Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm405018.htm
Timestamp: 2019-04-19 05:15:10+00:00

Document:
On September 4, 6, 12, 16, and 18, 2013, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Noni Connection, located at 905 Kalanianaole Hwy #10A, Kailua, Hawaii. During the inspection, our investigators collected labeling samples for your “Puna Noni 100% Pure Hawaiian Noni Juice” and “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” products. FDA has reviewed these samples, as well as the information on your website at www.nonialoha.com. Based on our reviews, we have concluded that your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” products are in violation of sections 505(a) and 502(f)(1) of the Act [21 U.S.C. §§ 355(a) and 352(f)(1)].
Even if these products did not have disease claims which make them unapproved new and misbranded drugs, their introduction into interstate commerce would nevertheless violate the Act. During the inspection, our investigators evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations, consistent with Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Our investigators found significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations, found in 21 CFR Part 111. These violations cause your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Additionally, your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” products are misbranded under sections 403(s)(2)(C) and 403(q)(5)(F) of the Act [21 U.S.C. §§ 343(s)(2)(C) and 343(q)(5)(F)], and your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” are misbranded under section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] and corresponding agency regulations.
We reviewed your product labels for “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” and your website, www.nonialoha.com, referenced on both product labels. Your product labeling and website promote these products 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 disease claims on your product labels and your website establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing these products into interstate commerce or delivering these products for introduction into interstate commerce for such uses violates the Act.
“Scopoletin: … chemical component of Noni juice… It is anti-inflammatory, anti-histamine, anti-fungal, and anti-bacterial. It regulates serotonin… helps ward off feelings of anxiety and depression… It is a vasodilator and lowers blood pressure. … As if these were not enough, scopoletin is also an analgesic.
The personal testimonials on your webpage entitled “Noni Testimonials” provide further evidence that “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” are intended for use as drugs. The testimonials recommend these products for the cure, mitigation, treatment or prevention of a variety of diseases, including arthritis, asthma, breast cancer, high blood pressure, kidney stones, lupus, ovarian cancer, and ulcerative colitis.
Your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” 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)(1) of the Act [21 U.S.C. §321(p)(1)]. 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 “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” 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 these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their 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)].
1. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you did not conduct any identity testing of the bulk noni power raw ingredient used to manufacture your Puna Noni 100% Pure Hawaiian Noni Capsules.
2. You failed to verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch) as required by 21 CFR 111.75(c). Specifically, you have not tested or examined any of the finished product lots for your Puna Noni 100% Noni Capsules to determine whether they meet product specifications.
3. Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container closure system in which the packaged and labeled dietary supplements were distributed, as required by 21 CFR 111.83(b)(1). Further, the reserve samples must be identified with the appropriate batch, lot, or control number and be held for at least one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplements associated with a reserve sample, as required by 21 CFR 111.83(b)(2)-(3).
1. Your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that it is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Specifically, the ingredient list does not declare the capsule ingredient as an “other ingredient,” in accordance with 21 CFR 101.4(g).
2. Your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni 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 label fails 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 101.4(h)(1).
3. Your “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” and “Puna Noni 100% Pure Hawaiian Noni Juice” products are misbranded within the meaning of Sections 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels fail to bear nutrition information in the form of a “Supplement Facts” label in accordance with 21 CFR 101.36.
The above is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that all of your products are in compliance with applicable statutes and regulations enforced by the FDA. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
In addition, our investigators noted that your firm assigns a shelf life of two years from the date of packaging to your Puna Noni 100% Pure Hawaiian Noni Juice capsules. Specifically, you code each bottle of this product with a two-year shelf life. Please note that the term “shelf life dating” includes shelf life dating as well as expiration dating and “best if used by” dating [see 72 Fed. Reg. 34752, 34912 (June 25, 2007)]. Any expiration date or equivalent term you place on a product label should be supported by data that demonstrates the product’s shelf life [see Fed. Reg. 34752, 34856 (June 25, 2007)].
Please respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. 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.
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 re-inspection 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.

References: § 342
 §343
 § 321
 §321
 §355
 § 352
 § 331
 § 343
 § 343