WARNING LETTER
Graceleigh, Inc. dba Sammy’s Milk
MARCS-CMS 682538 —
August 14, 2024
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Erin Hendricks
Recipient Title
President
Graceleigh, Inc. dba Sammy’s Milk
3471 Via Lido, Ste 207
Newport Beach
,
CA
92663
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
August 14, 2024
WL 682538
Dear Ms. Hendricks:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your contract manufacturer’s facility located in
(b)(4)
from
(b)(4)
through
(b)(4)
. Based on information obtained during this inspection, as well as our review of your website at the Internet address https://sammysmilk.com and your social media websites at https://instagram.com/SammysMilk/, https://facebook.com/SammysMilk, and https://twitter.com/SammysMilk, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
Non-Notified Infant Formula
Based on representations made on your website and social media websites, Sammy’s Milk is an infant formula under section 201(z) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(z)] because it is a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. For example:
On the “About Feeding” page of your website at https://sammysmilk.com/about-feeding, which we reviewed in February 2024:
o “Rich in Nutrients…Naturally packed with essential vitamins and minerals like calcium and phosphorus, goat milk supports healthy growth and development in infants.”
“Bone Health…The calcium content in goat milk promotes strong bone and teeth development, crucial for the early stages of a baby’s growth.”
On the “Ask Sammy” page of your website at https://sammysmilk.com/ask-sammy, which we reviewed in February 2024:
o “Is Sammy’s Milk an infant formula?...Sammy’s Milk is safe [sic] we meet every FDA nutritional & manufacturing requirement for infant formula. We recommend speaking with your child’s pediatrician on our product’s suitability in your home”
o “Is Goat Milk the best alternative for Parents?...Breast is best, but not everyone can breastfeed successfully. Goat milk formula is an excellent alternative to breast milk, if the mother is unable to or chooses not to breastfeed.”
On your X page (formerly known as Twitter) at https://twitter.com/sammysmilk, which we reviewed in July 2024:
o September 28, 2022: “Holy Cow, have we got the #goatmilk formula for your babies and toddlers. If you haven't tried goats’ milk before we only have one question...why not? You know it’s safe, its healthy, it’s nutritious, and kids love it. Moms like you do too.”
On your Facebook page at https://www.facebook.com/sammysmilk, which we reviewed in April, June, and August 2024:
o June 16, 2023: “Sammy's Goat Milk Formula is healthy, nutritious, and safe for babies and toddlers.”
o February 18, 2024, post includes a picture of what appears to be a child less than 12 months of age and the following statement: “Elevate your little one’s nutrition and development. Sammy’s Milk Goat Milk formula is packed with 23 essential vitamins & minerals for OPTIMAL HEALTH & METHYLATION! Our premium blend includes reduced methylated Folate for enhanced stability and superior water solubility. Plus, highly absorbable Methylcobalamin for Vitamin B12. Choose Sammy’s Milk for quality you can trust!"
o December 27, 2023, post includes a picture of what appears to be a child less than 12 months of age and the following statement: “Give your kiddo the best start in life with Sammy's Milk Formula.”
On your Instagram page at https://www.instagram.com/sammysmilk, which we reviewed in February 2024:
o January 3, 2024, post: Instagram user “@mrs.patrice.e” commented, “Do you have a formula for babies 12 months and younger? Or just toddlers?” In response, “@sammysmilk” wrote, “@mrs.patrice.e we make one product that meets every FDA requirement for infant formula. You and your doctor can easily verify our label against their requirements on their website. Let us know we can best support you and your household.!!”
Your product is a new infant formula under section 412(c)(2) of the Act [21 U.S.C. § 350a(c)(2)] because you have not previously manufactured an infant formula. See also 21 CFR 106.3 (defining “new infant formula,” in part, as a formula “which has not previously been the subject of a submission under section 412(c)” of the Act). A person who introduces a new infant formula into interstate commerce must make a submission that complies with section 412(d)(1) of the Act [21 U.S.C. § 350a(d)(1)].
Under section 412(c)(1)(B) of the Act [21 U.S.C. § 350a(c)(1)(B)], no person shall introduce or deliver for introduction into interstate commerce a new infant formula unless such person has at least 90 days prior to marketing the new infant formula, made the submission required by section 412(d)(1). The failure to provide the notice require by section 412(c) is a prohibited act under section 301(s) of the Act [21 U.S.C. § 331(s)].
Following an April 16, 2024, call during which FDA discussed with you our concerns about your products, you notified FDA that you would be voluntarily recalling all Sammy’s Milk Goat Milk Toddler Formula product distributed between February 1, 2024, and April 18, 2024, by contacting all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on April 18, 2024, clarifying to the general public that this product is a toddler formula and should not be used as an infant formula. We also acknowledge that you made some changes to your website and social media pages, including, but not limited to, removing some of the above-mentioned statements. However, we continue to have concerns about certain images (e.g., of young infants) and other representations that remain on your social media pages, such as comments written by your firm in response to customer inquiries on your social media pages indicating that Sammy’s Milk Goat Milk Toddler Formula is intended to be consumed by infants.
Misbranded Food
In addition, we determined that your product was misbranded in accordance with section 403(a) of the Act [21 U.S.C. § 343(a)] in that its labeling was false or misleading. Specifically, based on our February 2024 review of the FAQ portion of your website at https://sammysmilk.com/ask-sammy, through which website you offer your products for sale, you represented that your product had been tested for
Cronobacter
. Your website stated, “Does Sammy’s Milk test for…contaminants?... Yes. Every batch is tested 3 times during the process for microbial contaminants. We also test every batch for . . . cronobacter . . ..” However, during the above-mentioned inspection of the manufacturer with whom you contracted to manufacture Sammy’s Milk, our investigator was informed that they had never tested product for
Cronobacter
. We recognize that you have since removed the portion of the above-noted statement relating to
Cronobacter
from your website, but this statement is particularly concerning to the Agency because it conveyed a false level of safety to consumers, given that no
Cronobacter
testing was performed.
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 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 electronically to: orahafwest5firmresponses@fda.hhs.gov.
Otherwise, a hardcopy response can be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Food Operations West - Division 5
19701 Fairchild Rd
Irvine, CA 92612
Refer to Unique Identification Number, CMS 682538, when replying. If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer at clarice.ahn@fda.hhs.gov, or 510-337-6854.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations - West Division 5
Content current as of:
09/03/2024
Regulated Product(s)
Food & Beverages