Nature Cast Products 7/15/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District|
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
July 15, 2013
934 N. University Dr. #291
Coral Springs, FL 33071
Dear Mr. Berman:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.naturecastproducts.com, in April 2013 and has determined that your products Eradicator and Nature’s Gold are promoted for the treatment of diabetes, which causes these products to be 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)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.
Examples of the claims observed on your website include the following:
On the product page for “Eradicator”:
Under the heading “Introducing Eradicator!”:
• “It eradicates the causes of uncontrolled blood sugar by packing your system with all natural, proven and biochemically powerful nutrients that regulate your blood sugar levels….”
• “Chromium helps regulate blood sugar levels by collaborating with insulin in facilitating the uptake of glucose into the cells. If chromium is not present, insulin’s action is blocked and blood sugar levels are elevated. Insulin is secreted in response to the rise in blood glucose levels after the consumption of a meal. Insulin functions by increasing the rate that glucose is taken up by the cells and the [sic] lowers blood glucose levels.”
• “Fenugreek Seed: … Several human intervention trials demonstrated … the blood sugar reduction effects of fenugreek seeds. In a study conducted by the National Institute of Nutrition subjects were give [sic] the seeds in their diet. The fenugreek diet significantly reduced fasting blood sugar and improved the glucose tolerance test. There was a 54 per cent reduction in 24-h urinary glucose excretion. Serum total cholesterol, LDL and VLDL cholesterol … were also significantly reduced.”
• “Cinnamon Bark: … [A]nother study, Effects of a Cinnamon Extract on Plasma Glucose, HbA, and Serum Lipids in Diabetes Mellitus Type 2, concluded that cinnamon extract appears to have a moderate effect in reducing fasting blood sugar concentrations.”
• “Pysillium [sic] Seed: … Recent research shows psyllium seeds to be promising in … controlling diabetes. … It has been shown in studies [to] lower blood glucose levels from 14-20%.”
On the product page for “Nature’s Gold”:
• “According to the Center for Disease Control, in the United States, Diabetes is the 6th largest killer and experts say that inflammation plays a big role in the risk of developing this illness. … Nature’s Gold has been carefully tested and formulated to deliver to your body an arsenal of potent natural weapons to help your body reduce inflammation. Take a look at this war chest of inflammation fighters.”
• “Grape seed extract contains polyphenols which have been shown in clinical studies to exhibit anti-inflammatory activity. … For example in a study conducted by the University of Rovira, in Spain, researchers concluded that Grape Seed Extract demonstrates a potential health benefit in inflammatory conditions…. ”
• “Quercetin acts as an anti-inflammatory, and may help protect against heart trouble and cancer. Quercetin can also help stabilize the cells that release histamine in the body and thereby have an anti-inflammatory effect.”
• “Beta-Glucan: In a study conducted at the University UFRN located in Brazil, researchers concluded that the glucan has anti-inflammatory properties that are a result of the inhibition of … cyclooxygenase (COX). ”
• “Red Raspberry Juice Extract: Researchers … reported that the anti-inflammatory activity was attributed to the down-regulation of IL-6, IL-1¦Â [sic] and TNF-¦Á [sic] levels as well as gene expression of iNOS and COX-2 through the suppression of NF-¦ÊB [sic] activation, and induction of anti-inflammatory cytokine IL-10 and anti-inflammatory mediator HO-1.”
• “Ellagic Acid: A study conducted by the American Association of Nurse Anesthetists Foundation concluded: ‘Our findings suggest that ellagic acid may be effective against inflammation … and may interact with known cyclooxygenase inhibitors.’”
• “You won’t be able to find another product like Nature’s Gold on the marketplace … I’m talking about a powerhouse of natural substances that will help your body stop creating so much inflammation ….”
• “Reduced inflammation can … potentially reduce your risk of suffering heart problems, stroke, cancer, [or] diabetes …. I can’t think of anything better you can do for yourself than to give yourself the anti-inflammatory benefits of Nature’s Gold.”
Your products Eradicator and Nature’s Gold are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, Eradicator and Nature’s Gold are offered for diabetes, a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited in this letter are not meant 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 and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing as to the specific steps 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 corrections.
Please send your reply to the attention of Andrea H. Norwood, Compliance Officer, Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding this letter, please contact Ms. Norwood at 407-475-4724.
Emma R. Singleton
Director, Florida District