USA FDA Attacks Nature’s Pearl On Health Claims
Nature's Pearl Corporation 4/19/12
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Public Health Service Food and Drug Administration |
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Atlanta District Office |
Department of Health and Human ServicesApril 19, 2012
VIA UNITED PARCEL SERVICE
WARNING LETTER
(12-ATL-11)
Jerry W Smith, CEO
Nature's Pearl Corporation
3134 Cornatzer Road
Advance, NC 27006
Dear Mr. Smith:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.naturespearlproducts.com in December 2011 and has determined that your Nature's Pearl™ Premium Muscadine Grape Seed Supplement product is promoted for conditions that cause the product to be 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)]. The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your website include:
Under the tab, Science and on the webpage titled, Human Clinical Trials:
• Inhibition of Cancer Cell Growth by Muscadine Grape Seed & Muscadine Grape Skin Extracts
• These results demonstrate that extracts from muscadine grape seeds and muscadine grape skins inhibit the growth of human lung, colon, prostate, breast, skin , brain and leukemia cells in vitro, suggesting that further studies are warranted to investigate their potential use in the prevention or treatment of cancer.
Under the tab, Science and on the webpage titled News Articles:
• The chemical· constituents of muscadine grapes … have shown several antitumor effects.
Further, the News Articles webpage on your website lists research and articles about the usefulness of the ingredient grape seeds in treating or preventing diseases.
When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following are examples of reference citations used to market your Nature's Pearl™ Premium Muscadine Grape Seed Supplement for disease treatment and prevention on your website:
• Unique Grape Seed Extract Inhibits Prostate Cancer Cell Growth in the Laboratory. U.S. National Institute of Health, September 1, 2007.
• Grape Seed Extract Kills Laboratory Leukemia Cells. ScienceDaily, January 1, 2009.
• Effect of Muscadine Grape Seed Supplementation on Vascular Function in Subjects with or at Risk for Cardiovascular Disease: A Randomized Crossover Trial. J Am Coli Nutr October 2010 vol. 29 no. 5 469-475
• Inhibition of cancer growth by muscadine grade (sic) seed and grape skin extracts. Wake Forest University Health Sciences' presentation at 2011 AACR Meeting, Orlando, Florida, April 5, 2011.
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 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, your product is offered for conditions that are 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, your product is 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.
Further, your website also makes the following statement: Nature's Pearl™ has been certified by the FDA to be in Full Compliance under FDA 21 CFR 111. This statement is false and misleading under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)) because FDA does not certify compliance with the dietary supplement current good manufacturing practices under 21 CFR Part 111.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Marie Mathews, Compliance Officer, Food and Drug Administration, at the address in the letterhead above. If you have any questions regarding any issue in this letter, please contact Ms. Mathews at 404-253-1279 .
Sincerely,
/S/
John R. Gridley, Director
Atlanta District
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I hardly call this an attack. Asking them to make corrections is no attack. I’ve had products approved by the FDA before. This is merely a compliance issue.
I am not associated with Nature’s Pearl but let me say this. What kind of a post is this suppose to be and suppose to serve for the Network Marketing industry. You are like some parasite not dissimilar to the corrupt news network in the USA that will print anything just for the sensationalism to drive traffic to your site. Please tell me what you are trying to prove and what is the mandate of this site? Posts like this without an ethical investigative review prior to posting in my opinion is criminal and as Harold mentions, “hardly an attack”. Do you think you are doing the industry a favor by posting this? If you ask me there is one motif behind this and that is to serve your own personal agenda and nothing else. I am disgusted that you call yourself a news reporting source for the industry especially when you have figured out a crafty way to make sure you show up on the first page of a web search. Shame on you and shame on what this web site represents. Its all fluff and anyone who can’t see through your evil ways is as blind as you are.
In response to this letter from the FDA, here is some factual evidence that supports the content and statements on the Nature’s Pearl website.
1) The “human clinical trials” are available for anyone to read and all of the links to these trials can be easily found on my website at https://www.chs365.com/content/natures-pearl-premium-muscadine-grape-products
2) The definition of a drug as listed on dictionary.com states the following:
drug1 ? ?[druhg] Show IPA noun, verb, drugged, drug·ging.
noun
1. Pharmacology: a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being.
2. (in federal law)
a. any substance recognized in the official pharmacopoeia or formulary of the nation.
b. any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.
c. any article, other than food, intended to affect the structure or any function of the body of humans or other animals.
d. any substance intended for use as a component of such a drug, but not a device or a part of a device.
