April 22, 2014
Terry D. Durham, Owner
River Hills Harvest dba Elderberrylife
19010 S Mackie Ln.
Hartsburg, MO 65039-9112
Dear Mr. Durham:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 19010 S. Mackie Ln, Hartsburg, MO 65039, from November 18, 2013 to January 24, 2014. During the inspection of your facility, our investigator collected labels and labeling for your products. FDA has determined that the labeling for your "100% Pure Premium Elderberry Juice" promotes the product 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 labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained below, introducing or delivering for introduction this product into interstate commerce for such uses violates the Act.
Further, our review of your product labeling also revealed that your "
100% Pure Premium ElderBerry Juice" product is misbranded within the meaning of section 403 [21 U.S.C.
§ 343] of
the Act, and the implementing regulations contained within Title 21, Code of Federal Regulations, Part
101 (21 CFR 101). You may find the Act and FDA's implementing regulations through links on
FDA's home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the labeling claims that provide evidence that your product is intended for use as a drug include:
Elderberry Juice Products Brochure
- "[E]Iderberry juice and extracts possess antiviral, immune modulation and anti-inflammatory properties used to treat the common cold, flu, Herpes, diabetes and even some forms of cancer."
- "The fruit...isused to relieve...high cholesterol...and to fight the flu-all strains."
- "The results of a clinical trial...showed flu patients given one tablespoon of elderberry extract four times per day recovered in an average of 3.1 days compared to 7.1 days for those given a placebo."
- "Elderberry will boost the immune system and works well for colds...elderberry juice is probably one of the biggest cold secrets around. Works very well to get rid of that cold and flu"'
- [U]sed as joint anti-inflammatory..."
- "Commonly used against cold, flu, sore throats, coughs, bacterial and viral infections, allergy [sic] relief and urinary tract I bladder infections."
- "Commonly used to... lower cholesterol... and to alleveiate [sic] joint and muscle pain."
"100% Pure Premium ElderBerry Juice" Label (11 fl. oz. Bottles)
- "Native ElderBerry varieties possess ...antiviral...properties."
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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 "100% Pure Premium ElderBerry Juice" 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 purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
Even if your "100% Pure Premium ElderBerry Juice" product did not include claims that cause it to be a drug, it is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] as follows:
1. Your "100% Pure Premium ElderBerry Juice" 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 labeling for the product 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 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 misbrands the product under section 403(r)(1)(A) of the Act. Additionally, characterizing the level of a nutrient in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
The labeling (product brochure) for your "100% Pure Premium ElderBerry Juice" product bears the claim "a great source of antioxidant flavonoids quercentin and rutin as well as seven different anthocyanins the same four present in the European S. nigra plus three more." In the context of this labeling, the phrase "great source" is an unauthorized synonym for a "high" nutrient content claim. FDA has defined the nutrient content claim "high" and its authorized synonyms in 21 CFR 101.54(b). "High" nutrient content claims may be used on the label or in the labeling of foods, provided that the food contains 20 percent or more of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) per reference amount customarily consumed. There is no established RDI or DRV for quercetin, rutin or any anthocyanins. Therefore, even if the term "great source" was an authorized synonym for "high," your "100% Pure Premium ElderBerry Juice" product would not meet the requirements for a "high" nutrient content claim.
Nutrient content claims using the term "antioxidant" must also 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, an 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)). 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.
The nutrient content claim for your "100% Pure Premium ElderBerry Juice" product of "a great source of antioxidant flavonoids quercetin and rutin as well as seven different anthocyanins the same four present in the European S. nigra plus three more" does not meet the requirements to make such a claim because there are no established RDIs for quercetin, rutin or any anthocyanins. Therefore, the claim "a great source of antioxidant flavonoids quercetin and rutin as well as seven different anthocyanins the same four present in the European S. nigra plus three more" does not meet the requirements of 21 CFR 101.54(g) and misbrands your product under section 403(r)(1)(A) of the Act.
Additionally, the brochure for your "100% Pure Premium ElderBerry Juice" product contains the nutrient content claim "[M]ore vitamin C than oranges..." "More" nutrient content claims may be used on the label or in the labeling of foods to describe the level of nutrients, provided that (1) the food contains at least 10 percent more of the RDI or DRV for the nutrient per reference amount customarily consumed than an appropriate reference food; (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20; and (3) the claim bears the required information for relative claims as described in 21 CFR 101.130)(2) and 101.54(e)(1)(iii). The labeling for your "100% Pure Premium ElderBerry Juice" product does not include the percentage (or fraction) that the nutrient is greater relative to the RDI or DRV (21 CFR 101.54(e)(1)(iii)(A)), and it does not contain quantitative information required by 21 CFR 101.54(e)(1)(iii)(B).
2. Your 100% Pure Premium ElderBerry juice is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product purports to be a beverage that contains juice but fails to bear the percent juice statement on the information panel. Specifically your product bears a 100% juice declaration on the principal display panel but the100% is not accompanied by a qualifying phrase that identifies the non-juice ingredients in accordance with the requirements of 21 CFR 101.30(b)(3).
Under 21 CFR 101.30(b)(3), if the beverage contains 100 percent juice and also contains non-juice ingredients that do not result in a diminution of the juice soluble solids or, in the case of expressed juice, in a change in the volume, when the 100 percent juice declaration appears on a panel of the label that does not also bear the ingredient statement, it must be accompanied by the phrase "with added_, "the blank filled in with a term such as "ingredients(s)," "preservative," or sweetener" as appropriate..."
3. Your Pure Premium 100% ElderBerry Juice is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition facts information is not declared in accordance with 21 CFR 101.9. Specifically, a serving size of "1 Tablespoon" is not in accordance with the reference amount customarily consumed that is required for juice products as under 21 CFR 101.12.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office in writing within (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S
. Food and Drug Admin
. Ann M. Adams
ing District Director at the address noted above. If you have any questions with regard to this letter
, Compliance Officer Matthew R. Sleeter can be reached at (913) 495-5151 or email Matthew.Sieeter@fda.hhs.gov
Ann M. Adams
Kansas City District