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The Truvia Company, LLC.

Stevia World Interview Series

Feature dialogues with stevia experts including Mintel, Imperio Guarani, Burdock Group, GRAS Associates LLC, Overseas Natural Ingredients Ltd & WIXON, Cerrilant Corporation, Blue California, DSM Nutritional Products Ltd.

An overview of invited Speakers’ views on Stevia’s consumer perceptions, safety & flavor issues, as well as investment & social development potential in Stevia Cultivation etc.

Perspectives from Paraguay on Stevia Cultivation as a tool for Sustainable Development.

Stevia World Americas Speaker Sergio Chase, Director General of Imperio Guarani says the Stevia cultivation in Paraguay needs a stronger value chain and fair pricing for its long-term sustainability. Read more about our discussion with Sergio below.

The FDA’s sign of approval for Stevia rebaudioside-A is having a positive spin off effect in Paraguay. A new investment agreement between the US and Paraguay will encourage cultivation of stevia in Itapua region, located in the south of Paraguay. Under the agreement, non-profit NGO Paraguay Vende is to receive funding from the US Agency for International Development (USAID) to train farmers. The plant which is actually native to Paraguay will now provide livelihoods to one of the poorest regions in Latin America.

The first company to produce steviosides in Paraguay is Imperio Guarani, who started way ahead of the others in 2003. Since then, they have already established a growing program and extraction and purification facility to produce steviosides.

Using what their director general Sergio Chase describes as creation of “Stevia Belts”, Imperio Guarani identifies leaders who then ‘recruit’ their fellow farmers and manage them. His agricultural engineers work closely with the leaders and farmers to refine and improve growing practices. As a result, 40 hectares of Stevia in the “Estancia Pindó” – Curuguaty uses 100% irrigation, and is the first and only one in Paraguay.

According to Sergio Chase, “stevia is a sustainable industry” which “benefits local communities because it’s a very good alternative crop for farmers”. However, he also emphasised that the long-term success in stevia production will depend on strengthening the supply chain and buyers paying a good price for Stevia Leaves.

At Stevia World Americas, Sergio will be sharing his company’s experience with stevia cultivation and contract farming. You can confirm your seats for the conference happening on Feb 25-26 in Atlanta by submitting your registrations online.

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Dr. Richard Kraska sheds light on GRAS, FDA’s ‘Letter of No Objection’ and its implications for marketing Stevia in the USA.

Dr. Richard Kraska
In our second Stevia World Interview, Stevia World Americas Panellist Dr. Richard C. Kraska, the COO and Co-Founder of GRAS Associates LLC answers some key questions concerning the regulatory environment in the US. He also shared on the FDA’s GRAS notification process and explained what the FDA’s “No Objection” Letter means and how to obtain it.
Dr. Kraska has served in a supervisory position in the GRAS Review, and participated in safety evaluations for aspartame, cyclamate and even salt. Dr. Kraska’s session at Stevia World Americas conference will touch on the Health, Safety & Regulatory Advances” which are accelerating Mainstream Food Uses of Stevia-Derived Sweeteners.

Is FDA’s no-objection to GRAS the same as FDA approval? Please explain

By the very nature of GRAS exemption, the FDA “approval” process for GRAS ingredients has evolved into a rather informal process. The GRAS process as defined by the law is a consensus scientific process that does not even require FDA involvement.

No objection letters from FDA/CFSAN are a result FDA’s review of a GRAS notification. The background for the notification process is in a proposed regulation that FDA has not finalized to date.  However, FDA has implemented the notification system despite the lack of a final regulation.  FDA posts the no objection letters on their website in a GRAS Notice Inventory that was part of the proposed regulation.  If you use the phrase “FDA approval” in correspondence with CFSAN they will correct you and indicate that they do not approve products but they just define conditions for safe use of ingredients.

The notification process is less burdensome on the agency for several reasons, especially because the notifier must conduct a thorough review and describe and justify conditions of safe use by means of an expert panel rather than just supply reams of information for FDA to review in the old petition process.  I also think that FDA started the notification process to encourage industry to work with FDA, not use the “self-affirmation” process, and assure the public of FDA review for new food ingredients.

I can tell you that FDA’s review of GRAS notifications is also very thorough and the public posting of a no-objection letter which gives a great deal of detail about the review by the agency should be looked at as a reliable indication that the ingredient is safe for designated uses.

Do you foresee the FDA approving Stevia sweeteners as an ingredient in the future?

If the future of regulation of food ingredients remains in the hands of career FDA staff, I think the no-objection letter is as official as we are going to get from FDA on stevia and other ingredients that have gone through the GRAS notification process.

We know that the Obama administration is trying to increase the use of formal regulation at many agencies but there is no indication on what direction they want to go on food ingredients.  In the view of CFSAN, the GRAS notification process is working quite well and there is no reason to waste time with even finalizing the regulation.  CFSAN has a long history of not fixing what is not broken, so career staff at CFSAN will fight hard to retain the process.

There is also some pressure in Congress to completely overhaul the system and perhaps eliminate the GRAS exemption or even start a new GRAS review like it was done 30 years ago.  But we will have to wait and see on that one.

One important thing to remember is that no matter what level of approval exists for any ingredient, the FDA still has sufficient authority to get it off the market if new information arises about the safety.

What does it mean to ‘self-affirm’ your Stevia sweetener as GRAS?   What is the difference between self-affirmed GRAS and FDA’s no objection?

Self-affirmation means that the ingredient is found to be safe by an expert panel review but a notice is not submitted to FDA. Manufacturers try to market the product by sharing the expert panel report with potential customers.

In our experience, marketers of stevia have not been successful in importing products because the particular product is not on the GRAS Notice Inventory. This is one of the ways that FDA, with the help of other agencies such as US Customs and Border Protection, encourages the submission of GRAS notifications.  FDA also likes the control the notification system gives them because they can require each manufacturer or importer to submit a notification.

What are the important parameters that determine the safety and quality of stevia extracts?

In order to obtain a no-objection letter with a GRAS notification, the stevia product must be manufactured under Good Manufacturing Practices regulations and must meet the JECFA specifications for purity, which include the requirement that 95% of the dry weight of the product must consist of the seven glycosides recognized by JECFA.

What do you consider the key factors, which will increase the utilisation of stevia?

Based on everything I have read, the main factors for consumer acceptance in the marketplace are taste and cost. As time goes on and more products are available that are sweetened with stevia, we will see if the fact that the sweetener comes from a natural source gains traction with consumers.

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