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  5. Rock Farm, LLC dba WholeFood Farmacy - 552814 - 09/17/2018
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WARNING LETTER

Rock Farm, LLC dba WholeFood Farmacy MARCS-CMS 552814 —

Product:
Dietary Supplements
Labeling

Recipient:
Recipient Name
Linda L. Schoenrock
Rock Farm, LLC dba WholeFood Farmacy
Rock Farm, LLC dba WholeFood Farmacy

929 Winchester Highway

Fayetteville, TN 37334-2682
United States

Issuing Office:
Cincinnati District Office

United States


 

September 18, 2018
 
Warning Letter 552814


 

 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Linda L. Schoenrock, Owner and President
Rock Farm, LLC, dba WholeFood Farmacy
929 Winchester Highway
Fayetteville, Tennessee 37334-2682
 
Dear Ms. Schoenrock:
 
From March 6 - 12, 2018, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 929 Winchester Highway, Fayetteville, Tennessee. We reviewed copies of labels collected during the inspection for your Joule, Joule “Micro-Electric Current,” Stardust2Hydr8, and Hydrating Stardust products and your website at  www.wholefoodfarmacy.com, in July 2018. Based on our review, we have concluded that certain 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, we have determined that your Joule and Joule “Micro-Electric Current” products are adulterated within the meaning of section 402(c) of the Act [U.S.C. 342(c)] because they bear a non-permitted color additive.
 
Further, based on our review, we have concluded that your Joule, Joule “Micro-Electric Current,” Stardust2Hydr8, and Hydrating Stardust products are in violation of section 403 of the Act [21 U.S.C. 343] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101).
 
You can find the Act and subsequent regulations through links in our FDA’s Internet homepage  www.fda.gov.
 
Unapproved New Drugs and Misbranded Drugs
 
FDA reviewed your Farmacy Pro Power Superfood Probiotic Energy Blend, Joule, Joule “Micro- Electric Current,” Stardust2Hydr8, and Hydrating Stardust “A pH Infused Oral IV” product labels following the inspection of your facility. FDA also reviewed your website at the Internet address www.wholefoodfarmacy.com, in July 2018, and has determined that you take orders there for the products Farmacy Pro Power, Joule, Joule “Micro-Electric Current,” Stardust2Hydr8, Hydrating Stardust “A pH Infused Oral IV,” and DetoxiPhi. The claims on your labels and website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
Farmacy Pro Power Superfood Probiotic Energy Blend
 
Product label: “[ingredients in the product] Ginger, Tumeric [sic], and Aloe Vera reduce inflammation”
 
Website: “[ingredients in the product] Turmeric is getting a lot of attention from the medical world because of its benefits for pain and is also being researched for its anti-tumoral properties. . . Parsley and its volatile oils have been shown to inhibit tumor growth . . . milk thistle, proven to help with toxic conditions in the liver whether from environmental sources or ingestion of alcohol, smoke, or illicit drugs.”
 
Joule and Joule “Micro-Electric Current”
 
Product label: “[the product contains] medicinal gold” Website:
  • “Joule . . . has many healing properties including . . . reduced joint pains”
  • “It is documented that [an ingredient in the product] Gold can reduce joint pains and can provide an uplifting feeling against depression.” 
Stardust 2 Hydr8
 
Product label: “For thousands of years people avoided or cleared internal bacterial infections by drinking an oral infusion of salt water and leavening made of salt . . . Stardust 2 Hydr8 is perfectly balanced blend of Pure Salt and Bicarbonate of Soda.”
 
Website:
  • “Stardust 2 Hydrate . . . has numerous healing properties. Also beneficial in avoiding or clearing internal bacterial infections.”
  • “For thousands of years people avoided or cleared internal bacterial infections by drinking an oral infusion made from water, salt, leavening made from salt, and Stevia . . . Stardust 2 Hydr8 is handcrafted from Baking Soda, Stardust Pure Salt, and Stevia Leaf.” 
Hydrating Stardust “A pH Infused Oral IV”
 
Product label: “For thousands of years people avoided or cleared internal bacterial infections by drinking an oral infusion made from water, salt, leavening made from salt, and Stevia . . . Stardust 2Hydr8 is handcrafted from Baking Soda, Stardust Pure Salt, and Stevia Leaf.” 
 
DetoxiPhi
 
Website: “[an ingredient in the product] psyllium has been shown in some studies to reduce cholesterol including the LDL fraction”
 
Your Farmacy Pro Power Superfood Probiotic Energy Blend, Joule, Joule “Micro-Electric Current,” Stardust2Hydr8, Hydrating Stardust “A pH Infused Oral IV,” and DetoxiPhi 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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your Joule, Joule “Micro-Electric Current,” and DetoxiPhi products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
Adulterated Food
 
Your “Joule beverage- micro electric current” and “Joule beverage” products have flakes of gold that impart color to the products and therefore meets the definition of a color additive. Gold is not listed for use as a color additive in foods or any other FDA-regulated product. Even if your labeling did not contain claims that cause these products to be drugs, your “Joule beverage- micro electric current” and “Joule beverage” products appear to be adulterated under section 402(c) of the Federal Food, Drug, and Cosmetic Act because they appear to contain a color additive which is unsafe within the meaning of section 721(a) of the Act. Gold is a non-permitted color additive.
 
