Most consumers know aloe vera as a succulent and source of soothing gel that has been used for thousands of years as a traditional remedy for sunburns and minor abrasions. Others know aloe vera as an ingredient in dietary supplements, beverages, cosmetics, and personal care products that have been around for decades.

The COVID-19 pandemic has led to a huge surge in demand for aloe in hand sanitizer in 2020 and sparked renewed interest in aloe vera to support immune health. Even more recently, aloe vera went viral on TikTok in early 2022 thanks to daily social media users sharing their experience of consuming aloe vera juice.

Yet despite the popularity of this widely available and recognizable ingredient, many consumers are unaware of the major regulatory developments of the past decade that have threatened the availability of aloe vera products around the world.

Europe

In 2021, the European Union (EU) finalized a proposal for a regulation that prohibits the use of “preparations made from the leaves of aloe species containing hydroxyanthracene derivatives” in foods and supplements. Hydroxyanthracene derivatives (HAD), in the form of aloin and aloe emodin, are natural compounds of aloe. The basis for this regulation was a 2018 scientific opinion from the European Food Safety Authority (EFSA) which raised health concerns about HADs in food. This regulation would have severely and, as aloe experts argue, unnecessarily restrict the aloe products available in the EU.

In response, the International Scientific Council of Aloe (IASC) – with Food Supplements Europe (ESF), Association of Official Analytical Chemists (AOAC), American Herbal Products Association (AHPA), and a number of other organizations representing consumers and the aloe industry in Europe – have strongly opposed the EU regulation. To challenge the proposed settlement, the IASC submitted comprehensive public comments on behalf of its international members, as well as several other leading associations and companies.

In these comments, the IASC identified the organization’s set limit for HADs in products containing aloe vera. The IASC quality standards for aloe vera set safe limits for consumption, content and contaminants. In addition, the IASC also clarified that EFSA’s scientific opinion cited data supporting the safety of low-HAD aloe vera preparations, but this information was not taken into account when making the assessment. risk assessment carried out by EFSA.

The effort led by the IASC and others resulted in the recognition of a threshold limit of

Taiwan

HAD concerns did not stop with the EU. Taiwan also recently announced new regulations for certain food products containing aloe vera. According to the Taiwanese Food and Drug Administration (Taiwanese FDA), plans are underway for new policies that would regulate the use of aloe in edibles by January 1, 2023.

As of January 1, 2023, only properly peeled aloe vera and aloe ferox leaves could be processed for use in edibles. Additionally, edibles cannot contain more than 10 ppm aloin and must include pregnancy warnings on their labels due to studies suggesting that long-term consumption of foods or supplements containing aloin may be toxic to the liver and kidneys.

In its regulations, the Taiwanese FDA referenced the IASC’s recommendation to set the maximum allowable content of aloin in edible products at 10 ppm. Developing this, the IASC submitted a scientific response to Taiwan regulations demonstrating the safety of aloin at low levels. Therefore, all products containing less than 1 ppm aloin will not need the additional warning labels in Taiwan.

United States

Much of the international regulatory attention given to aloe vera stems from studies by the U.S. National Toxicology Program (NTP) of a test material identified as “undecolorized whole leaf extract of Aloe barbadensis Miller”, an unpurified aloe vera material. The NTP concluded from their studies that this material, which contained high levels of aloin, was carcinogenic in rats after oral administration. The IASC consulted with the NTP to ensure that the study material was correctly identified as “not discolored” to differentiate it from aloe products available to consumers.

Following the publication of these NTP studies, the International Agency for Research on Cancer (IARC) published its cancer classification of “probably carcinogenic to humans” specific to this unpurified aloe vera test material. In April 2015, “Aloe vera, whole leaf extract” was proposed to be added to California Proposition 65 (Prop 65), based on the IARC classification of this material.

Prop 65 is a list of natural and synthetic chemicals known to cause cancer or birth defects or other reproductive harm. Companies are required to provide California consumers with warnings about significant exposure to chemicals listed in Prop 65.

Adding “Aloe vera, whole leaf extract” to the Prop 65 list could have significantly reduced the availability of aloe vera products in California due to the financial and operational impact for companies having to add labels warning to their products, points of sale, and marketing materials. Consumers also risked being unnecessarily scared away from safe aloe vera products due to labels warning of the risk of cancer and reproductive harm.

In response, the IASC and other organizations and individuals familiar with aloe vera submitted public comments differentiating between the test material in NTP studies and the aloe vera used in most consumer products. . Accordingly, the final Prop 65 listing announced in December 2015 added the important clarification that the aloe vera material listed in Prop 65 is “aloe vera, not discolored whole leaf extract. This crucial addition of the word “unbleached” has helped ensure that safe aloe vera products remain available in California.

Keeping Aloe Vera products safe and accessible

Thanks in part to its long history of use and its byword for soothing relief, aloe vera products have maintained a ubiquitous presence in the marketplace in both mainstream and specialty retail. However, keeping aloe vera products available to everyday consumers in the United States and abroad requires strategic, ongoing, and largely invisible regulatory efforts by the IASC and others. sector organizations. Additionally, not all aloe vera products are created equal.

The IASC is committed to supporting research on the aloe vera plant and promoting the safety and benefits of aloe vera in beverages, skin care, and many other types of consumer goods. At the heart of this long-established organization is the IASC certification program, which guarantees the content and purity of all certified aloe products. Consumers are encouraged to seek the IASC seal to ensure the quality and safety of their aloe products.

Related: The International Aloe Science Council…A Brief History