Division of Human and Animal Food Operations West V
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
June 27, 2017
 
Dr. Carolyn Dean                                                                                           WL #525164-17
52 Kainui Loop
Kihei, HI 96753
 
Dear Dr. Dean:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.rnareset.com/ in May 2017 and has determined that you take orders there for the products ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium. The claims on your website and personal testimonials recommending or describing the use of the products establish that the 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 diagnosis, 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 and testimonials that provide evidence that your products are intended for use as drugs include:
 
ReMyte
ReAline
ReMag
ReStructure
ReCalcia® Pico Meter Calcium
ReMag & ReMyte
Your ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium 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)]. 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 ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium products are intended for treatment of one or more diseases that are not amendable 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, these 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 an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products for which you make claims on your website for intended uses that cause the products to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice, such as seizure and/or injunction.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.
 
You may respond in writing to:
 
Matthew Walburger, Acting Director
Compliance Branch
Food and Drug Administration
HAF Division West 5, HFR-PA1500
1431 Harbor Bay Parkway
Alameda, CA 94502
 
If you have any questions about the contents of this letter, please contact Ms. Sara Dent Acosta via email at sara.dent@fda.hhs.gov or by phone at (619) 941-3767.
 
Please reference CMS number 525164 in your response.
 
Sincerely,
/S/                                                                                                                                   
Darlene Almogela, Acting Division Director
Office of Human and Animal Foods
Division 5 West
US Food and Drug Administration
 
Cc:
David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435

This page was posted on April 30, 2019.

Links to Recommended Companies

  • PharmacyChecker.com: Compare drug prices and save money at verified online pharmacies.
  • ConsumerLab.com: Evaluates the quality of dietary supplement and herbal products.
  • Amazon.com: Discount prices, huge inventory, and superb customer service.
  • OnlyMyEmail: Award-winning anti-spam services.
  • 10 Types: Website design, development, and hosting with superb technical support.