Healthwest Minerals, Inc. dba Mt. Capra Products

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September 11, 2024

In reply, refer to CMS 685115

AMENDED WARNING LETTER

Dear Mr. Stout:

The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address, https://mtcapra.com and your social media website at https://www.facebook.com/mtcapra in March and April 2024. Based on representations made on your websites at the time we reviewed them, your Goat Milk Formula Recipe Kit met the definition of 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 was a food which purported to be or was 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 your websites at https://mtcapra.com/category/goat-milk-formula/:

o “We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.”

• On your website at https://mtcapra.com/product/homemade-goat-milk-formula-kit:

o “The all-natural preferred alternative to commercial baby formula. This Goat Milk Recipe Kit supplies you with all of the wholesome, REAL FOOD ingredients your little one needs to thrive.”

o “This goat milk formula recipe kit contains all the ingredients you need to get started making your own goat milk formula at home! The kit will produce 256 oz of formula before you need to purchase more milk and lactose. Some of the ingredients in the kit will last much longer. Note: This recipe kit is not a finished, ready-to-mix, infant formula but rather a combination of different REAL FOODS for those who cannot or choose not to breastfeed. If breastfeeding is not an option, this kit could be the answer you’ve been searching for: the perfect DIY alternative to commercial infant formula.”

• On your Facebook page at https://www.facebook.com/mtcapra:

o Your February 12, 2024, post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .”

o Your October 18, 2023, post: “Our Goat Milk Formula was created nearly 10 years ago by our company President, Joe Stout. His newborn daughter, Liesl, was struggling with commercial formula. Since then, they have used the formula recipe with several of their 9 children, and provided a healthy solution for countless little ones and their parents. Swipe through to learn why our Goat Milk Formula is a standout. . . . Not only is goat milk the perfect substitute for cow milk, but its DNA is very similar to breast milk.”

At the time we reviewed your websites, your Goat Milk Formula Recipe Kit product was a new infant formula under section 412(c)(2)(A) of the Act [21 U.S.C. § 350a(c)(2)(A)] because you had 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 make such a submission at least 90 days prior to marketing a new infant formula is a violation of section 412(c)(1)(B) of the Act [21 U.S.C. § 350a(c)(1)(B)] and this is a prohibited act under section 301(s) of the Act [21 U.S.C. § 331(s)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit product distributed between May 1, 2023, and May 1, 2024. We are aware that you contacted 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 May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.

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.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to prevent the recurrence of future violations. If you believe that your products were not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021-4421, to the attention of Tracy K. Li, Compliance Officer. If you have any questions concerning this letter, you can contact Tracy K. Li at (425) 302-0428, or by email at Tracy.Li@fda.hhs.gov.

Sincerely,
/S/

Miriam R. Burbach
Program Division Director
Office of Human and Animal Food Operations West – Division 6