A SPECIAL ALL-DIGITAL ISSUE VOLUME 3 ISSUE...

A SPECIAL ALL-DIGITAL ISSUE VOLUME 3 ISSUE 12 $20.75 US October 2013

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2 • Aloe Digital Issue • October 2013 | naturalproductsinsider.com

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All Eyes on Aloe

A SPECIAL ALL-DIGITAL ISSUE VOLUME 3 ISSUE 12 October 2013

3 Viewpoint

4 All Eyes on Aloe In the wake of the NTP’s recent study on aloe toxicity, industry has pointed out the research flaws, and reiterated the benefits and safety of aloe vera products.

13 Contact Us


VIEwpoInt

Aloe AllyI’m not the only one with childhood memories of aloe. For me, it

was a wooden pot in our front yard full of a green plant that looked scary—like cactus—but to my surprise, when I had a cut on my knee, my mom broke a stem open and applied the healing goo. I’m convinced that it was the healing process of that dangerous-looking plant that got me back on the bike after my fall. Well, that and an important kiss from my mom.

Twenty-five years later, aloe may still be deceiving consumers, but this time not for its looks. A recent study from the National Toxicology Program (NTP), a government organization that tests products for toxicity, found aloe can cause cancer in rats.

That’s pretty scary, but luckily, it doesn’t mean the aloe products that have become so popular are dangerous. See, the NTP study used a whole-leaf extract of aloe, but almost every product on the market processes its aloe to remove the toxic substance aloin.

The harsh side effects of the aloe constituent aloin, including diarrhea, help ensure that consumers wouldn’t continue to use such products even if they were available.

Unfortunately, NTP is not in the business of explaining nuances of their studies’ results versus what appears in the market; NTP just reported the results. And yes, if whole-leaf extracts of aloe were on the market, they could pose threats to consumers beyond many bathroom breaks.

But the numerous aloe-based drinks, creams, supplements and more likely don’t have high levels of substances that are linked to damaging effects, and brand owners can assure their consumers by getting third-party certifications and conducting the correct tests.

Safe aloe products offer plenty of benefits. Like the cuts from my youth, research has shown aloe helps speed wound healing, but the benefits go beyond that. From brain health to digestion and immunity, aloe is a great ingredient for maintaining health. And it isn’t scary.

Sandy Almendarez Editor in Chief, Natural Products INSIDER

(480) [email protected]@SandyAlmendarez


Viewpoint p. 3 ■ Contact Us p. 13 ■ Contents p. 2

all EyEs on aloe

INSIDER’s Take

¾ NTP’s study used whole-leaf extract that wasn’t purified, unlike many products on the market

¾ Brand owners can take measures to ensure their aloe products are safe and effective

¾ Aloe vera benefits brain, skin and digestive health

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For hundreds of years, consumers have used aloe products for variety of health benefits without a worry or care. With more than 400

species of aloe, the popular botanical does more than soothe a crisp sunburn—when used in beverages and a variety of other applications, aloe can aid digestion, help heal wounds and even act as an antibacterial gel. However, aloe’s most common species, aloe vera, has recently come under the spotlight due to safety concerns raised by a recent National Toxicology Program (NTP) study.

In the study, NTP, a program designed to investigate substances and their possible ill effects on health, found an aloe vera whole-leaf extract caused carcinogenic effects on the large intestines of rats.1 NTP collaborated with FDA’s National Center for Toxicology Research to conduct the two-year study, which showed the aloe extract caused tumors of the large intestines.

Industry organizations have responded to this study, clarifying that the research presented is misleading, and it leaves out key facts that are crucial for a full understanding of the issue.

For example, the research article left out the term “nondecolorized,” which means the aloe vera used in the study was not purified or filtered, and it contained 10,000 to 13,000 parts-per-million (ppm) aloin, a constituent found in aloe leaf’s yellow sap. According to a recent update from the International Aloe Science Council (IASC), that amount is 2,000-times higher than almost all commercially available aloe products.

