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  5. Natural Ginger, Corp/Jonaus Corp - 679765 - 06/25/2024
  1. Warning Letters

WARNING LETTER

Natural Ginger, Corp/Jonaus Corp MARCS-CMS 679765 —

Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jose Ramirez
Recipient Title
Owner
Natural Ginger, Corp/Jonaus Corp

7781 NW 73rd Court, Suite B
Medley, FL 33166-2201
United States

jose@naturgin.com
Issuing Office:
Division of Human and Animal Food Operations East IV

United States

WARNING LETTER

June 25, 2024

24-HAFE4-WL-02 / CMS No. 679765

Dear Mr. Ramirez:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address, www.naturgin.com in June 2024 and has determined that you take orders for the products Syrup for Children Ginger, Honey, and Aloe Vera; Syrup for Adults Ginger and Honey; Syrup for Adults Forte Ginger, Honey, and Aloe Vera; AFA Blue Green Algae 1000 mg; Magnesium Complex All in One Capsule Magnesium and Potassium; and Vitamin C 1000 mg/caps. We also reviewed your social media website at https://www.facebook.com/naturgin/ where you direct consumers to your website, www.naturgin.com, to purchase your products. The claims on your website and social media 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:

Syrup for Children Ginger, Honey, and Aloe Vera
https://naturgin.com/product/ginger-honey-aloe-vera-syrup-for-children-5-fl-oz-150ml-for-a-healthy-throat /

Under the “Description” section of your product webpage:

  • “This cough syrup is a dietary supplement which has a generous mix of honey, ginger and Aloe Vera that can be safely consumed by kids and will leave their throats clear, will alleviate digestive inflammation and can diminish severe coughing.”
  • “While the honey is a millenary soother for sore throats for its various antimicrobial properties; ginger is known for being anti-inflammatory….”
  • “Naturgin syrup for children also contains Aloe Vera, which is known for being the perfect cure for children’s common colds as it stops acute coughing and has potent anti-bacterial properties that will prevent the re-growth of microorganisms”

Under the “PROPERTIES” section of your product webpage:

  • “ALLEVIATES SORE THROATS: Naturgin has a generous amount of honey which will quickly reduce inflammation….”
  • “DIMINISHES PHLEGM: Naturgin’s contains a generous dose of ginger, which has been used for centuries as a natural decongestant and antihistamine.”
  • “ANTI-INFLAMATORY PROPERTIES: Naturgin is…as effective as any pharmacy bought medicine.”
  • “ALLEVIATES COUGHING: Aloe Vera is one of the greatest solutions for treat children’s upset lungs as it reduces inflammatory proteins, helps expel phlegm….”

Under the “DIRECTIONS” section of your product webpage:

  • “Helps to avoid…pain of the throat”
  • “Take it from 1 to 3 times (teaspoonful) per day to maintain a clean throat and to avoid the flu”
  • “In case of flu, cough or throat pain take it every 2 hours until nuisance disappears”

Syrup for Adults Ginger and Honey
https://naturgin.com/product/ginger-honey-syrup-5-ounces-for-adults/

Under the “Description” section of your product webpage:

  • “This dietary supplement has a generous mix of honey and ginger that will clear your throat…alleviate digestive inflammation and diminish severe coughing.”
  • “While the honey is a millenary soother for sore throats for its various antimicrobial properties; ginger is known for being anti-inflammatory….”

Syrup for Adults Forte Ginger, Honey, and Aloe Vera
https://naturgin.com/product/ginger-honey-aloe-vera-forte-for-adults-150ml-5-fl-oz-for-a-healthythroat/

  • “Naturgin Syrup Forte is a cough syrup which has been formulated for people who are more exposed to the environment than others and therefore are at greater risk of being in contact with viruses or bacteria that could compromise their health.”

Under the “Description” section of your product webpage:

  • “This dietary supplement has a generous mix of honey, ginger and Aloe Vera that will clear your throat, alleviate digestive inflammation and diminish severe coughing.”
  • “While the honey is a millenary soother for sore throats for its various antimicrobial properties; ginger is known for being anti-inflammatory….”
  • “This version also has Aloe Vera, which is frequently used to stop acute coughing and has potent anti-bacterial properties that will prevent the re-growth of microorganisms.”

