FDA warning letter reminds industry whole stevia leaf is not GRAS or an approved food additive

By Elizabeth Crawford contact

- Last updated on GMT

FDA tells industry whole stevia leaf isn't GRAS approved food additive

Related tags: Stevia

A recent FDA warning letter reminds food and beverage manufacturers that whole stevia leaf is not generally recognized as safe for conventional foods, even though many extracts of the plant are.

Nor is there any food additive regulations that authorize the use of whole-leaf stevia or its crude extract in food, the agency tells Ten Ren Tea Company of San Francisco in a July 31 warning letter​. 

Therefore, it adds, “stevia leaf is not allowed for use in any food, including teas,”​ which means the company’s three teas with the ingredient are “adulterated.”

The reminder that only certain stevia-based products are allowed in conventional food comes at a time when many manufacturers have become more comfortable with using stevia in foods and beverages since FDA first accepted with no objection a GRAS notification​ for a highly purified extract of the plant in 2008, said Ivan Wasserman, a partner at the law firm Manatt, Phelps & Phillips who specializes in food and drug law.

The letter also echoes warnings FDA delivered to at least two other firms in the past three years. The need for repeated warnings could signal industry-wide confusion about when and what parts of stevia are allowed in food and supplements.

In 2012, the agency told CocoKefier​, which used stevia as a sweetener is three flavors of its Tula’s CocoKefier drinks that “whole-leaf and crude stevia extracts are not approved for food use as a sweetener.”​ However, FDA added, “certain highly purified steviol glycoside obtained from stevia leaves have been the subject of generally recognized as safe (GRAS) notices,” ​and the agency “has not objected to the use as sweeteners of these highly refined substances, which are generally referred to as Rebaudioside A.”​ 

The agency in December 2013 said the same thing​ to Mayor Laboratories, Inc., which listed stevia under “other ingredients”​ in several supplements, including its Pre-Natal spray, Melatonin spray, Children’s Multiple spray, C+Zinc spray and other Vitamist sprays. 

Stevia leaf technically meets the definition of a dietary ingredient as a botanical and can be used as a dietary ingredient as long as the intention for including it is not for flavor and no sweetening claims are made, said Dan Fabricant, CEO of the Natural Products Association.

If, however, a supplement maker wants to include stevia as a sweetener, it would need to list it as a food additive in the “other ingredients”​ portion of the Supplement Fact box and ensure that it uses a JECFA monograph approved version of stevia, he added.

As for using stevia in food, manufactures must ensure that the extract they use is subject to a GRAS notification that the agency has accepted without objections. To date, FDA has filed 35 GRAS notifications for stevia extracts​. 

Despite companies’ efforts, none of the notifications accepted by FDA are for whole-leaf Stevia or crude extracts, the agency said in the warning letter to Ten Ren Tea Company.

It explained that previous inquiries and petitions related to whole-leaf Stevia or its crude extracts in food “have been lacking” ​data and information necessary to support the safe use.

Specifically, FDA explains on its website​ that it does not consider these ingredients GRAS “in light of reports in the literature that raise concerns about the use of these substances,”​ including concerns related to the control of blood sugar and effects on the reproductive, cardiovascular and renal systems. 

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3 comments

stevia glycosides = truvia = coca cola company = profits

Posted by Your saviour,

The FDA is in bed with big corporations such as Coca Cola and is supporting a marketing campaign to replace (natural) Stevia
with (chemically-modified) Stevia extracts aka Truvia/Stevia glycosides. All I will say is do your research. If you think the FDA prioritizes your health over profits, think again. Stevia has gained traction in recent years since more and more people are becoming aware of the potential dangers of synthetic sweeteners (made by coca cola and its subsidiaries). Initially, FDA disapproved of Stevia as a mainstream sweetener as it was a threat to the synthetic sweetener industry i.e. profits. They have not thoroughly investigated the safety of Stevia. But Stevia has been consumed for thousands of years by developing countries without any adverse effects. It's funny now that the synthetic sweetener industry is taking a hit that the FDA would now approve Stevia extracts. What makes the Stevia leaf so unsafe, yet they are willing to market its extracts? Oh and the reason why they are not employing the use of whole Stevia is the cheaper methods by which the extracts can be made. That and they would look like hypocrites suddenly approving a product they were outright claiming was unsafe. Summary: Don;t touch Stevia extracts/Truvia, don't trust FDA, and keep consuming Stevia as normal.

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Relax with a Coke

Posted by David Faires,

Steviol glycoside has an EU additive number and we're not dead yet! The extract is in one of the range of a little known soft drink manufacturer the Coke-Cola Corporation! Must be OK.

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Confusing Stevia Terms

Posted by Andrea Cid,

Hi Elizabeth,
Good article outlining the FDA's somewhat confusing stance on stevia and stevia extract. You should point out that while a stevia leaf is not GRAS, it's extract, when 95% or more steviol glycoside *is* GRAS. You do mention Reb A, which is a more targeted extract of just one molecule. These distinctions, while somewhat FDA arbitrary, are however important, because there is much confusion about what is and isn't GRAS. Of course, the real question is why a leaf used for hundreds of years, much like tea, is not approved for use in foods by the FDA.

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