“No one would consume any product that contains the amount of bitter aloin used in this study,” said Peter Hafermann, president, Improve USA, a division of Pharmachem Laboratories Inc. He said someone taking the extract used in NTP’s study would quickly fall ill, contract diarrhea and cease taking the product.

Hafermann added all IASC-certified decolorized aloe products contain safe amounts of aloin, indicating the study does not apply to most products consumers would buy on the market.

All Eyes on Aloeby Kate Kunkel


all EyEs on aloe


Santiago Rodriguez, CEO of Lorand Labs LLC, said brand owners should research the aloe products they provide to consumer and make sure don’t contain anthraquinones, especially aloin. He also said additional research is needed to “clarify the toxicity issue once and for all.

“NTP should repeat the study using an aloe with a level of aloin comparable to the commonly available aloe products on the market,” Rodriguez said.

Formulations, Standards and Best PracticesWhen formulating aloe products, manufacturers can minimize challenges by always

requiring IASC certification for their supply of raw ingredients, according to Hafermann. With this certification, they ensure a consistent ingredient that is most likely adulterant free and agrees with the American Herbal Pharmacopoeia (AHP) monograph.

If a formulator doesn’t vet its aloe materials, potential health risks could come into play, or the finished goods may not meet label claims, Hafermann added.

To properly manufacture aloe for nutritional use, a company may be challenged with rapid oxidation of active items within the aloe vera leaf, according to Tait Switzer, vice president of research and development/technical services, Mannatech. Simply cutting the leaf from the root at the wrong place can lead to a major loss in actives that could be harvested for later use. In addition, Switzer explained companies face another major challenge when filtering certain components within the plant while still retaining the parts they want to keep.

The best topical aloe formulations should contain at least 20-percent aloe vera in the final product, according to Jeff Barrie, eastern regional sales manager, Aloecorp. Ideally, the product would contain even more, but 20 percent offers substantial

NPT STuDy aT a GlaNcE

Study TitleClear Evidence of Carcinogenic Activity by a Whole-Leaf Extract of Aloe barbadensis Miller (Aloe vera) in F344/N Rats

What it tested Carcinogenic potential of aloe vera whole-leaf extract

ResultsAloe vera extract is an intestinal irritant in rats and mice; the extract has carcinogenic effects on the large intestine of rats.

Industry’s takeNTP’s study uses unpurified, unfiltered aloe containing a large amount of the powerful laxative aloin (about 2,000 times more than in commercially available aloe products).

ImplicationsAlmost all commercially available forms of aloe contain safe amounts of aloin; thus, these results would not apply when using an aloe product on the market.

Safety StudiesAlternate studies on decolorized aloe in gel, juice and topical formulations showed no carcinogenic effects in lab mice or rats.12, 13, 14, 15

Industry recommendations

Consumers should avoid consuming aloe products with high aloin contents—always check for the IASC seal to ensure safety standards have been met.



all EyEs on aloe

Learn more about aloe in INSIDERFor more information on aloe

products, safety standards and manufacturing practices,

visit the INSIDER features “aloe Veritas” and

“Mature aloe Vera Market Needs Fresh Standards.”

benefits for users, such as moisturizing effects on the skin. In addition, topical and oral treatments with aloe vera can benefit wound healing when formulated in this proportion, Barrie added. For drink applications, Aloecorp recommended two to three ounces of aloe per day.

To measure the quality of an aloe vera product, Rodriguez explained manufacturers should pay attention to the bioavailable and immunomodulatory acemannan content. The benefits of aloe only occur when properly manufactured, and without enough bioavailable acemannan, he said the product may disappoint both consumers and regulators.

“When finished product formulators do not use efficacious aloe in their formulations, consumers tend to think aloe vera claims are unrealistic,” Rodriquez said. “Secondly, many of the commercially available aloes do not contain enough biologically active acemannan to achieve any expected result.”

He added that industrial consumers should look at the acemannan content of raw materials in their aloe products to ensure the greatest efficacy possible.

