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WARNING LETTER

Honey Feast, Inc. MARCS-CMS 621651 — March 17, 2022

Delivery Method:

Via Email

Product:

Drugs
Food & Beverages

Recipient:

Recipient Name

Charles E. Sanford

Recipient Title

Owner

Honey Feast, Inc.

6906 Lake Nellie Rd.
Clermont, FL 34714-8368
United States

charlie@honeyfeast.com

Issuing Office:

Office of Human and Animal Food Operations East Division IV

United States

WARNING LETTER

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.External Link Disclaimer

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: orahafeast4firmresponses@fda.hhs.gov.

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

Sincerely,
/S/

Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations
East Division IV

摘要

本文是一篇发表于1959年5月2日的《自然》(Nature)杂志上的研究论文，作者为Gordon F. Townsend、Joseph F. Morgan和Barbara Hazlett。文章报告了蜂王浆及其主要成分10-羟基癸烯酸对小鼠白血病和腹水肿瘤的抗肿瘤活性研究。研究发现，将蜂王浆与肿瘤细胞在接种前混合，可以完全抑制可移植小鼠白血病的发展和小鼠腹水肿瘤的形成。通过分离研究，研究人员确定这种抗肿瘤活性存在于蜂王浆的主要脂肪酸—10-羟基癸烯酸中。该研究是作者们对蜂王浆化学成分和生物活性长期研究的一部分，为蜂王浆的抗癌特性提供了科学依据。

与问题相关的信息

这篇文章并非1955年发表的关于蜂王浆抗癌实验的研究，而是1959年5月2日发表在《自然》(Nature)杂志上的研究论文。

发表年份：1959年5月2日

作者：

• Gordon F. Townsend (安大略农业学院养蜂系)
• Joseph F. Morgan (国家健康与福利部，渥太华卫生实验室)
• Barbara Hazlett (多伦多大学治疗学系)

主要研究内容：
该研究探讨了蜂王浆及其主要成分10-羟基癸烯酸对小鼠白血病和腹水肿瘤的抗肿瘤活性。研究发现将蜂王浆与肿瘤细胞在接种前混合，可以完全抑制可移植小鼠白血病的发展和小鼠腹水肿瘤的形成。通过分离研究，研究人员确定这种抗肿瘤活性存在于蜂王浆的主要脂肪酸—10-羟基癸烯酸中。

文章引用了一些早期研究，包括1955年Johansson在《Bee World》发表的关于蜂王浆的文章，以及1940年Townsend和Lucas在《Biochemical Journal》发表的研究，表明这是作者们对蜂王浆化学成分和生物活性长期研究的一部分。

相关网页链接

1. Nature杂志链接 - 文章发表的期刊网站
2. 文章指标详情 - 提供文章的访问量、引用和Altmetric数据
3. 通过机构访问 - 机构订阅访问入口
4. 中国客户专用网站 - 为中国客户提供的订阅信息
5. 登录 - 用户登录入口
6. 了解机构订阅 - 机构订阅选项信息
7. 阅读常见问题 - 支持和帮助页面
8. 联系客户支持 - 客户支持联系方式
9. 下载参考文献 - 参考文献下载链接
10. 下载引用 - 文章引用下载链接

相关图片

1. 图片标题: 未知
   内容: 可能与41467_2021_26582_Fig1_HTML相关的研究图表
   来源: 未知
   链接: https://media.springernature.com/w215h120/springer-static/image/art%3A10.1038%2Fs41467-021-26582-4/MediaObjects/41467_2021_26582_Fig1_HTML.png

2. 图片标题: 未知
   内容: 可能与41467_2023_38668_Fig1_HTML相关的研究图表
   来源: 未知
   链接: https://media.springernature.com/w215h120/springer-static/image/art%3A10.1038%2Fs41467-023-38668-2/MediaObjects/41467_2023_38668_Fig1_HTML.png

3. 图片标题: 未知
   内容: 可能与41420_2023_1558_Figa_HTML相关的研究图表
   来源: 未知
   链接: https://media.springernature.com/w215h120/springer-static/image/art%3A10.1038%2Fs41420-023-01558-z/MediaObjects/41420_2023_1558_Figa_HTML.png

WARNING LETTER

Honey Feast, Inc. MARCS-CMS 621651 — March 17, 2022

Delivery Method:

Via Email

Product:

Drugs
Food & Beverages

Recipient:

Recipient Name

Charles E. Sanford

Recipient Title

Owner

Honey Feast, Inc.

6906 Lake Nellie Rd.
Clermont, FL 34714-8368
United States

charlie@honeyfeast.com

Issuing Office:

Office of Human and Animal Food Operations East Division IV

United States

WARNING LETTER

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.External Link Disclaimer

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: orahafeast4firmresponses@fda.hhs.gov.

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

Sincerely,
/S/

Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations
East Division IV