WARNING LETTER
Biorica International Corp.
MARCS-CMS 659194 —
August 04, 2023
Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Jacqueline Baxas
Recipient Title
President
Biorica International Corp.
4310 Sheridan St., Suite 202
Hollywood
,
FL
33021
United States
info@biorica.biz
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
August 4, 2023
RE: 659194
Dear Jacqueline Baxas:
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://www.plaquex.com/, https://biorica.biz/en/, https://www.facebook.com/www.biorica.biz/, and https://www.facebook.com/people/Plaquex/100063669775556/ in May 2023 and has determined that you take orders there for the product Plaquex® Oral Dietary Supplement. Your websites at https://www.plaquex.com/ and https://www.facebook.com/www.biorica.biz/ direct customers to your website https://biorica.biz/en/, to purchase your product Plaquex® Oral Dietary Supplement. Your website https://www.facebook.com/people/Plaquex/100063669775556/ directs customers to your website https://www.plaquex.com/, which then directs customers to your website https://biorica.biz/en/ to purchase your product.
The claims on your websites establish that the product is a drug 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 it is intended for 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 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 product is intended for use as a drug include:
On your website https://www.plaquex.com/:
“In 2006 Plaquex® Oral Gel Capsules were added to the treatment regimen. They improve blood lipids and liver and kidney function and thereby aid in the prevention of plaque deposits in between IV treatment sessions and after the infusion series is completed.”
On your website https://biorica.biz/en/:
“Plaquex Oral is indicated for lowering cholesterol levels, triglyceride levels and to improve liver function but also as a[n] additional treatment to Plaquex infusions to prevent re-formation of plaque in the blood vessels after removal. Plaquex Oral is also used in kidney disease as studies show that it increases creatinine and urea clearance in conjunction with Plaquex infusions. Studies in patients with Psoriasis and Neurodermitis show that skin manifestations recede faster and stay in remission longer than with placebo.”
On your Facebook social media website at https://www.facebook.com/people/Plaquex/100063669775556/:
On your Facebook home page: “A revived treatment to prevent heart attack, stroke, amputations and other nasty things like liver a [sic]”
In a July 31, 2017 post: “Can Plaquex® help prevent cancer?...Conclusion…In conclusion we can surmise that supplying phospholipids of the kind used in Plaquex® improves cell membrane function including the function of Sodium-potassium ATPase, and thus helps to maintain negative voltage in the cell preventing dedifferentiation of the cell into cancer cells. As the title says, this is only a thought experiment. Retrospective studies need to be done with patients doing Plaquex® therapy over a long period of time and comparing their rate of new cancers to the rate of a matched control group.”
In a July 29, 2017 post: “Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.”
On your Facebook social media website at https://www.facebook.com/www.biorica.biz/:
In a August 19, 2016 post: “Stop buying lecithin and generic phosphatidylcholine products. Most will do more harm than good and actually increase plaque build-up in your arteries and cause fatty liver disease…You can help your body heal itself. Plaquex® Oral is a beautiful way to do just that…Imagine visiting your doctor one day as he smiles and says “Your cholesterol is back to normal!”…Plaquex® Oral can give you all this and more.”
Your Plaquex® Oral Dietary Supplement is not generally recognized as safe and effective for the above referenced uses and, therefore, it 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 product Plaquex® Oral Dietary Supplement 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, Plaquex® Oral Dietary Supplement 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.
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 response should be sent to the United States Food and Drug Administration at CFSANResponse@fda.hhs.gov. Please include “CMS 659194” in the subject line of your email.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
11/07/2023
Regulated Product(s)
Dietary Supplements
Food & Beverages