Brain HealthConsumers use aloe for benefits ranging from digestive regulation and irritable

bowel syndrome (IBS) relief to immune system support. In addition, aloe is often used for cosmetic applications, antioxidant production, improved cognitive function and support of the body’s metabolism. Ken Jones, chief operating officer at Aloecorp, said extensive clinical studies display a wide variety of benefits from aloe supplementation.

“There are more than 2,000 published peer-reviewed scientific papers on the biological effects of aloe,” Jones said. “It’s no surprise that there are many people who use aloe vera on a daily basis.”

One recent study showed BiAloe®, an aloe polymannose multinutrient complex (APMC) manufactured by Lorand Labs, improved the cognitive and immune function of patients diagnosed with Alzheimer’s disease.2 Researchers tested participants’ cognitive function for a total of 12 months, and cognition scores proved function increased drastically by the end of the study. Stem cell production also increased in the aloe patients by 377 percent. The study’s researchers noted that long-term benefits require more investigation.



all EyEs on aloe

Another study on lab mice indicated a combination of Withania somnifera and aloe vera extracts offer preventative effects for reducing oxidative damage in the brain, while also lowering blood glucose levels and improving memory and motor skills in diabetic mice.3 The plant extracts were given to mice and evaluated on total antioxidant activity. Researchers also observed changes in the lab animals’ memory and motor functions, finding the significant impairments in diabetic mice were associated with damage from free radicals, but supplementing with the plant extracts helped reduce this oxidative damage.

Diabetes and Metabolic SyndromeWhile brain function associated with diabetes may improve with aloe extract

supplementation, further studies prove standardized aloe preparations can also revert the impaired fasting glucose and impaired glucose tolerance related to prediabetes/metabolic syndrome.4 Researchers tested 45 prediabetes patients with impaired fasting glucose or impaired glucose tolerance on various parameters of glycemia and oxidative stress. Aloe vera in inner leaf gel powder forms significantly reduced low-density lipoprotein (LDL) cholesterol, glucose, insulin, glycosylated hemoglobin (HbA1c) and fructosamine levels in the patients during an eight-week period.

Aloe also offers benefits for patients with type-2 diabetes and dyslipidemia by positively influencing blood glucose and lipid levels.5 A clinical trial involving hyperlypicdemic type-2 diabetic patients between the ages of 40 and 60 years showed taking one aloe gel capsule (300 mg) twice per day for two months can lower fasting blood glucose, HbA1c, total cholesterol and LDL levels. In addition, the supplement did not affect other blood lipid levels or liver/kidney functions, and no adverse effects were reported.

“There are more than 2,000 published peer-

reviewed scientific papers on the biological effects

of aloe. It’s no surprise that there are many people

who use aloe vera on a daily basis.”

— Ken Jones, chief operating officer at Aloecorp



all EyEs on aloe

DISCUSS The Scoop on Safety

Aloe vera’s applications, from constipation to wound care, have been a part of traditional medicine for centuries. However, based on recent studies indicating aloe may cause intestinal cancers, the Center for Science in the Public Interest (CSPI) issued a warning that consumers should avoid ingesting the plant’s extracts. Many companies within the aloe industry argue that the studies are misleading, and consumers should not confuse safe, tested products with the unfiltered versions often used by researchers.

In a response from Mannatech’s research and development (R&D) team, the company stated, “We were disappointed to see the CSPI recent warning that consumers should avoid all oral aloe vera products because they can increase the risk of intestinal cancers. CSPI’s warning reveals their lack of knowledge of aloe gel chemistry.”

The statement also explained some organizations, including CSPI, often make the mistake of referencing studies that investigate whole-leaf aloe products containing aloin, while the safety of purified, low-aloin aloe preparations has been confirmed through numerous studies.

Because aloin is a powerful laxative, it significantly affects colon health and causes dehydration, mineral and nutrient loss when used for an extended period, according to Devon Powell, executive director, International Aloe Science Center (IASC). He added any animal put into this state for its entire lifetime would likely develop health issues.

