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  5. Immune & Genetics Protocols, LLC - 611042 - 03/30/2021
  1. Warning Letters

WARNING LETTER

Immune & Genetics Protocols, LLC MARCS-CMS 611042 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
William Denizard-Flores
Recipient Title
Manager
Immune & Genetics Protocols, LLC

1655 SW 63rd ST RD
Ocala, FL 34476
United States

Issuing Office:
Office of Human and Animal Food Operations, East Division IV

United States

March 30, 2021

21-HAFE4-WL-04 / CMS No. 611042

Dear Mr. Denizard-Flores:

This is to advise you that in March 2021, the United States Food and Drug Administration (FDA) reviewed your website at https://www.biogreencell.com from which you take orders for the product Immune Bio Green Cell. We also reviewed your social media website at https://www.facebook.com/BioGreenCell/, which directs consumers to your website, https://www.biogreencell.com, to purchase your product.

The claims on your website establish that Immune Bio Green Cell is a drug under section 201(g)(1)(B) of the Food, Drug, Cosmetic Act (the Act), [21 U.S.C 321(g)(1)(B)] because it is intended for the use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links in FDA's homepage at www.fda.gov.

Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:

On your webpage www.biogreencell.com:
• “Immune Bio Green Cell . . . . By modulating your immune system . . . it would have the ability to fight and could help your immune system attack malignant cells while preventing your immune system from attacking and / or destroying good cells.”

• “Pathology: Autism
Immune Bio Green Cell may help due to its composition promoting the restoration of the neuronal synapse.”

• “Pathology: Asperger [sic]
Immune Bio Green Cell may help due to its composition promoting the restoration of the neuronal synapse.”

• “Pathology: Diabetes Type 2
The active principle of Immune Bio Green Cell, is to activate the regeneration of the pancreatic cells so that these can produce sufficient insulin; hence, regulating blood levels.”

• “Integrative with Chemotherapy and Radiotherapy
Immune Bio Green Cell could relieve and reduce side effects by strengthening your immune system.”

• “Pathology: Crohn [sic]
Immune Bio Green Cell could help you to have your immune system stopped [sic] attacking your own cells, thereby helping to deflate the parts of the gastrointestinal tract, thus returning cellular genetic recognition to your immune system.”

• “Pathologies: Renal, Liver and Spleen
Immune Bio Green Cell is an immunomodulator that could return cellular genetic recognition to your immune system to act as a defensive mechanism on malignant cells.”

On your Facebook page at https://www.facebook.com/BioGreenCell/:
• Posted on February 20, 2018: “Some of the highly complex conditions that may benefit from its [Immune Bio Green Cell’s] use are:
    o Cancer – All kinds
    o Lupus
    o Leukemia
    o HIV and AIDS
    o Tumors
    o Rheumatoid arthritis
    o Epidermolysis Bullosa
    o Psoriasis
    o Pulmonary hypertension
    o Multiple sclerosis”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Immune Bio Green Cell for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your webpage www.biogreencell.com:
• “I was diagnosed with a progressive condition in my immune system . . . I never imagined the power and the reach so great that Immune Bio Green Cell could have. My tumor markers were reduced almost miraculously.”

• “Its [Immune Bio Green Cell’s] ability to potentially help the immune system exercise its functions optimally, makes it the ideal choice for use as a preventive or as an adjunct treatment for chronic diseases . . .”

Your Immune Bio Green Cell product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 Immune Bio Green Cell product is 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 purposes. Accordingly, the product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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.

In addition, we offer the following comment:

• On your About Us webpage at https://www.biogreencell.com/aboutus.asp you state that “Immune Bio Green Cell is a product approved as Immune System Enhancement Formula by USDA and is made in a laboratory registered with the FDA.” The About section of your Facebook page for Immune Bio Green Cell at https://www.facebook.com/BioGreenCell/ states “Approved for sale by the ‘USDA’. Manufactured and packaged in laboratory approved by the ‘FDA’ in the United States”. We note that the United States Department of Agriculture (USDA) does not approve drugs or dietary supplements. We do not have any records that your facility is registered with FDA. Your Immune Bio Green Cell product appears to be labeled as a dietary supplement. Under section 201(ff) of the Act (21 U.S.C. § 321(ff)), a dietary supplement and a component of a dietary supplement are “foods.” Section 415 of the Act (21 U.S.C. § 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA unless the facility qualifies for an exemption from registration (21 CFR 1.226).

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 directed to Mr. Ramon Hernandez, Acting District Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Pearl Lopina, Compliance Officer, at (407) 475-4730 or pearl.lopina@fda.hhs.gov.

Sincerely,
/S/

Director San Juan District and Program Director
Office of Human and Animal Food Operations,
East Division IV

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