***Notice that within the federal law guidelines, 2c states a drug is “any article, OTHER THAN FOOD” by definition.***
Wikipedia.org defines a Muscadine as the following: a grape, Vitis rotundifolia, of the southern U.S., having dull purple, thick-skinned musky fruit and being the origin of many grape varieties.
Since a grape is a fruit, which is incontestably food that exists genuinely in nature, the fact that the FDA can abruptly deem it a drug based on it’s health benefits proven by credible scientific research, is disconcerting.
3) There are, and always have been, dosage instructions and supplement facts on the side of every Nature’s Pearl bottle, which state: As a dietary supplement for adults, take 2 capsules per day. Children as directed by a physician. No alcohol or chemical extractions were used. Contains NO artificial colors or additives. Keep out of reach of children. DO NOT USE if seal is broken or damaged. Store in a cool, dry location. These statements have not been evaluated by the US Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
4) According to the FDA website, 21 CFR Part 111 “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements” states that the FDA DOES certify the manufacturing practice for dietary supplements. In addition, a copy of the certification letter from the FDA to Nature’s Pearl can be found on the Nature’s Pearl site under “Introduction > Media Resources > Media Kit Contents > About Nature’s Pearl” and is dated March 9, 2010.
In addition to these facts negating the contents of this FDA Warning letter, I have personally been taking Nature’s Pearl on a daily basis since October of 2011. I am very much a skeptic and do all of my research before getting involved with any company, especially declaring to have amazing health benefits such as these. I have personally seen positive results myself, specifically with my allergies, which have improved tremendously with all other variables in my life remaining constant. I have also been a live-in caretaker to two patients with cancer and have watched each of them suffer through numerous, unsuccessful chemotherapy treatments. When you’re in the situation of life and death due to cancer, you are willing to try anything to regain your health. The fact that a fruit, such as this, bears these conciliating traits, is a blessing and should be shared with the world. To date, I am unaware of any adverse reactions to this product and as always, it is wise to consult a physician before taking any supplement in order to prevent any negative interactions.
Well said Chester! What a bunch of bull. I hate MLM Blogs and self righteous companies who make all kinds of claims with no research.. YOU finally get one doing things right, doing clinical trials on their own product and they get persecuted. I have done some research and everyone should read and applaud this company. What on earth is our government thinking when you have a product, created by the CREATOR that helps people with no side effects and we want to criticize them. The FDA is the same group that approved VIOXX and other drugs that kill people. They should be ashamed of themselves for this double standard.
Folks, it is time for people to stand up in America and be counted. Read these trials and decide for yourselves:
The company has completed the first randomized, double-blind, placebo-controlled, crossover human clinical trial researching the company efficacy on cardiovascular function (published in Journal of American College of Nutrition, October, 2010). This is the only muscadine company in the world to conduct human clinical trials on its products.
Other Resources:
Wake Forest Baptist Health Research Report on Cardiovascular Trial on Muscadines https://www.wakehealth.edu/Clinical-Trials/Muscadine-Grape-Seed-Supplementation- and-Vascular-Function.htm
Muscadine Grapes Show Prostate Cancer Inhibition of Growth https://www.ncbi.nlm.nih.gov/pubmed?term=muscadine%20grapes%20prostate%20cancer
Apoptosis in Human Colon Carcinoma from Muscadine Grapes https://www.ncbi.nlm.nih.gov/pubmed/16848514
Anticancer Activities of Muscadine Grapes https://www.ncbi.nlm.nih.gov/pubmed/16248588
Muscadine Polyphenols Induce Apoptosis in Human Leukemia Cells https://www.ncbi.nlm.nih.gov/pubmed/15670891
WHAT THE FDA IS DOING HERE IS REALLY GIVING GOOD POSITIVE ATTENTION TO A GREAT LITTLE COMPANY. Think about it, these products are all natural, what is our country coming to folks? Stand up and be counted!
I am so angry that I am calling THIS COMPANY TODAY to get these amazing products. THEY COULD NOT BE ANY WORSE THAN SOME OF THE PRODUCTS APPROVED BY OUR WONDERFuL FDA. HECK, I AM WRITING ALL OF MY CONGRESSMEN AND SENATORS, TOO. This letter is a crying shame!
There is a brighter side of this letter. This shows that this is the only company in MLM history who has done human clinical trials. There are many MLM names where reps know that their products do not have any significant benifits but still they are promoting them.
This company just a start up company, less than a year in USA and only few months in Canada. Just launched Guam and next is Philippines. It has created such a big buzz in MLM world with an unique compensation plan that it has scared many big names. I invite all big MLM leaders to compare their comp plan openly on this platform.