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Warning Letter # 628567

10/18/2022

Dear Ms. Stephenson:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.rosebudsrealfood.com and your social media website at www.facebook.com/RosebudsRealFood in June and August 2022, from which sites you take orders for Domestic Divas – Colds and Flu (Tea), Domestic Divas - No Pain No Gain Tea, Green Feather Homestead Mad As A Hatter Chai Tea, Rosebud’s Natural Seasonings Elderberry Syrup Kit, Rosebud’s Elderberry Lemonade, Rosebud’s Herbs & Spices Sencha Tea, Rosebud’s Natural Seasonings Jane’s Italian, Rosebud’s Fruit Butters Peach Blueberry, Rosebud’s Real Food Raw! Habanero Sriracha, and Rosebud’s Real Food Supertonic! Sriracha. The claims on your websites establish the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

Domestic Divas - Colds and Flu (Tea)
    “Eases the discomfort of a cold or flu”

Domestic Divas - No Pain No Gain Tea
    “Eases Muscular Pain”

Green Feather Homestead Mad As A Hatter Chai Tea
    “balancing to blood sugar”

Rosebud’s Natural Seasonings Elderberry Syrup Kit: From the product label, as shown on an image on your website at www.rosebudsrealfood.com/products/elderberry-syrupkit?_pos=1&_sid=4f1ea37c2&_ss=r:

• “Standard dose is ½ tsp - 1 tsp for kids and ½ - 1 tablespoon for adults. If the flu does strike, take the normal dose every 2-3 hours instead of once a day until symptoms disappear”

Rosebud’s Elderberry Lemonade, Rosebud’s Natural Seasonings Elderberry Syrup Kit (Elderberry ingredient): www.facebook.com/RosebudsRealFood

Facebook Post Date February 3, 2022

•  “‘Health benefits of the elder plant [elderberry] include naturally improving sinus issues, nerve pain, inflammation, chronic fatigue, allergies, constipation and even cancer. When used within the first 48 hours of onset of symptoms, the extract may even help relieve and shorten the duration of cold and flu symptoms as well.”

Facebook Post Date September 3, 2021

•  “Cancer Preventer”
•  “Blood Sugar Balancer”
•  “Cold & Flu Fighter”

Rosebud’s Herbs & Spices Sencha Tea: www.facebook.com/RosebudsRealFood

Facebook Post Date January 4, 2022

“Potential benefits of sencha green tea include:

•  anti-cancer properties
•  prevention of neurodegenerative diseases
•  anti-inflammatory properties
•  lowering bad cholesterol
•  anti-bacterial properties
•  prevention of some bacterial and virus infections
•  preventing tooth decay”

Real Food Raw! Habanero Sriracha, Natural Seasonings Jane’s Italian, and Real Food Supertonic! Sriracha (all of which contain garlic as an ingredient): www.facebook.com/RosebudsRealFood

Facebook Post Date January 22, 2022

•  “Garlic is antiviral, antibacterial, antifungal (including anti-mold), anti-parasitic, and rich in the phytochemical allicin, a sulfur compound that prevents disease.”
•  “Garlic kills off pathogens such as viruses and unproductive bacteria, which are behind so many mystery and chronic illnesses and symptoms.”
•  “Garlic helps fight colds, flus, strep throat, pneumonia-causing bacteria, and viral-related cancers.”

Facebook Post Date January 9, 2022

•  “Eat some garlic and lower that blood pressure!”
•  “Garlic has anti-inflammatory benefits and helps blood flow more easily through the body. Several studies found that blood pressure was lowered by 10%!!!!”

Rosebud’s Elderberry Lemonade and Rosebud’s Fruit Butters Peach Blueberry (which contain lemon): www.facebook.com/RosebudsRealFood

Facebook Post Date February 19, 2022

•  “[P]hytochemicals called limonoids in lemons and limes actually bond the vitamin C and calcium together, so that wherever one goes in the body, the other rides along. This enhances the bioavailability of each, and also creates alkalinity in the body to help prevent the growth of almost every type of cancer”
•  “The antioxidant flavonoids in lemons and limes are another ally in fighting disease. And when you’re dealing with a cold, flu, bronchitis, or pneumonia, lemon is one of the most effective mucus expellers you can find.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” 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.

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 safely 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 products Rosebud’s Natural Seasonings Elderberry Syrup Kit, Rosebud’s Elderberry Lemonade, Rosebud’s Real Food Raw! Habanero Sriracha, Rosebud’s Natural Seasonings Jane’s Italian, Rosebud’s Fruit Butters Peach Blueberry, Rosebud’s Herbs & Spices Sencha Tea and Rosebud’s Real Food Supertonic! Sriracha are intended for treatment 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, Rosebud’s Natural Seasonings Elderberry Syrup Kit, Rosebud’s Elderberry Lemonade, Rosebud’s Real Food Raw! Habanero Sriracha, Rosebud’s Natural Seasonings Jane’s Italian, Rosebud’s Fruit Butters Peach Blueberry, Rosebud’s Herbs & Spices Sencha Tea, and Rosebud’s Real Food Supertonic! Sriracha fail to bear adequate directions for their intended use and, therefore, the products are 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 these misbranded drugs 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 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 reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.

Sincerely,
/S/

Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East