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CLOSEOUT LETTER

Healing Noni Co., LLC MARCS-CMS 492662 — Aug 26, 2016

Healing Noni Co., LLC - 492662 - 08/26/2016


Recipient:
Recipient Name
Michael D. Harvey
Healing Noni Co., LLC

13-1399 Kamaili Rd.

Pahoa, HI 96778
United States

Issuing Office:
San Francisco District Office

United States


  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700 

 

WARNING LETTER
 
August 26, 2016
 
Via UPS
Overnight Delivery
Return Receipt Requested
 
Michael D. Harvey, Owner
Healing Noni Co. L.L.C.
13-1399 Kamaili Rd.
Pahoa, HI 96778
FEI: 3011320745                                                                                          
 
Dear Mr. Harvey:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 13-1399 Kamaili Rd., Pahoa, HI 96778 from December 17, 2015 through December 22, 2015.  We also reviewed your firm’s website at the Internet address www.healingnoni.com in March 2016 and June 2016 and have determined that you take orders there for several of your products, including your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products. Based on our investigation and our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov
 
Unapproved New Drugs
 
Based on FDA’s review of your website at the Internet address www.healingnoni.com in March 2016 and June 2016, we have determined that you take orders there for the products including, but not limited to: HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice”.The claims on your website establish that these 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 labeling claims that provide evidence that your Noni Juice products are intended for use as drugs include:
  • “1-Hexanol – antiseptic”
    “Acetic acid – bactericide, fungicide”
    “Asperuloside – antiinflammatory, laxative”
    “Aucubin…bactericide…”
    “Benzoic acid – antiseptic, bactericide, fungicide”
    “Benzyl alcohol – anesthetic, antiseptic”
    “Caprylic acid – candidacide, fungicide…”
    “Eugenol – analgesic, anesthetic, antiinflammatory, antiseptic, cancer-preventive”
    “Limonene – anticancer, antitumor, hypercholesterolemic”
    “Linoleic acid – antiarteriosclerotic, cancer-preventive…”
    “Myristic acid – cancer-preventive”
    “Noni-ppt – antitumor…”
    “Oleic acid – cancer-preventive”
    “Palmitic acid – antifibrinolytic”
    “Scopoletin – analgesic, antiedemic, anti-inflammatory”
  • “Antiinflammatory activity – Anecdotal accounts of antiinflammatory effects resulting from noni fruit consumption are too numerous to dismiss. The antiinflammatory effects of asperuloside, eugenol and scopoletin present in ripe noni fruit would support such a claim. Other agents may possess additional antiinflammatory activity.”
  • “[A]ntitumor Activity - Hirazumi and Furusawa have described the activity of a polysaccharide-rich substance from the fruit juice of noni, noni-ppt. In studies, noni-ppt demonstrated …antitumor activity. The authors suggested that noni-ppt may be a valuable supplementary agent in cancertreatment. Okadaic acid in noni fruit has been determined by Asahina et al to increase the synthesis of tumor necrosis factor.”
  • PubMed# 19548275: “The findings suggest that preparations of noni fruits are effective in decreasing pain and joint destruction caused by arthritis.”
  • PubMed# 22344842 : “A few in vitro and in vivo animal studies suggest a possible unidentified substance in unpasteurized noni fruit juice that may have a small degree of anticancer activity.”
  • PubMed# 23534730: “Morinda citrifolia (Noni), a natural plant product, has been shown to have anti-cancer properties.”
  • PMC# 3434424: “Morinda citrifolia, also called Noni, is a tropical plant that grows widely throughout the Pacific. M. citrifola has traditionally been used for the prevention, and treatment of arthritis, circulatory weakness, diabetes, cancer, and skin inflammation [912]...”
  • PMC# 3477557: “Noni juice was able to mitigate cigarette smoke-induced dyslipidemia...”
  • PubMed# 18346148: “The immunomodulatory effect of noni puree may prove valuable in the future as production animal antibiotic use becomes more restricted.”
  • PMC# 3271418: “In vitro and in vivo research have shown that noni fruit juice possesses potential anti-obesity activity.”
  • PubMed# 16710899: “These results demonstrate that M. citrifolia contains a water-soluble component or components that interfere with the morphological conversion of C. albicans and the germination of A. nidulans and may have potential therapeutic value with regard to candidiasis and aspergillosis.”
  • PubMed# 19434757: “It was elucidated that the noni fruit juice inhibitory effect on XO enzymes is the mechanism by which noni ameliorates gout and gout-like diseases. Further, the results also support the traditional usage of noni in the treatment of gout.”
  • Pubmed# 20981320: “Morinda citrifolia is a medicinal plant used to treat diabetes and liver diseases.”
  • PMC# 2413119: “These results suggest that Noni juice is effective in protecting the liver from extrinsic toxin exposure.”
  • Pubmed# 17319624: “Morinda citrifolia L. is a traditional Polynesian medicinal plant which is apparently useful for bowel disorders, skin inflammation, infection, mouth ulcers and wound healing.” 
Your 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 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. 
 
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 noni juice products, HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” 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 HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” 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)].
 
Dietary Supplements CGMPs
 
Even if the labeling for your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products did not make therapeutic claims, which make the products unapproved new drugs, to the extent that you intend to market these products as dietary supplements, these noni juice products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). .
 
