Inspections, Compliance, Enforcement, and Criminal Investigations

New Capstone, Inc 6/27/17

 

  

Black HHS-Blue FDA Logo

 

 

 
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
  • “ReMyteTM includes Boron, Copper, Chromium, Iodine, Selenium, Zinc, all of which have very specific roles to play in . . . cancer protection . . ..”
  • “Boron [an ingredient in ReMyte] is being investigated as a treatment for the following conditions: congestive heart failure, high cholesterol, arthritis, gout, [and] osteoporosis . . .. Some people claim that it’s a near miraculous treatment for arthritis.”
  • “A zinc to copper imbalance, with too much copper and not enough zinc, can be a factor in postpartum-depression, . . .ADHD, psychosis, and paranoia . . .. ReMyte contains 15 times more zinc than copper, which will help treat excess copper in the body.”
  • “[C]opper deficiency and copper toxicity can both block copper function, resulting in hypothyroidism, decreased muscle function, and a sluggish brain. That’s why a small amount of bioavailable copper, found in ReMyte, is the treatment of choice for both copper deficiency and copper excess.”
  • “Acetaldehyde is a breakdown product of alcohol that is call the ‘hangover chemical.’ Guess what else produces acetaldehyde? Candida albicans. Therefore, if you have yeast overgrowth., the molybdenum in ReMyte will help break down toxic acetaldehyde . . ..”
  • “ . . . ReMyte contains . . . selenium . . .. The symptoms of selenium deficiency are quite generalized, to include hypothyroidism, impaired immune function, and blood sugar imbalance.”
  • “[A]fter about two months of taking ReMyte, I found that I didn’t need as much magnesium to keep from getting heart palpitations.”
ReAline
  • “[R]educes brain inflammation”
  • “[D]etoxification of mercury and other heavy metals”
  • “[D]etoxifying chemicals and heavy metals.”
  • “[T]o help reduce…depression”
  • “[T]o inhibit toxic metals from crossing the blood-brain barrier.”
ReMag
  • “[T]reats heart disease . . . muscle pain and spasms, nerve problems”
  • “[F]or local injury, arthritis, muscle pain or joint pain . . . for painful injuries”
  • “Magnesium [an ingredient in ReMag] helps prevent obesity genes from expressing themselves”
  • “Lack of these necessary energy nutrients [contained in ReMag] . . . lead[s] to such far ranging symptoms as hypoglycemia . . . and obesity.”
  • “[A]nti-inflammatory”
  • “When I began using the right type of magnesium, ReMag, I finally found relief for . . . heart palpitations, charley horses, insomnia, muscle twitching, low back pain, and neck pain”
  • “[Can be used by] people who suffer from IBS-diarrhea, Crohn’s, and colitis . . . without causing a laxative effect”
  • “[H]elp[s] solve many of the chronic disease problems”
  • “[F]or injury, pain, and arthritis”
  • “[F]or painful injuries”
  • “I used to have very specific magnesium deficiency symptoms (heart palpitations and severe Charlie horse, leg cramps) . . ..  I upped my intake of ReMag, causing all my symptoms to disappear.”
ReStructure
  • “ReStructure is . . . a meal replacement for controlling blood sugars in hypoglycemia, prediabetes, or diabetes.”
  • “[R]educing the risk of heart disease”
  • “Assists in lowering cholesterol”
  • “May reduce the risk of Macular Degeneration by lowering blood sugar and inflammation”
  • “Helps reduce the risk of Type 2 Diabetes”
  • “[T]he benefits of reducing inflammation throughout the body”
  • “[H]elp to lower blood pressure and cholesterol” 
ReCalcia® Pico Meter Calcium
  • “Vanadium is being studied in . . . heart disease.” 
ReMag & ReMyte
  • “One customer, after being on ReMag and ReMyte for several months, lowered her blood pressure from 180/95 to 110/60. Also, her ejection fraction improved to 60%, and her last ultrasound of her carotid artery showed a 30% to 40% lessening of calcified occlusions.”
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

 

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