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  5. Renewal Supplements LLC - 608749 - 08/25/2020
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WARNING LETTER

Renewal Supplements LLC MARCS-CMS 608749 —

Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Vincent Manzo
Renewal Supplements LLC

135 Weston Road, Suite 138
Weston, FL 33326
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

WARNING LETTER

August 25, 2020

RE: 608749

Dear Mr. Manzo:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.opi-cure.com in June 2020 and has determined that you take orders there for the product “Opi-Cure.” The claims on your website 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 the image of your product label:

  • The name of your product, “Opi-Cure”
  • “Relieves withdrawal symptoms associated with opiate abuse”

On your home page:

  • “Opi-Cure is a unique supplement that contains root bark of the voacanga magnitola (voacanga africana) tree that contains the alkaloids voacangine and voaccamine which has been shown to be effective in the treatment of withdrawal symptoms and cravings associated with opiate dependence.”
  • “Opi-Cure [with check marks]:

    o Muscle Aches
    o Restlessness
    o Anxiety
    o Sweating
    o Diarrhea
    o Nausea”

  • “REAL WITHDRAWAL RELIEF Opi-Cure will help eliminate or reduce the severe, sometimes flu-like, symptoms that are known as Opioid Withdrawal Syndrome (OWS).”
  • “WHAT IS OPIOID WITHDRAWAL SYNDROME? Stopping opioid use can result in severe, sometimes flu-like, symptoms that are known as Opioid Withdrawal Syndrome (OWS).”
  • “NO PRESCRIPTION REQUIRED Opi-Cure is considered a dietary supplement to help relieve the flu-like withdrawal symptoms so no prescription is required.”

On the product page for “Opi-Cure”:

  • “Opi-Cure's primarily [sic] use is as a supplement to aid the cessation of opiate or stimulant use in persons with addiction by providing relief from the severe, sometimes flu-like symptoms caused by Opioid Withdrawal Syndrome (OWS). It can also be used to assist in breaking the cycle of abuse and relapse after the initial detoxifying process is complete.”

On your webpage titled “Opi-Cure Usage Strategies”:

  • “For those with a low to moderate opiate dependency, Opi-Cure is best suited for going cold turkey off of moderate opiate dosage. If this fits your opiate use profile, independent treatment with Opi-Cure as directed when you start feeling your withdrawal symptoms should keep the withdrawals at bay. After a few days, your withdrawal symptoms should start to subside and you can gradually reduce Opi-Cure dosages and frequency.”
  • “For those with a high opiate dependency and history, Opi-Cure is best used for a week or two to lower that dependency. For example, this can be done by skipping doses or cutting your dose in half while simultaneously using Opi-Cure to relieve the resulting withdrawals and effects of skipping or reducing a highly addictive substance. Opi-Cure will help your brain regulate to the lower dose much faster than normal.”
  • “Once you believe your dosage has reached a point to consider it a LOW TO MODERATE OPIATE DEPENDENCY, then you would be in a position where you could remove opiates cold turkey (as described above) and Opi-Cure would be effective. This method takes a little bit of discipline but can be adjusted to a speed you feel comfortable with.”

On your webpage titled “FAQ”:

  • “Opi-Cure is a unique supplement that is effective in the treatment of withdrawal symptoms and cravings associated with opiate dependence.”
  • “Opi-Cure is for those suffering from the physical and mental dependence that addiction brings also known as Opioid Withdrawal Syndrome (OWS).”
  • “The chemical structure of voacangine and voaccamine resembles ibogaine, found in the Iboga shrub native to Central Africa that has an ‘anti-addiction’ effect. The voacangine and voaccamine found in Opi-Cure has been proven to possess the same effects therefore, is effective in the treatment of withdrawal symptoms and cravings associated with opiate dependence.”
  • “Opi-Cure should be taken as soon as you start feeling your withdrawal symptoms.”
  • “Opi-Cure dosage varies greatly by your current opiate use and dependency. Therefore, we recommend beginning treatment with 2-3 capsules with food every 4-5 hours. For customers who need additional relief, Opi-Cure can be taken in a higher dose (4-5 capsules) and more often (every 2-3 hours) based on your own relief requirements but only AFTER initial individual response has been effectively judged. For moderate opiate/stimulant addiction, at least two bottles is recommended.”

Your 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)]. 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 “Opi-Cure” 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, “Opi-Cure” 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)].

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 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 by email to Mr. Shawn Goldman at FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 
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