We acknowledge the receipt and have reviewed your Form FDA 483 written response letter submitted on January 8, 2016. We intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
During our inspection of your facility, our investigator observed the following significant violations:
 
1.    You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements. Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement, as required by 21 CFR 111.70(d). Specifically, during the inspection you stated that you did not establish specifications for your product labels and packaging and container closure systems that come into contact with your Healing Noni Brand: “Organic Noni Juice 100% Pure Noni Juice”.
 
Once you have established the above mentioned specifications, you must determine whether the specifications have been met in accordance with 21 CFR 111.73, 21 CFR 111.75(f) and 21 CFR 111.75(g), respectively.
 
We have reviewed your response dated January 8, 2016, and we intend to verify the adequacy of that corrective action at a future inspection.
 
Misbranded Dietary Supplements
 
Further, even if the labeling for your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products did not make therapeutic claims, which make the products unapproved new drugs, and to the extent that you intend to market these products as dietary supplements, these products would be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.   Specifically during the inspection of your facility, our investigator collected labels associated with many of your products. Our review of your product labels revealed that your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” are misbranded within as follows:   
 
1.    Your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice”products (16oz, 32 oz, 64 oz and 128 oz) are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. §343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. For example, 
    • Your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice”product labels fail to present nutrition information on the nutrition label using the title supplement facts in accordance with 21 CFR 101.36(e).
    • Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i). Your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” (16 oz, 32 oz, 64 oz and 128 oz) product labels list calories from fat, total fat, saturated fat, trans fat, cholesterol, dietary fiber, sugars, protein, vitamin A, calcium and iron with an amount of 0 and/or 0%DV.
2.    Your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice”products (16oz, 32 oz, 64 oz and 128 oz) are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because they do not comply with 21 CFR 101.3(d). Specifically, your statement of identity, “Liquid Dietary Supplement,” does not appear on the principal display panel. 
 
3.    Your HEALING Noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice”products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.36(d)(1) and 21 CFR 101.4(h)(1).
 
4.    Your HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products are misbranded under sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] and 403(r)(1)(A) [21 U.S.C. 343(r)(1)(A)] because your product labeling bears a nutrient content claim, but the products do not meet the requirements to make this claim.  
 
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.
 
Specifically, the labels of HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products bear the claim “great source of Antioxidants, Vitamins, enriched Minerals.”  Even if we determine that the term “great source” could be considered a synonym for a term defined by regulation (i.e., “high” or “good source”), the nutrient content claim must meet the requirements of 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. Your HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products declare a 0 percent content for all vitamins declared, except for 6 percent Vitamin C, as well as 0 percent for all minerals declared, which falls short of the 20 percent per RDI or DRV requirement.  Even if the term “great source” was a synonym for “high,” your goji juice products would not meet the requirements for a “high” nutrient content claim for the vitamins and minerals declared.
 
In addition, 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 (i.e., 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)).  It is not clear based on the information declared in your Nutrition Facts Panel or elsewhere on the goji juice product label what antioxidants you are referring to as the basis for this claim. 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.
 
Further, your HEALING Noni Brand: “all natural GOJI JUICE made with 100% PURE goji juice” products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the  nutrition information provided in the supplement facts label fails to declare the vitamins and minerals for which you have made a claim about in accordance with 21 CFR 101.36(b)(2)(i).
 
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations.  You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction. 
 
We also offer the following comments:
 
We note that you intend to market your products HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” as dietary supplements, but the product labels we collected during our inspection revealed that these products include representations for use as conventional foods. Specifically, the labels for your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” product labels contain the statement of identity on the principle display panel as “juice” and “100% pure goji juice” or “100% pure noni juice.”  This statement of identity implies that these products are used as beverages, as juice is a category of conventional food beverages. Your product labels also include a Nutrition Facts Panel rather than a Supplement Facts panel, as required for dietary supplement products. Finally, your website labeling includes a number of representations and testimonials that imply your noni juice products are for conventional food use, including statements such as:
 
-  “100% natural farm direct juice;”
-   “Noni recommends flavoring our pure Noni Juice with natural grape, cranberry apple or blueberry juice as needed to give it a delicious fruity taste;”
-  “Completely pure, with NO additives such as water, sugar, fruit juice, preservatives;” and
-  Testimonials suggesting: “drinking a couple of ounces of juice in the morning” and “I take about 4oz. of noni daily.”
 
Section 201(ff)(2)(B) of the Act provides that dietary supplements do not include products represented for use as conventional foods [21 U.S.C. § 321(ff)(2)(B)]. If your HEALING noni Brand: “ORGANIC NONI JUICE 100% Pure noni juice” and HEALING noni Brand: “all natural GOJI Juice made with 100% PURE goji juice” products are labeled as dietary supplements, they cannot also be represented for use as conventional foods because a product intended for use as a conventional food is not a dietary supplement. Such labeling would misbrand the products within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling would be false or misleading. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).
 
Our 2014 final guidance relating to the determination between liquid dietary supplement products and conventional food beverages can be found on our website: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm381189.htm
 
In addition we note that insofar you intend to market your products as dietary supplements, we also offer the following comment:
  • We have reviewed your Sample/Reserve Process Flow procedure and found it to be inadequate in that the retention specification established for your Bulk raw product does not meet the requirement as specified in 21 CFR 111.465(b). 
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary 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.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
Your written response should be sent to Lawton W. Lum, Director of Compliance at the address noted above and reference unique identifier 492662. If you have any questions concerning this letter, please contact Compliance Officer Lance De Souza at (510) 337-6873.
 
Sincerely,
/S/
Kathleen M. Lewis, J.D.
District Director
San Francisco District

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