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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Crop Pharms 5/24/13

  

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

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Avenue
Jamaica, NY 11433 

 

May 24, 2013
 
WARNING LETTER NYK-2013-19
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Greg H. Quinn, President
Crop Pharms
59 Walnut Lane
Staatsburg, NY 12580
                              
Dear Mr. Quinn:
 
The U.S. Food and Drug Administration (FDA) inspected your facility located at 59 Walnut Lane, Staatsburg, New York from October 9 through 10, 2012, and on April 16, 2013. During these inspections we collected labels for your food product CurrantC™ Black Currant Nectar. We also reviewed your website at www.currantc.com in April 2013.  Based on our review of your website, we have concluded that your CurrantC™ Black Currant Nectar, CurrantC™ All Natural Black Currant Concentrate, CurrantC™ Genuine Dried Black Currants, 100% Pure Black Currant leaves, and CurrantC™ Black Currant Syrup products are in violation of sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 355(a), and 352(f)(1)].  In addition, based on our review of your labels, we have also concluded that your CurrantC™ Black Currant Nectar product is in violation of section 403 of the Act [21 U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links in FDA’s website at www.fda.gov.
 
Unapproved New Drugs
 
FDA reviewed your website at the internet address, www.currantc.com and has determined that your CurrantC™ Black Currant Nectar, CurrantC™ All Natural Black Currant Concentrate, CurrantC™ Genuine Dried Black Currants, 100% Pure Black Currant leaves, and CurrantC™ Black Currant Syrup products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims for black currants on your website establish that these black currant products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims violates the Act.
 
Examples of some of the claims found on your website include:
 
  • “[E]xciting new study shows great promise in the value of the predominant antioxidant in Black Currants, anthocyanin, to prevent liver cancer…”
 
  • “Two powerful compounds found in concentrated amounts in Black Currants may help protect our brains against diseases of aging. Preliminary research from the Harticulture and Food Research Institute in New Zealand found that the anthocyanins and polyphenolics found in Black Currants may help protect against Alzheimer’s disease.”
 
  • “In particular, berries like Black Currants that are especially high in certain compounds like flavonoids and other antioxidants may have an even more protective effect. A recent study in the American Journal of Clinical Nutrition found that subjects who were given a mixture of berries daily (including Black Currants) had a reduction in blood pressure and an increase in good (HDL) cholesterol, two factors that can decrease the risk of cardiovascular disease like heart attack and stroke.”
  
  • “Research and clinical studies have shown that certain antioxidants like vitamin C and anthocyanosides (anthocyanins) may…decrease the risk of age related vision problems such as cataracts and (AMD).”
 
  • “[A]nthocyanins and quercitin (found in Black Currants), may play a role in decreasing the degenerations of the macula (the part of your retina that’s responsible for central vision) by keeping harmful free radicals from damaging the retina.”
 
  • “While the best treatment for urinary tract infection is antibiotics, plant compounds called proanthocyanins, found in fruits like Black Currants, may help prevent the infection from beginning or progressing. Proanthocyanins work their magic by preventing harmful bacteria from sticking to the urinary tract walls.”
 
  • “Research is still sparse regarding Black Currant juice's support in the treatment and prevention of uric acid stone disease. But, it looks promising, according to findings published in the European Journal of Clinical Nutrition that report that subjects who drank Black Currant juice daily had a higher urinary pH and excreted more citric acid and oxalic acid. High levels of oxalic acid are associated with uric acid stone disease because the acid binds with metal ions in the body to deposit crystals which can irritate the kidneys. Black Currant juice shows promise for helping increase the excretion of oxalic acid.”
 
Your CurrantC™ Black Currant Nectar, CurrantC™ All Natural Black Currant Concentrate, CurrantC™ Genuine Dried Black Currants, 100% Pure Black Currant leaves, and CurrantC™ Black Currant Syrup 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 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 products are 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 the products safely for its intended uses. Thus, your 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 § 301(a) of the Act [21 U.S.C. § 331(a)].
 
Misbranding and Registration Violations
 
Your CurrantC™ Black Currant Nectar product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the label bears a nutrient content claim but does not meet the requirements to make the claim. Specifically, your label bears the nutrient content claims, “Black Currants have twice the antioxidants of Blueberries” and “…these anti-oxidant rich berries…” Under section 403(r)(l)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l)(A) of the Act.
 
Nutrient content claims using the term “antioxidant” must comply with the requirements listed 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 “rich 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)). The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(2)(A)(i) of the Act [21 U.S.C. § 343(r)(2)(A)(i)].
 
The nutrient content claim for your CurrantC™ Black Currant Nectar product of “Black Currants have twice the antioxidants of Blueberries” does not include the names of the nutrients that are the subject of the claim as part of the claim, or use a symbol to link the term “antioxidant” to a symbol that appears elsewhere on the same panel of the product label followed by the names of the nutrients, as required by 21 CFR 101.54(g)(4). Therefore, the claim “Black Currants have twice the antioxidants of Blueberries” does not meet the requirements of 21 CFR 101.54(g) and misbrands your product under section 403(r)(1)(A)(i) of the Act.
 
During the April 16, 2013, inspection, you told our investigator that you intend to modify this claim by placing an asterisk after the word “antioxidant” on the label and listing the particular antioxidants that are the subject of the claim. However, you said that you would not modify the label for two to three months. In addition, we have not received any documentation from you to support your assertion that you intend to modify the claim, such as updated labeling. We urge you to promptly revise the label of your CurrantC™ Black Currant Nectar product so that it complies with all of the requirements of 21 CFR 101.54(g). 
 
The nutrient content claim for your CurrantC™ Black Currant Nectar product of “…anti-oxidant rich berries…” does not include the names of the nutrients that are the subject of the claim as part of the claim, or use a symbol to link the term “antioxidant” to a symbol that appears elsewhere on the same panel of the product label followed by the names of the nutrients, as required by 21 CFR 101.54(g)(4). Therefore, the claim “…anti-oxidant rich berries…” does not meet the requirements of 21 CFR 101.54(g) and misbrands your product under section 403(r)(1)(A)(i) of the Act.
 
(b)(3)(A)
 
(b)(3)(A)
 
The violations cited in this letter are not intended to be an all-inclusive list of violations in your products, labels, and labeling. 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.
 
You should take prompt measures to correct all violations described in this letter and prevent their recurrence. Failure to take appropriate corrective action may result in legal action without further notice, such as injunction and/or seizure.
 
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing as to the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions.  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 you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining violations.
 
Your written response to this letter should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. 
 
If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 846-6207 or E-mail at dean.rugnetta@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District