Recent information published by the International Agency for Research on Cancer (IARC) reiterated that unpurified whole-leaf aloe vera juice can produce carcinogenic effects, but the report stated purification removes the toxic latex constituents that raise concern.11 In an August 2013 update from IASC, Powell said the strong laxative effect of unpurified aloe would “make it obvious” to people consuming the product, and the process of decolorization ensures finished aloe products are free of toxic components found in aloe vera latex.

It is crucial to weigh in all factors of a research study to fully grasp an understanding of the



all EyEs on aloe

Skin HealthSupplementing with aloe does more than improve disease-related conditions—

another popular function includes a variety of cosmetic uses, especially involving skin health. Using aloe vera gel gloves provided benefits for 30 research subjects with bilateral occupational dry skin who wore the gloves while working on a factory assembly line.6 The gloves delivered aloe vera gel to participants’ hands, and each subject rated their skin dryness at baseline, during and at the end of the 30-day period. Researchers found the gelled gloves improved subjects’ skin integrity, decreased the appearance of fine wrinkling and decreased skin redness.

A later study proved cosmetic formulations containing freeze-dried aloe vera extracts improved skin hydration after a one- and two-week period of daily application.7 After two weeks of using an ACTIValoe formulation from Aloecorp, all 20 female subjects experienced dry skin relief without a significant effect on transepidermal water loss.

Aloe can also provide anti-aging benefits for those looking to reduce facial wrinkles and increase skin elasticity.8 A total of 30 females aged 45 years and older received two different doses (1,200 mg/day or 3,600 mg/day) of aloe vera gel supplementation for 90 days. By the end of the study, facial wrinkles improved significantly in both groups, while facial elasticity improved in the low-dose groups. Results showed aloe gel benefits skin health and appearance through its anti-aging properties.

results. In the case of NTP’s study on unpurified aloe vera, looking to other sources of research can help sort out facts from fiction, especially when a wide variety of studies point to the product’s proven safety.

New research on aloe beverages and ingredients offered to consumers continually reiterates aloe’s safety. Some of these studies proved the safety of a commercial stabilized aloe gel consumed in beverages,12 a whole-leaf aloe vera with the latex portion removed,13 and a purified whole-leaf aloe vera juice used in drinking water.14 These decolorized products showed no carcinogenic effects in lab mice or rats.

Researchers also used Qmatrix®, an aloe vera inner leaf fillet preparation from Aloecorp, to further prove the plant’s safety in oral and topical applications.15 During a 13-week study using lab rats, researchers administered Qmatrix in doses of 0, 500, 1000 and 2000 mg/kg body weight/day. Researchers found no treatment-related deaths or clinical signs of toxicity in any of the treatment groups.



all EyEs on aloe

Research indicates

drinking aloe vera in liquid

applications can increase

the bioavailability of

vitamins E, B12 and C in

the human body.||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

Vitamin AbsorptionOne newer application of aloe products includes consuming vitamins with aloe

rather than water. Research indicates drinking aloe vera in liquid applications can increase the bioavailability of vitamins E, B12 and C in the human body. One research study showed subjects who took a combination of either vitamin C or E with 2-oz. aloe preparations (a whole-leaf extract or an inner fillet gel) experienced improvements in both vitamins’ absorption rates.9 Aloe supplementation complements vitamin consumption because it slows absorption rates, allowing the vitamins to last longer within the body, according to the researchers.

Another recent study further proved aloe vera’s effect on vitamin C absorption, as well as its benefits involving the bioavailability of vitamin B12.10 Researchers found two different preparations of aloe vera—an aloe inner leaf gel and aloe whole-leaf decolorized gel—significantly increased plasma oxygen radical absorbance capacity (ORAC) of both vitamins at four and 24 hours after consumption. The preparations were well-tolerated by all 15 subjects and also enhanced the antioxidant potential of the vitamins.

