11.17.16
Algae Health Sciences, Inc., Irvine, CA, a subsidiary of BGG, has submitted a new New Dietary Ingredient (NDI) Notification to the U.S. FDA for its flagship product AstaZine Natural Astaxanthin. This new filing builds on a previous NDI in late 2015 for the use of AstaZine as a bulk dietary ingredient at a dose that does not exceed 12 mg of astaxanthin per day; the new NDI has been filed at a dose that does not exceed 24 mg of astaxanthin per day for a period of 30 days.
The new 24 mg per day dosage is the first in the astaxanthin industry over 12 mg per day. “Based on published studies we generally recommend a dosage of 4-12 mg per day over longer periods; however, we are aware that a growing number of people are voluntarily dosing at well over the 12 mg upper dosage range,” said Lixin Ding, PhD, COO of AlgaeHealth. “In particular, many athletes report that they get better results in the 24 mg per day dosage range.”
Published clinical research on natural astaxanthin has seen a wide range of dosages. For example, research on immune health has demonstrated results at 2 mg per day, while there have been studies done at levels above 12 mg showing benefits in a few different areas, according to the company. In particular, the human studies on astaxanthin’s benefits for cardiovascular health have shown positive results above 12 mg per day.
“While we would have preferred not to have the 30 day stipulation, we’re nevertheless happy to have something new to offer in the U.S. market,” said Joe Huff, CEO of AlgaeHealth’s North American operation. “We’re always thinking of ways to innovate and wanted to give the market a new option regarding dosage. In particular we see two excellent recommendations for a 24 mg dosage during a defined 30-day period:
AstaZine is the world’s first astaxanthin extracted from certified organic Haematococcus pluvialis microalgae. AstaZine is produced in a 100% glass tube photobioreactor (PBR) closed system on the world’s second largest natural astaxanthin farm. AlgaeHealth produces AstaZine in a variety of forms including organic 5% powder; 5%, 10% and 20% oleoresin; 2% water soluble powder; 2.0% and 2.5% microencapsulated beadlets.
The new 24 mg per day dosage is the first in the astaxanthin industry over 12 mg per day. “Based on published studies we generally recommend a dosage of 4-12 mg per day over longer periods; however, we are aware that a growing number of people are voluntarily dosing at well over the 12 mg upper dosage range,” said Lixin Ding, PhD, COO of AlgaeHealth. “In particular, many athletes report that they get better results in the 24 mg per day dosage range.”
Published clinical research on natural astaxanthin has seen a wide range of dosages. For example, research on immune health has demonstrated results at 2 mg per day, while there have been studies done at levels above 12 mg showing benefits in a few different areas, according to the company. In particular, the human studies on astaxanthin’s benefits for cardiovascular health have shown positive results above 12 mg per day.
“While we would have preferred not to have the 30 day stipulation, we’re nevertheless happy to have something new to offer in the U.S. market,” said Joe Huff, CEO of AlgaeHealth’s North American operation. “We’re always thinking of ways to innovate and wanted to give the market a new option regarding dosage. In particular we see two excellent recommendations for a 24 mg dosage during a defined 30-day period:
- A loading phase for the first 30 days of use for a new astaxanthin consumer to allow the astaxanthin to concentrate throughout the body
- For athletes during the month leading up to an important event
AstaZine is the world’s first astaxanthin extracted from certified organic Haematococcus pluvialis microalgae. AstaZine is produced in a 100% glass tube photobioreactor (PBR) closed system on the world’s second largest natural astaxanthin farm. AlgaeHealth produces AstaZine in a variety of forms including organic 5% powder; 5%, 10% and 20% oleoresin; 2% water soluble powder; 2.0% and 2.5% microencapsulated beadlets.
