From: Karen Masterson To: P65Public Comments Cc: Karen Masterson Subject: Aloe Life / NOILAloe Vera, Whole Leaf Extract Date: Friday, May 22, 2015 12:10:50 PM Attachments: 52115_1.pdf

Japanese Study.pdf

May 22, 2015

Dear Ms. Barajas-Ochoa,

Please open the 1st attachment letter to consider our companies opinion in the Prop 65 Terminology to include the words - Non Decolorized Aloe Vera Whole Leaf Extract.

It also shares with you the fact as a researcher there has never been a single death attributed to drinking any of the Aloe Vera products on the market; whole leaf, inner gel or even eating the plant itself.

IMPORTANT: State of CA. (for over 9 yrs.) already demands labeling on all Aloe Vera products to reduce the amount a person consumes if diarrhea.

See 2nd attachment - In case you have not seen the JAPANESE Study that models after the NTP/FDA Study on mice ingesting non-decolorized aloe vera stating that they did NOT conclude the Aloe Vera to be carcinogenic and felt it was due to the irritation of the intestinal tract.

FYI - What both studies do agree on is the fact that keeping the mouse body in a state of diarrhea is unhealthy. The issue is pivotal on the diarrhea and other studies show Aloe Vera to actually prevent colon cancer noted in this study from Japan. This is definitely a situation that has bloomed - not from people developing cancer from drinking Aloe Vera yet a desire to tarnish the use of the herb. People are different than mice in many ways and the conclusion that people are the same is just not accurate. 25 years of researching and working with Whole Leaf Aloe Vera has proven this fact without a doubt to me.

Respectfully,

mailto:karen@aloelife.commailto:P65Public.Comments@oehha.ca.govmailto:karen@aloelife.com

INTERNATIONAL

May 22, 2015

Ms. Esther Barajas-Ochoa Office of Environmental Health Hazard Assessment P.O. Box 4010, MS-19B Sacramento, California 95812-4010

Dear Ms. Barajas-Ochoa,

Regarding: Diarrhea with Aloe Vera's use internally. Attached is a significant scientific study to support the following comments. As a health researcher I have worked for great names in medicine who accomplished remarkable strides in immunology. This is how I became very interested in Aloe Vera and in case you are not aware of the fact NOT A SINGLE DEATH has ever been attributed to drinking Aloe Vera not a single one.

Thank you for reading this letter to support Proper Warning of Unprocessed Aloe Vera which brings upon diarrhea when left uncontrolled. I think reasonable adults understand that any mammal suffering daily diarrhea is in jeopardy of weakening the body be it mice or humans. The state of California mandated a law years back (9 years ago approx.) that all Aloe Vera products must put a warning on the instructions for the consumer to reduce the amount taken if diarrhea occurs. Aloe Life has adhered to this very strictly. Diarrhea can be dangerous!

Aloe Life is providing here comments to OEHHA's April 23, 2015 announcement of the intent to list "Aloe vera, whole leaf extract" as a chemical known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) due to its identification by the International Agency for Research on Cancer (IARC) as "possibly carcinogenic to humans" (Group 2B).

For 24 years Aloe Life has conducted significant trade in Aloe vera (aloe vera) primarily of the WHOLE LEAF ALOE VERA (WLAV) JUICE - properly processed for kids, adults and especially seniors. The Aloin which is identified to cause diarrhea is less than .1% from filtration.

The proposed listing DOES NOT PROPERLY PROTECT GOOD PRODUCTS THAT ARE TRULY SAFE and respectfully we request that OEHHA modify the title of the material to be listed so as to reduce any potential confusion that may occur between the proposed chemical and our Aloe materials.

Customer confusion has already begun years ago as the FDA launched a media blitz. People that thrive with their daily WLAV Juice have been calling on the company's 800 phone number wondering if there is any danger in the properly processed juices EVEN THOUGH THEY HAVE NEVER FELT BETTER AND HAVE NO BAD SIDE EFFECTS.

Our products are substantially different than the material identified by IARC that is the subject of the proposed listing. Our materials are derived from aloe vera whole leaf that has been purified by a process known as decolorization to remove known constituents of concern. The IARC aloe vera monograph clearly identifies four unique materials derived from Aloe vera, and how each material is different from the (nondecolorized) whole leaf extract that is the subject of the IARC classification.

In order to avoid confusion of what the proposed Proposition 65 listing covers and what it does not cover, Aloe Life respectfully requests that the title of the proposed material be modified to read "Aloe vera, NON -DECOLORIZED WHOLE LEAF EXTRACT" with an appropriate description to clarify that this material is an unpurified ingredient. We feel that this would provide a significant and important point of difference in order for us to properly inform our customers, and it is consistent with how the material of concern has been variously identified, including by the National Toxicology Program in the two-year carcinogenicity study that is the basis for the IARC classification.