Consistent QualityWith a wide range of uses and applications, aloe products on the market will

continue gaining popularity as they benefit consumers in coming years. The industry’s watchdog instincts will keep aloe customers informed of new studies and their validity, while strict safety standards offer assurance to all who use this popular botanical.

Manufacturers must closely monitor aloin content in their products to avoid the adverse health effects demonstrated in NTP’s study. Testing raw materials and finished goods, as well as using IASC resources to ensure safety compliance can help keep aloe products consistent and high quality for increasingly interested consumers. q



all EyEs on aloe

1. Boudreau MD et al. “Clear Evidence of Carcinogenic activity by a whole-leaf Extract of aloe barbadensis Miller (aloe vera) in F344/n Rats.” Toxicol Sci. 2013; 131(1):26-39.

2. lewis JE et al. “the effect of an aloe polymannose multinutrient complex on cognitive and immune functioning in alzheimer’s disease.” J Alzheimers Dis. 2013;33(2):393-406.

3. parihar Ms et al. “susceptibility of hippocampus and cerebral cortex to oxidative damage in streptozotocin treated mice: prevention by extracts of withania somnifera and aloe vera.” J Clin Neurosci. 2004 May;11(4):397-402.

4. Devaraj s et al. “Effects of aloe vera supplementation in subjects with prediabetes/metabolic syndrome.” Metab Syndr Relat Disord. 2013 Feb;11(1):35-40.

5. Huseini HF et al. “anti-hyperglycemic and anti-hypercholesterolemic effects of aloe vera leaf gel in hyperlipidemic type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial.” Planta Med. 2012 Mar;78(4):311-6.

6. west Dp, Zhu yF. “Evaluation of aloe vera gel gloves in the treatment of dry skin associated with occupational exposure.” Am J Infect Control. 2003 Feb;31(1):40-2.

7. Dal’Belo sE et al. “Moisturizing effect of cosmetic formulations containing aloe vera extract in different concentrations assessed by skin bioengineering techniques.” Skin Res Technol. 2006 nov;12(4):241-6.

8. Cho s et al. “Dietary aloe Vera supplementation Improves Facial wrinkles and Elasticity and It Increases the type I procollagen Gene Expression in Human skin in vivo.” Ann Dermatol. 2009 Feb;21(1):6-11.

9. Vinson Ja et al. “Effect of aloe vera preparations on the human bioavailability of vitamins C and E.” Phytomedicine. 2005 nov;12(10):760-5.

10. yun JM et al. “a randomized placebo-controlled crossover trial of aloe vera on bioavailability of vitamins C and B(12), blood glucose, and lipid profile in healthy human subjects.” J Diet Suppl. 2010 Jun;7(2):145-53.

11. Grosse y et al. “Carcinogenicity of some drugs and herbal products.” The Lancet Oncology. 2013; 14(9):807-808.

12. sehgal I et al. “an in vitro and in vivo toxicologic evaluation of a stabilized aloe vera gel supplement drink in mice.” Food Chem Toxicol. 2013 May;55:363-70.

13. sehgal I et al. “toxicologic assessment of a Commercial Decolorized whole leaf aloe Vera Juice, lily of the Desert Filtered whole leaf Juice with aloesorb.” Journal of Toxicology. 2013.

14. shao a et al. “safety of purified decolorized (low anthraquinone) whole leaf aloe vera (l) Burm. f. juice in a 3-month drinking water toxicity study in F344 rats.” Food Chem Toxicol. 2013 Jul;57:21-31.

15. williams lD et al. “safety studies conducted on a proprietary high-purity aloe vera inner leaf fillet preparation, Qmatrix.” Regul Toxicol Pharmacol. 2010 Jun;57(1):90-8.

References


Natural Products INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry. INSIDER boasts the largest magazine and web audience in the industry delivering news, analysis and features to executives involved in the expanding market of global nutrition. The Natural Products INSIDER brand includes a print magazine, a website, e-newsletters, reports, webinars, whitepapers, digital issues and image galleries.

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