• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Royal Domains 1/6/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161 

January 6, 2012

VIA UNITED PARCEL SERVICE

WARNING LETTER
(12-ATL-05)

 


Royal Domains
Attn: Rick Irving
14309 Blue Granite Rd.
Pineville, North Carolina 28134


Dear Mr. Irving:

The U.S. Food and Drug Administration (FDA) reviewed your website at www.itsnaturespearl.com in December 2011 and has determined that your "Nature's Pearl Premium Muscadine Grape Seed" dietary 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 your product with these claims violates the Act.


In addition, our review of your product labeling revealed that your "Nature's Pearl Premium Muscadine Grape Seed" dietary supplement product, as described further below, is in violation of the Act and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR 101.


You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.


Unapproved New Drug


Examples of some of the claims observed on your website include:


On your home page, under the heading "Nature's Pearl and Cancer'':


• "Laboratory tests done by Wake Forest University show Nature's Pearl inhibiting the growth of 7 different cancers!"


• "Resveratrol [found in product] ... has been reported to have anti-inflammatory as well as anticancer poperties [sic]. Resveratrol, may counter type 2 diabetes and insulin resistance .... "


• "[R]esearchers . . . found various grape extracts . .. to be effective at inhibiting Helicobacter pylori, one of the leading causes of gastritis in humans."


On your webpage entitled "Nature's Pearl Fact Sheet":


• "Wake Forest University Health Sciences research discovered the seeds and skins extract significantly inhibited the growth of 7 different types of cancer (breast 92.6%/ colon 80.5%/ brain 90.2%/ skin 60.9%/ leukemia 74.2%/ prostate 80.4%/ lung 81.8%)"

• "[']Inhibition of Cancer Cell Growth by Muscadine Grape Seed and Grape Skin Extracts' ... "


• '"Muscadines may be the way we protect ourselves from cancer."'


In a news video featured on the home page which includes the President of Nature's Pearl, Brock Agee:


• "It [muscadine grapes] has been called the new way to prevent cancer .... "


• "[H]ow doctors hope to stop cancer, one muscadine at a time."


• "According to some doctors, the secret to beating cancer."


• "[N]atural chemicals found in muscadines can help prevent cancers before they start."


• "[I]t [muscadine grapes] can help people with a disease as terrible as cancer."


Your website also includes claims in the form of personal testimonials. For example:


From your webpage entitled "Nature's Pearl Testimonies"


• "My son asked me to try this product for my arthritis .... In seven days the arthritis in my hands was gone. This is truly a miracle!"


• "I had a heart attack ... and was placed on blood pressure medication and could not work or do anything strenuous. I had been on the medication for months with no results. I asked my doctor about Nature's Pearl but he was not familiar with it and seemed not interested. I started taking Nature's Pearl and after taking NP supplement for two months my blood pressure became perfect, WOW ...."


From your webpage entitled "Doctor's [sic] and Nutritionists recommend Nature's Pearl™"
 


• "I have patients who are responding [sic] positively to a variety of problems by using Nature's Pearl Muscadine grape seed supplement. The powerful ... anti-inflammatory properties are beneficial in numerous medical problems."


Your home page contains links to other websites that bear claims that establish the intended use of your product as a drug. For example, On the website  http://www.daviecountyblog.com/?p=2336 which is accessed by clicking on the text "American Association of Cancer Research abstract" and "See Conference Article" on your home page:


• "[T]he anti-cancer properties of products from ... Nature's Pearl .... "


• "Muscadine Extracts From Nature's Pearl Show Promise For The Treatment and Prevention of Cancer''


On the website http://voices.yahoo.com/muscadine-grapes-show-potential-treat prostate-523325.html which is accessed by clicking on the text "muscadines and cancer" on your home page:


• "[T]he skin of muscadine grapes has the ability to slow down the growth of prostate cancer cells in laboratory experiments."


• "The results show that ... both resveratrol and muscadine grape skin extract have anti cancer properties ...."


The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. These metatags include "cancer prevention," "cancer cure," "cancer," and "cancer research."


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 this drug safely for its intended purpose. 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. 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)].


Misbranded Dietary Supplement


In addition, even if your "Nature's Pearl Premium Muscadine Grape Seed" product were not an unapproved new drug, it would still be a misbranded dietary supplement within the meaning of section 403 of the Act [21 U.S.C. § 343). 


Your "Nature's Pearl Premium Muscadine Grape Seed" dietary supplement product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because your home page states, "Nature's Pearl™ has been certified by the FDA," and your "Nature's Pearl Fact Sheet" states, "Nature's Pearl™ has been certified by the FDA to be in Full Compliance under FDA 21 CFR 111." These statements are false and misleading because FDA does not certify dietary supplements.


Your "Nature's Pearl Premium Muscadine Grape Seed" dietary supplement product is also misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)) because the labeling bears nutrient content claims that are not authorized by regulation. Under section 403(r)(2)(A)(i) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (and, by delegation, FDA) authorizing the use of such a claim. The use of a term, not defined by regulation, in food labeling to characterize the level of a nutrient of the type required to be in the labeling misbrands the food under section 403(r)(1)(A) of the Act.


Specifically, your home page bears the claim, "Nature's Pearl Contains The Highest Level's [sic] of Natural Antioxidants ... " This is a nutrient content claim subject to section 403(r)(1)(A) of the Act because it characterizes the level of a nutrient of a type required to be in the labeling of food (antioxidants) by using the term "the highest level." Under section 403(r)(2)(A)(i) of the Act, a nutrient content claim may be made only if the characterization of the level made in the claim uses terms which are defined by regulation. However, FDA has not defined the term "the highest level's [sic]" by regulation. Therefore, this term may not be used in nutrient content claims.


In addition, nutrient content claims using the term "antioxidant" must meet the requirements in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim (21 CFR 101.54(g)(1)), and these nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2)). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) (21 CFR 101.54(g)(3)). For example, to bear the claim "high in antioxidant vitamin C," the product must contain 20 percent or more of the RDI for vitamin C under 21 CFR 101.54(b). Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity (21 CFR 101.54(g)(4)). However, your nutrient content claim, "Nature's Pearl Contains The Highest Level's [sic] of Natural Antioxidants ... "does not comply with 21 CFR 1 01.54(g)(4) because it does not include the nutrients that are the subject of the claim or use a symbol to link the term "antioxidants" to those nutrients.


The above violations are not meant to be an all-inclusive list of violations that exist in connection with 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 described above and prevent their future recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and 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 within fifteen days, please explain the reason for the delay and state the date by which the corrections will be completed.


Please send your written response to the attention of Marie Mathews, Compliance Officer, Food and Drug Administration, 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions regarding any issues in this letter, please contact Ms. Marie Mathews at (404) 253-1279.

 

Sincerely,

/S/
John R. Gridley
Atlanta District Office
District Director