Under the “PROPERTIES” section of your product webpage:

  • “ALLEVIATES SORE THROATS: Naturgin has a generous amount of honey which will quickly reduce inflammation and soothe your respiratory system.”
  • “DIMINISHES PHLEGM: Naturgin’s contains a generous dose of ginger, which has been used for centuries as a natural decongestant and antihistamine.”
  • “ANTI-INFLAMATORY PROPERTIES: Naturgin is…as effective as any pharmacy bought medicine.”
  • “ALLEVIATES COUGHING: Aloe vera is one of the greatest solutions for treat children’s upset lungs as it reduces inflammatory proteins, helps expel phlegm….”
  • “REDUCES DIGESTIVE SYSTEM INFLAMATION: Ginger is also one of the greatest remedies for upset stomachs as it reduces inflammatory proteins and increases anti-inflammatory molecules that will alleviate stomachaches and prevent nausea.”

Under the “DIRECTIONS” section of your product webpage and the “Description” section for Combo #1 – Syrup for Adults Forte Ginger, Honey, and Aloe Vera and Vitamin C 1000 mg/caps:

  • “Helps…and pain of the throat”
  • “Take it from 2 to 3 times (Spoonful) per day to maintain a clean throat and to avoid the flu”
  • “In case of flu, cough or throat pain take it every 2 hours until nuisance disappears.”

AFA Blue Green Algae 1000 mg
https://naturgin.com/product/aphanizomenon-flos-aquae-1000mg-60-veggie-caps-x-500mg-each-30-servings/

  • “APHANIZOMENON FLOS AQUAE…anti-inflammatory….”

Magnesium Complex All in One Capsule Magnesium and Potassium
https://naturgin.com/product/magnesium-complex-90-capsules-x-460mg-magnesium-citrate-99mg-potassium-citrate-90-days-supply/

  • “Magnesium…prevents chronic headaches.”

Vitamin C 1000 mg/caps
https://naturgin.com/product/product/vitamin-c-1000mg-for-daily-immune-support-and-antioxidant-100-capsules/

  • “Support the immune system against virus and germs”
  • “Vitamin C stimulates antibody production to aid the immune system in reducing the severity and duration of colds”

Further, your social media website, https://www.facebook.com/photo/?fbid=2816687698585430&set=ecnf.100063623525475 also contains evidence of intended use of your products for the cure, mitigation, treatment, or prevention of disease. For example, your Facebook post on February 25, 2021, for Syrup for Adults Forte Ginger, Honey, and Aloe Vera states:

  • “Take it from 2 to 3 times (Spoonful) per day to maintain a clean throat and to avoid the flu.”
  • “Helps…pain of the throat.”
  • “In case of flu, cough or throat pain take it every 2 hours until nuisance disappears.

Your Syrup for Children Ginger, Honey, and Aloe Vera; Syrup for Adults Ginger and Honey; Syrup for Adults Forte Ginger, Honey, and Aloe Vera; AFA Blue Green Algae 1000 mg; Magnesium Complex All in One Capsule Magnesium and Potassium; and Vitamin C 1000 mg/caps 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 Syrup for Children Ginger, Honey, and Aloe Vera and Syrup for Adults Forte Ginger, Honey, and Aloe Vera products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, 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 Syrup for Children Ginger, Honey, and Aloe Vera and Syrup for Adults Forte Ginger, Honey, and Aloe Vera products 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 U.S. Food and Drug Administration, attention to: Mr. Ramon A. Hernandez, Program Division Director, 466 Ave. Fernández Juncos, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to the email address: orahafeast4firmresponses@fda.hhs.gov. If you have any questions regarding this letter, please contact, Ms. Gina Eng, Compliance Officer, at (954) 759-7715 or via email at Gina.Eng@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
Program Division Director
Office of Human and Animal Food Operations
East IV Division

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