.66(b)(2) because they are intended to furnish pharmacological activity.
3
Furthermore, these intended use claims go beyond the general intended uses and do not comply with the applicable final order.
4
Therefore, your “Sambrosa sweet dreams Night Syrup” drug product does not comply with the cold, cough monograph described above, and it is not otherwise marketed in accordance with section 505G. Thus, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Accordingly, this product is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section and 301(d) of the FD&C Act, 21 U.S.C. 331(d).
Misbranding Violations
“Sambrosa sweet dreams Night Syrup” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list 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 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 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. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.
Sincerely,
/S/
CAPT Tina Smith
Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
cc:
Bart Quik, Pharm.D.
Managing Director
Lelypharma BV
Zuiveringweg 42
Lelystad 8243PZ Netherlands (NLD)
bartquik@lelypharma.nl
(b)(4)
______________________
1
Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs", notably conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 C.F.R. part 330, prior to enactment of the CARES Act. In the case of OTC antihistamine drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter (OTC) Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000026, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.)
2
We note that your “Sambrosa sweet dreams Night Syrup” also appears to be indicated for use as a nighttime sleep aid. OTC nighttime sleep aid drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M010: Nighttime Sleep Aid Drug Products for Over the Counter Human Use (M010). Your product does not conform to the conditions set forth in this monograph because, among other things, “Sambrosa sweet dreams Night Syrup” is formulated with the active ingredient, doxylamine succinate, which is not permitted under M010 for use as a nighttime sleep-aid. Furthermore, neither M012 nor M010 include provisions allowing for a combination antihistamine and nighttime sleep-aid product.
3
Under 21 CFR 201.66(b), an active ingredient is a component of a drug intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
4
FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Sambrosa sweet dreams Night Syrup” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.
Content current as of:
01/30/2024
Regulated Product(s)
Drugs