August 12 2020
Algae Biomass Summit
Algae 101 Modeling for Financial Success
The Algae Biomass Summit kicked off with their 1st Industry Spotlight Session: Algae 101 Modelling Financial Success
Valerie Harmon, Program Chair of the Algae Biomass Summit and President of Harmon Consulting Inc. opened the event.
“The algae industry is ready to provide solutions to the global food and animal feed crisis. It’s ready for climate issues, such as waste water remediation and carbon capture.
The ABS program will provide the opportunity for participants to learn more about how technology development in the algae industry will contribute to future solutions.”
Did you miss the first Industry Spotlight Session? Check out our summary of one of the wonderful panel members, Johnel Lagabon, talk below:
Johnel is a Business Development Executive for Burdock Group, an ingredient safety and regulatory consulting firm. Johnel helps ingredient innovators navigate the complex regulatory requirements to bring their products to market.
The title of his presentation:
Overcoming U.S. Regulatory Hurdles for Novel Food, Feed, and Dietary Supplement Ingredients
Food regulation apply to humans and animals. Any ingredient or additive is subject to food regulation. Food regulations apply to dietary supplements, but not all dietary supplement regulations apply to food! Confusing, we know, that’s why Burdock Group is there to help us out. Regulators do not have distinct categories for words that marketers commonly use, such as nutraceuticals, aquaceuticals, functional foods, etc. Often nutraceuticals and aquaceuticals are subject to dietary supplement regulations.
Some people believe that once something is GRAS Certified it has been approved, but Johnel tells us this is not entirely true. What actually is approved is NOT the ingredient, but the ingredients safe use.
Example: If there is GRAS for Spirulina that has data to show it is safe for human consumption at 10 mg/kg a day.
This is not GRAS example:
- Using Spirulina at 20 mg/kg a day, which exceeds the acceptable daily intake.
- Using Spirulina as a cattle feed, as safety data does not support safe use in cattle.
Two pathways for novel ingredient compliance in the US
- Food Additive Petition (FAP)
- Generally Recognized As Safe (GRAS)
Food Additive Petition is an FDA approval and rule making process. It requires scientific data approval that fulfills the criteria of something called the “Red Book”. Once you’re fulfilled that criteria, drafted you narrative for safety, you then submit your documents to the FDA. They will review everything, and after all of the steps, at the end of the day you will hopefully have an approved food additive. This entire process can take between 3-8+ years. The estimated cost of an FAP with studies is $380,000-$700,000.
Generally Recognized As Safe still requires safety steps, but slightly different approval process. How do you meet the general recognition of safety? First, publish all of your safety data in a peer reviewed journal. This allows scientists to review and comment on the accuracy and quality of your data. Second, there is an expert panel that reviews your documents. Once that is approved you’re good to go! You are compliant with federal law and you ingredient is Generally Recognized As Safe. Congrats! The estimated costs with studies of GRAS is $380,000. This process typically takes 20-26 months. Johnel noted later in the Q&A that if you use a different algae production process, or algae cultivation process it might not mean that your algae strain is GRAS.
GRAS is often the best option for novel ingredients. Why is this?
- Shorter timeline, 3-8+ years vs 20-26 months.
- GRAS safety study requirements more flexible. The quality is expected to be the same, but the choice of studies if left to the discretion of qualified experts.
- Lower cost. $380,000-$700,000 vs $380,000.
Which Path Works Best of My Novel Ingredient? Contact Burdock Group for help bringing your novel ingredient to market!
Other speakers in the Algae 101 session included:
- Tom Byrne, CarlsonSV
- James Drage, Algaculture Project
- David Ramjohn, AlgEternal
- Johnel Lagabon, Burdock Group
Maya Skubatch, Wilson Sonsini Goodrich & Rosati
Visit the Algae Biomass Organization website for more information on the 2020 Algae Biomass Summit.
About Industrial Plankton:
Industrial Plankton designs and develops algae bioreactors systems for commercial, research, and industrial scale algae production. To see our line of photo-bioreactor technology please visit our products page.