- Delivery Method:
- Via Email
Food & Beverages
Recipient NameCharles E. Sanford
- Honey Feast, Inc.
6906 Lake Nellie Rd.
Clermont, FL 34714-8368
- Issuing Office:
- Office of Human and Animal Food Operations East Division IV
March 17, 2022
22-HAFE4-WL-04 / CMS No. 621651
Dear Mr. Sanford:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://honeyfeast.com in February through March 2022 and has determined that you take orders there for the products Raw Honeycomb; Tupelo Honey Raw; and Superfood Honey with Royal Jelly, Bee Pollen, Propolis. The claims on your website establish that these 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 Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
On your website https://honeyfeast.com, under the heading “Blog”:
a) Under the blog entry titled “Honey’s Other Amazing Benefits,” dated December 25, 2018, which states:
- “These phytonutrients are where the many amazing antioxidants in honey are sourced from, and give honey its anti-fungal and antibacterial powers! It is believed that honey gets its anticancer and immunity boosting properties as a result of these phytonutrients as well.”
- “Studies have shown honey to be an effective treatment against the H. Pylori bacteria, commonly responsible for stomach ulcers . . . .”
b) Under the blog entry titled “Honey is Great for Home Remedies. Honey the Home Remedy,” dated December 17, 2018, which states:
- “Honey is an Effective Cough Suppressant”
- “Honey Can Be Used To Treat Wounds: There has been quite a bit of research on the efficacy of honey as a treatment for wounds, and the results show that it can be quite effective. In one study, honey applied topically to a wound was found to kill every strain of bacteria present!...When other treatments fail, honey was found to aid the healing processes and even prevent infections entirely!”
- “[H]oney was found to do better at suppressing a cough than the common ingredient found in most OTC cough medicine, dextromethorphan!””
c) Under the blog entry titled “Honey is More Than Just Sugar! Honey Has Many Health Benefits,” dated December 16, 2018, which states:
- “Honey has anti-inflammatory effects…may also relieve symptoms of seasonal allergies!”
- “Honey acts as a cough suppressant . . . . Honey can be just as effective as suppressing a cough as Dextromethorphan, the ingredient found most commonly in over the counter cough medication.”
- “[I]t can act as a natural vaccine of sorts, against comment allergens.”
d) Under the blog entry titled “Honey tastes great! Honey has wonderful benefits for the body,” dated December 12, 2018, which states:
- “Antioxidants found in honey…have been linked to a reduction in the risk of stroke, heart attack, and even some types of cancer!”
- “If you consume honey regularly, you may notice a slight reduction in blood pressure, as well as a reduction in ‘bad’ cholesterol. As a result, you’ll be at a reduced risk of developing heart disease, as well as atherosclerosis!”
- “Honey Aids In the Healing of Burns and Wounds: Honey has been used…as a topical treatment for wounds and burns with great effect!...In recent studies, honey was found to be an effective treatment for partial-thickness burns and wounds that had become infected post surgery. Researchers attribute honey’s healing abilities to its anti-inflammatory and antibacterial properties . . . .”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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) and 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 Raw Honeycomb; Tupelo Honey Raw; and Superfood Honey with Royal Jelly, Bee Pollen, Propolis 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 products safely for their intended purposes. Accordingly, your products Raw Honeycomb; Tupelo Honey Raw; and Superfood Honey with Royal Jelly, Bee Pollen, Propolis 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 written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. You may email a copy of your response to email address: email@example.com.
If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at telephone number (787) 729-8707 or via email at Marilyn.Santiago@fda.hhs.gov
Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations
East Division IV