Noni Connection dba Puna Noni 7/14/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700
July 14, 2014
UNITED PARCEL SERVICE
Reference: CMS 414582
Nimai M. Titcomb, President and Co-Owner
Kainoa R. Penroza, Co-owner
Noni Connection dba Puna Noni
905 Kalanianoale Hwy #10A
Kailua, HI 96734
Dear Mr. Titcomb and Mr. Penroza:
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.
You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drug Violations
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.
Examples of some of the claims that provide evidence that your products are intended for uses as drugs include:
(1) Website homepage (www.nonialoha.com)
- The first paragraph of your website homepage states, “Noni (morinda citrifolia) is one of the world’s most important healing plants…Recently, the healing and cancer fighting properties of Noni have been confirmed by modern scientists.”
- Under the heading, “Noni Selected Reading,” your homepage states: “Noni Shows Cancer Promise” and “Cancer Research Center of Hawaii researchers are getting reports from patients taking noni that they have less pain that interferes with activities.”
- Under the heading, “Featured Testimonial,” you homepage states: "Your Noni Juice has changed my daughter's life. At 7, she started having…constipation…My daughter has been drinking your Puna Noni juice for almost one year, and she has not missed a single day of school…Her immune system is much stronger and she no longer catches every illness that is going around. To this day, her doctors have never diagnosed her condition…”
(2) “Noni Health Benefits” webpage (www.nonialoha.com/HEAL.html)
- “Noni is still used by the local population in Hawaii for diabetes, high blood pressure…abnormal growths, and other chronic disorders…”
- “[P]olysaccharide-rich substances found in Noni fruit juice attack abnormal cells and abnormal growths by stimulating body’s immune system…In animal cancer studies, Noni juice treatments reduced the formation of abnormal cells in the heart, lungs, liver…”
- “Phytonutrients: Natural chemicals found in Noni juice…ward off disease…also believed to block processes that lead to cancer”
- “Selenium: … trace element found in Noni juice … may prevent blood clotting and hypertension.”
- “Anthraquinones (Damnacanthol): Important antiseptic and anti-bacterial plant chemicals found in Noni juice.”
- “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.
- “Alkalinity: Tissues degrade and disease thrives in an acidic environment. Noni juice promotes an alkaline body chemistry, the optimal state for good health.”
- “Anti-oxidant: Anti-oxidants, such as green tea, pynogenol, and vitamin C, among others, are important in neutralizing “free radicals,” or particles that cause DNA damage that can lead to cancer. Noni juice has recently been found to be the most effective of all known anti-oxidants.”
- “Analgesic, Anti-Inflammatory, and Selective Cox II Inhibitor: … Noni Juice decreases pain and inflammation while protecting stomach, kidney, and liver cells.”
(3) “Noni Testimonials” webpage (http://www.nonialoha.com/TSTL.html)
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.
- The testimonial under “Arthritis” states: “My mother has been on noni 6 weeks and the results are very visible. Where she was suffering from arthritis and other ailments, she is walking with no pain and enjoying life again. Noni is doing what other expensive medications were not able to do, not to mention all the side affects [sic], which nearly put her in a coma, and in the hospital for 11 days.”
- The testimonial under “High Blood Pressure” states: “I have been using your Noni juice for about 3 weeks now, I am using it for my blood pressure and it works almost instantly my blood pressure has returned to normal again.”
- One of the testimonials under “Ovarian Cancer” states: “I have recurrent ovarian cancer and I believe Noni (and God working in my life) is keeping it stable. I was on my 2nd round of chemo in Feb and Mar 2005 when it was determined that it wasn't working. I traveled to Hawaii and was led, quite by happenstance, to Noni, and I haven't been back on chemo since! My blood tests (CA125) are around the same as they were back in January when I was diagnosed with recurrent disease. This is truly amazing, since recurrent ovarian cancer NEVER just stabilizes on its own without chemotherapy. It is not in remission, but does not appear to be spreading. I feel better than I have in years. I could live to be an old lady (I'm 53) with stable disease, but not if it spreads. Recurrent ovarian cancer is not curable, only treatable. I believe Noni is keeping me healthy and giving me a reprieve from chemo.”
(4) “Noni Cancer Research” webpage (www.nonialoha.com/CANC.html)
Moreover, a personal testimonial on the “Noni Cancer Research” webpage provides 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. This testimonial recommends these products for the cure, mitigation, treatment or prevention of cancer:
- Under the section entitled “Metastatic Prostate Cancer,” you provide the following physician testimonial: "A 75 y/o male with metastatic prostate cancer, most recent PSA of 55, I added ... Noni to his conventional treatment regimen and within 2 weeks, his PSA was 1.1."… There is simply nothing else I am aware of that could possibly reduce Prostatic Specific Antigen from 55 (indicating uncontrolled cancer) to a normal 1.1, and DO IT IN JUST 2 WEEKS.”
When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of how you have used scientific publications to market your products for disease treatment and prevention on your website and are thus evidence of your products’ intended use as a drug:
- Under the section entitled “Anti Cancer Activity,” you refer to and summarize a study by Hirazumi et al. Your summary states: “The research team concluded that Noni juice acts as an anti-cancer agent by indirectly enhancing the cancer host's immune system of macrophages and/or lymphocytes.”
- Another section summarizes a study entitled “Induction of Normal Phenotypes in RAS transformed cells by Damnacanthal from Morinda Citrifolia.” Your summary states: “In this study, a team of Japanese researchers studied the effect of more than 500 extracts of tropical plants on K-ras NRK cells (a precursor to certain types of cancer). One particular compound, damnacanthal, found in Morinda Citrifolia (the scientific name for Noni), was shown to be an inhibitor of Ras function…This same compound has been found to inhibit the Epstein Barr virus early-antigen activation. The extract from the Morinda Citrifolia was found to be most effective in inhibiting Ras function among the 500 tested extracts[.]”
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)].
Dietary Supplement CGMP Violations
Even if the “Puna Noni 100% Pure Hawaiian Noni Fruit Capsules” product discussed above were not an unapproved new and misbranded drug, its introduction into interstate commerce would nevertheless violate the Act. In the absence of the disease claims discussed above, the product would be a dietary supplement that is adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements under 21 CFR Part 111. Specifically, during the inspection of your facility, our investigators observed the following:
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).
Dietary Supplement Misbranding Violations
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.
Please send your reply to the attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Brandon Bridgman, Compliance Officer at 510-337-6794, or by fax at (510) 337-6703.
Kathleen M. Lewis, J.D.
San Francisco District Office