Misbranded Food
 
Even if your Joule, Joule “Micro-Electric Current,” Stardust2Hydr8, and Hydrating Stardust “A pH Infused Oral IV” products did not have therapeutic claims which make them drugs, they would still be misbranded foods under section 403 of the Act (21 U.S.C. § 343), in that the labels for these products do not comply with the labeling requirements in 21 CFR 101, as follows:
 
1.    Your Joule, Joule “Micro-Electric Current,” Hydrating Stardust, Hydrating Stardust “A pH Infused Oral IV,” and Stardust2Hydr8 products are misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the labels fail to declare the common or usual name of the foods consistent with 21 CFR 101.3(b). Specifically, Joule, Joule “Micro- Electric Current,” Hydrating Stardust, Hydrating Stardust “A pH Infused Oral IV,” and Stardust2Hydr8 are not appropriate common or usual names of foods. Further, terms such as “Micro-Electric Current” and “IV” are not terms which are appropriately descriptive for food products.
 
2.    Your Joule “Micro-Electric Current,” Hydrating Stardust, Hydrating Stardust “A pH Infused Oral IV,” and Stardust2Hydr8 products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product labels fail to declare the ingredients used as required by 21 CFR 101.4. Specifically:
 
a.  Your Joule “Micro-Electric Current” product label does not list the ingredients in descending order of predominance, because the weight of the xanthan gum in the product exceeds the weight of the cinnamon oil in the product, but they are listed on the label as cinnamon oil followed by xanthan gum. We also note that xanthan is misspelled as xanthum.
 
b.  Your Joule “Micro-Electric Current” product label lists raw aloe vera as an ingredient. However, aloe vera powder is used in the product.
 
c.  Your Hydrating Stardust, Hydrating Stardust “A pH Infused Oral IV,” and Stardust2Hydr8 product labels list “sweet leaf” as an ingredient, which is not the common or usual name for the stevioside sweetener used in the product, and Stardust Pure Salt, which is not the common or usual name for salt. Additionally, the Stardust 2 Hydr8 product label lists bicarbonate of soda, which is not the common or usual name for sodium bicarbonate or baking soda.
 
3.    Your Joule “Micro-Electric Current” 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 product labeling bears a nutrient content claim, but the product does not meet the requirements to make such a claim. Under section 403(r)(1)(A) of the Act, a claim which 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 on 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.
 
Specifically, your Joule “Micro-Electric Current” product label states the product’s aloe ingredient is “. . . high in naturally occurring . . . amino acids.” FDA has issued a regulation specifying criteria for the use of the nutrient content claims “rich,” “excellent,” and “high” in food labeling [21 CFR 101.54(b)(1)]. This regulation requires a food which bears these claims to contain 20 percent or more of the Daily Reference Value (DRV) of the nutrient per reference amount customarily consumed (RACC). However, this regulation does not authorize your claim because there are no DRVs for amino acids. The use of a nutrient content claim which uses the term “high” but does not comply with the requirements of 21 CFR 101.54(b)(1) misbrands a product under section 403(r)(1)(A) of the Act.
 
We note there are alternative ways to convey the amount of amino acids in your product to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). If you would like to seek authorization to use your current claim, you may submit a petition requesting FDA to authorize a new nutrient content claim for amino acids (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures the claim will provide consistent, meaningful information to consumers about the content of a product.
 
4.    Your product Joule “Micro-Electric Current” is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition information does not comply with the requirements in 21 CFR 101.9. The label contains statements regarding potassium, niacin, calcium, iron, magnesium, vitamin A, and riboflavin. Title 21 CFR 101.9(c)(8)(ii) states that the declaration of vitamins and minerals as a quantitative amount by weight and percent of the RDI shall include vitamin D, calcium, iron, and potassium, in that order, for infants through 12 months, children 1 through 3 years of age, pregnant women, lactating women, and adults and children 4 or more years of age. … The declaration of vitamins and minerals in a food, as a quantitative amount by weight and percent of the RDI, may include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section. The declaration of vitamins and minerals shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section as a statement of the amount per serving of the vitamins and minerals as described in this paragraph, calculated as a percent of the RDI and expressed as a percent of the Daily Value, when they are added as a nutrient supplement, or when a claim is made about them, unless otherwise stated as quantitative amount by weight and percent of the Daily Value.
 
Further, such statements for nutrients must be consistent with 21 CFR 101.13 and other applicable regulations under 21 CFR 101.
 
5.    Your Joule and Stardust2Hydr8 products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] because their labels fail to list the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Specifically, your Joule (red labels) and Stardust2Hydr8 label do not list the name and place of business of the manufacturer, packer, or distributor. Your Joule “Micro-Electric Current” lists an incorrect address for your firm.
 
This letter is not an intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. It is your responsibility to ensure that your firm and your products comply with the Act and all implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and injunction.
Additional Comments
 
We have the following comments regarding your firm’s operations:
 
During the inspection of your facility, you informed our investigator that your firm contracts with other manufacturers to manufacture and package dietary supplement products that your firm labels and releases for distribution under your firm’s name. You also informed our investigator that you were unaware of FDA’s regulation for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). To the extent you contract with other manufacturers to manufacture, package, and/or label dietary supplements which your firm releases for distribution under your firm’s name, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of such products comply with dietary supplement cGMP requirements in 21 CFR Part 111.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
 
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Please send your reply to Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
 
Sincerely,
/S/ 
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East