Difference between revisions of "Team:Mingdao/HP/Silver"

Introduction 

The Food Industry Research and Development Institute (FIRDI)is a non-profit research institution in Taiwan. Established in 1965, the main work includes product development, biological resources preservation (gene bank for instance), biological inspection (such as paternity tests).In addition, it also has a section to store umbilical cord blood.

Motivation 

During our last time’s meet-up with NCTU, we told them our plan to consult FDA about Lactobacillus manufacturing. Professor Chen, the leading professor of NCTU IGEM team, said that FDA is an institute offering expertise related to regulations and examination processes. He suggested that we may get what we need from FIRDI (Food Industry Research and Development Institute). After doing some researches and preparations, we successfully reached Dr. Chu in FIRDI. 

Highlight :

The above are some advice he gave us:

1. You would do well to use E. coli without a plasmid.
2. Make sure whether E. coli is able to survive in the intestine.
3. Remain balanced nutrients when growing lactobacillus instead of just adding sugar. 

Conclusion 

After Doctor Zhu’s detailed introduction, we found that it seems too late for us to know what FIRDI is. We solved the difficulties we faced in our experiment in the end, but if we had discussed with Doctor Zhu earlier, the progress of our experiment might have been faster and more efficient. Thanks to this interview, we realized our insufficient, knowing we still have a lot to improve as well. Here, we appreciate all the instructions Doctor Zhu gave us and professor Chen for recommending us visit FIRDI.    

Records 

We: We want to know the current situation of the obesity problem in Taiwan.

FDA: I suppose the question could be more probably answered by the Health Promotion Administration. The point is that the public shall be more aware of the negative effects of consuming too much sugar. Therefore, we have started to take notice of the amount of refined sugar consist in health supplements six years ago. In order to avoid people who aim to have a healthy life from consuming too much sugar, we have required more than 30 manufacturers to reduce the amount of sugar added to their products. 

We: So, what’s the point of regulating calorie from refined to 10% of daily sugar intake?

FDA: The institution is based on the reference from WHO. For we normally eat many other kinds of food every day, we regulate that refined sugar added in items that can be called “heath food” should not exceed 50 grams, which is half of daily sugar intake for adults. Also, if a product contains over 1/3 of the limited amount mentioned, it should be labeled. 

We: What examination do we need to go through if we are to commercialize our product? 

FDA: If it is positioned to a kind of common food, it won’t be required to pass any examination procedures. But, if you are to make it a health food warranted by the government, it is necessary that you pass the inspections on food additions and ingredients. The list of ingredients that could be added is now available on the internet. Manufactures are required to hand in their examine result themselves. 

We: If we are now planning to quantify our products in the form of pills, do they have to be examined?

FDA: Sure. Everything should stick to the Standards for Specification, Scope, Application and Limitation of Food Additives.

We: Is there now any regulation related to GMO products?

FDA: For GMO products are generally related to GMO plants, there is still no fine institution for GMO microorganisms. Moreover, we have not yet received any application for this. But, if this really happen, we will ask the applicants to hand in the microorganism’s DNA strands they use. We will test whether any toxic substances or allergens is produced. 

We: So, is it true to say that the limitations keep GMO products from prevailing in Taiwan?

FDA: This is considered a topic of personal view. The governing departments stand on neither side in a controversial topic. But, we’ll be sure that customers have the right to know whether it is a GMO product.

We: So, what kind of data is required?

FDA: First, the effect of the product must be testified. Also, we will ask for the descriptive data about the bacterial strain, how you grow and preserve them, how you rebuilt its DNA, and whether any toxic or allergic reaction is found.

We: Is it an offence if we just make an allegation that our product is of health-giving properties?

FDA: If your product is added to medicines, you may violate the Pharmaceutical Affairs Act. If you claim that your product is of medical effects, you could end up in prison.

We: If we get the permission of commercializing health supplements, will there be an expiration date?

FDA: 5 years. If after 5 years, a new regulation is enacted, and the standard is adjusted, we will examine the product with the new standard again.

We: Is it necessary that we conduct human clinical trial?

FDA: Either in vitro or in vivo trial is acceptable. But, if your product is related to hypertension, than it will be better if you can conduct human clinical trial. Moreover, items should be labeled if it has been done with animal studies.