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World: Probiotic ingredient obtains regulatory approvals in 60 countries with hard work and patience, Ganeden Biotech tells FNI


Ganeden Biotech’s patented probiotic ingredient GanedenBC30 has obtained regulatory approvals in more than sixty countries throughout Africa, Asia, Europe, North and South America and Oceania; which has resulted in six international product launches in just the first quarter of 2014.

The ingredient (Bacillus coagulans GBI-30, 6086) can be found in more than 100 leading food, beverage and companion animal products throughout the world.

It is a spore-former that is stable and remains viable through most manufacturing processes.

It has three years of shelf life and the low pH of stomach acid.

The company says the efficacy of GanedenBC30 is backed by 17 published studies showing digestive and immune support and the ingredient has an exceptional safety record with US Food and Drug Administration (US FDA) generally recognized as safe or GRAS status.

By the end of 2014, the company expects to receive approvals in six countries; with many more to come in 2015.

Stephen Quinn, Ganeden’s international business development and regulatory manager shares with Food News International about the regulatory processes the company had undergone and its take on the future of the probiotics market.

FNI: What are the common requirements that Ganeden Biotech needs to take note of when applying for international regulatory approvals?

Quinn: Food and drug officials in every country are concerned with two main points: safety and efficacy.

They want to ensure that when a new product is being introduced to the market, it will not pose a public health risk and that it actually does what the manufacturer says it does.

For safety, we would usually provide toxicology studies, basic information about our process, manufacturing, quality control and our specifications.

To demonstrate efficacy, we provide peer-reviewed studies.

We would also always examine the regulatory environment of the other geographically close countries.

FNI: Is there a common process for the approvals?

Quinn: There really is no common process, as every country has its procedure that requires specialized attention.

In many countries, there is a formal application and a list of documents is needed.

We will often conduct discussions with the authorities over the phone to answer their questions.

In addition, having local distribution partners is extremely valuable in a more formal process because they operate in the local language and are able to have in-person follow up meetings as required.

FNI: Why is the overall regulatory process very thorough and can take anywhere from weeks to years?

Quinn: I do not think there are systemic or cultural reasons that approvals in some countries take longer than others.

I think it is just a matter of every government wanting to protect its people.

One factor, however, is the amount of credibility that a government gives to other government approvals and to existing research and development.

With Bacillus coagulans GBI-30, 6086having the US FDA GRAS status, it has been tremendously helpful in expediting some of our registrations in certain countries.

Likewise, our United States Pharmacopeia monograph gives us instant credibility with some food and drug authorities.

In other places, we have to start from the beginning and prove ourselves anew.

FNI: Could you share your experience in these regulatory approval processes?

Quinn: When obtaining regulatory approvals for our ingredient, hard work and patience pays off.

We have been working at obtaining regulatory approvals for years and will continue to do so into the future.

When an ingredient receives approval, it opens up opportunities for manufacturers to launch new functional food and beverage products.

FNI yogurt with berries

FNI: How does your company intend to capture the market with the international regulatory approvals?

Quinn:Bacillus coagulans GBI-30, 6086 is a well-documented and studied, patented probiotic strain – it is the opposite of a commodity.

With that mindset, it was a natural priority to expand our presence worldwide as we firmly believe that the global market is ready to expand beyond yogurt and supplements into innovative, consumer friendly food and beverage products.

FNI: What do you think of the growth of the international probiotic market?

Quinn: Consumer awareness on probiotics continues to grow.

Currently, about 80% of domestic consumers know what probiotics are and associate them with a health benefit.

They are decreasingly interested in taking another pill or forming new dietary habits, so they look for easy and convenient ways to support their healthy lifestyle.

Functional foods and beverages are a great way to receive the desired health benefits without varying their day-to-day routine.

In addition, at the research front, depending on the strain, we are seeing that probiotics support basic digestion, immune health, inflammatory responses and skin care.

Some research even suggests that probiotics support the metabolism, which can help fight obesity.

Where do you think the probiotic market is heading this year?

Quinn: The probiotic market will continue to grow and consumers are progressively more health conscious.

As they continue to look for convenient, lifestyle friendly probiotic applications, they will drive retail success for probiotic products.

We have seen just the beginning of innovative probiotic applications and we believe we can see more of them in the next several years.