In summary, Aloe Life requests that the aloe vera material that is the subject of Proposition 65 be identified with the underlined term inserted to read "Aloe vera, non-decolorized whole leaf extract."

Thank you for your consideration!

Sincerely, PzIL

Karen Masterson Koch President Aloe Life International Inc. Suite 169 11657 Riverside Drive, Lakeside, CA 92040 619-390-1100

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T:Toxicology&ChemicalFoodSafety

JFS T: Toxicology and Chemical Food Safety

Equivocal Colonic Carcinogenicityof Aloe arborescens Miller var. natalensisBerger at High-Dose Level in a WistarHannover Rat 2-y StudyM. YOKOHIRA, Y. MATSUDA, S. SUZUKI, K. HOSOKAWA, K. YAMAKAWA, N. HASHIMOTO, K. SAOO, K. NABAE, Y. DOI, T. KUNO,AND K. IMAIDA

ABSTRACT: A 2-y carcinogenicity study of Aloe, Aloe arborescens Miller var. natalensis Berger, a food additive, wasconducted for assessment of toxicity and carcinogenic potential in the diet at doses of 4% or 0.8% in groups of maleand female Wistar Hannover rats. Both sexes receiving 4% showed diarrhea, with loss of body weight gain. The sur-vival rate in the 4% female group was significantly increased compared with control females after 2 y. Hematologicaland biochemical examination showed increase of RBC, Hb, and Alb in the 4% males. The cause of these increasescould conceivably have been dehydration through diarrhea. AST and Na were significantly decreased in the malesreceiving 4%, and Cl was significantly decreased in both 4% and 0.8% males. A/G was significantly increased in the4% females, and Cl was significantly decreased (0.8%) in the female group. Histopathologically, both sexes receiving4% showed severe sinus dilatation of ileocecal lymph nodes, and yellowish pigmentation of ileocecal lymph nodesand renal tubules. Adenomas or adenocarcinomas in the cecum, colon, and rectum were observed in 4% males butnot in the 0.8% and control male groups. Similarly, in females, adenomas in the colon were also observed in the 4%but not 0.8% and control groups. In conclusion, Aloe, used as a food additive, exerted equivocal carcinogenic poten-tial at 4% high-dose level on colon in the 2-y carcinogenicity study in rats. Aloe is not carcinogenic at nontoxic-doselevels and that carcinogenic potential in at 4% high-dose level on colon is probably due to irritation of the intestinaltract by diarrhea.

Keywords: aloe arborescens Miller var. natalensis berger, Kidachi aloe, no observed adverse effect level, WistarHannover rats, 2-y carcinogenicity study

Introduction

Aloe arborescens Mill var. natalensis Berger (designated asAloe), a member of the family Liliaceae, is called KidachiAloe in Japan, where it is included in the list of existing food ad-ditives, developed by the Standards and Evaluation Div., Dept. ofFood Safety, Ministry of Health, Labour and Welfare. Aloe containsbarbaloin and aloenin as major components (Kuzuya and others2001) and has long been used as a medicine for treatment ofskin injuries and burns (Grindlay and Reynolds 1986; Koike andothers 1995). Various pharmacological and therapeutic activitieshave been studied, and have been reports of anti-inflammatory ef-fects (Fujita and others 1976), purgative action (Akao and others1996), antidiabetic influence (Beppu and others 2003; Beppu andothers 2006), and antitumorigenic effects of extracts (Shimpo andothers 2002, 2003). Recently, Shimpo and others reported mild sup-pressive effects of Aloe arborescens on azoxymethane-induced in-testinal carcinogenesis in the colon (Shimpo and others 2006) andinhibition of DNA adduct formation (Shimpo and others 2001). Acertain amount of Aloe consumption by humans is expected from

MS 20080655 Submitted 8/28/2008, Accepted 11/29/2008. Authors Yoko-hira, Matsuda, Suzuki, Hosokawa, Yamakawa, Hashimoto, Saoo, Kuno,and Imaida are with Onco-Pathology, Dept. of Pathology and Host-Defense, Faculty of Medicine, Kagawa Univ., 1750-1 Ikenobe, Miki-cho,Kita-gun, Kagawa 761-0793, Japan. Authors Nabae and Doi are withDIMS Inst. of Medical Science Inc., 64 Goura, Nishiazai, Azai-cho, Ichi-nomiya, Aichi 491-0113, Japan. Direct inquiries to author Imaida (E-mail:imaida@med.kagawa-u.ac.jp).

its pharmacological use by the oral route. Since administration maybe long term, toxicity and carcinogenicity assessment is required.

In a previous 90-d subchronic toxicity study of F344/DuCrj ratsadminis