Adjuvia Astaxanthin Compliance and Allergen Statements
Allergen and Side Effects Statement
Sustainable Nutrition’s Astaxanthin is sold under the brand name Adjuvia.
Astaxanthin can provide several health benefits: The FDA has characterized astaxanthin as GRAS, which means generally recognized as safe.
The product can result in several possible side effects.
People who are allergic to lobster, shrimp or any other seafood should not take astaxanthin since astaxanthin is rich in these foods and it is possible the allergy includes sensitivity to this molecule.
Astaxanthin can lower blood pressure.
Hormonal changes may be among Astaxanthin side effects. The supplement may react negatively with hormone-altering medications. It may interact with herbs, including saw palmetto, black cohosh and vitex, which are herbs commonly used in altering the body’s hormone level.
Astaxanthin can lead to breast enlargement for those men who are taking the supplement.
It is not recommended for pregnant women because of potential effect on hormone levels.
Allergic reactions can include difficulty in breathing and hives.
Please note that our labeling includes clear reporting of the contents including Astaxanthin.
Pesticide residue levels on food are regulated by both the FDA and the Environmental Protection Agency (“EPA”). Under the FIFRA, the EPA is responsible for regulating the use of pesticides and for establishing tolerances (or exemptions from the requirements for tolerances) for residues of pesticide chemicals in food commodities.
As part of Sustainable Nutrition’s stewardship of its processes and products, we constantly monitor and test and have 3rd party testing to assure that our products are within regulated levels of pesticides and other hazards in our products as regulated by the FDA ad the EPA.
Raw Materials Flow Chart and Country of Origin/extraction statement
We procure raw algae of Haematococcus pluvialis from one of several producers of this algae. One is in located in China. One has multiple manufacturing sites, in Japan, the United States and Sweden, another is based in Israel and another also in the United States. This material is procured with a certificate of analysis.
We procure food grade ethanol from US suppliers.
We procure MCT, safflower and peppermint oil from US and Mexico suppliers.
We do not do an extraction: we use a patented process using heat, mechanical energy and chemical solvents to reduce the biomass to less than 100 nm, in which case the lipids are liberated along with the astaxanthin molecule, and a lipid rich nano emulsion oleoresin is produced.
We then add a carrier oil and apply temperature and vacuum to remove most of the ethanol.
This oil is then consolidated into “stock oil” lots and controlled while a sample is taken and sent to a third-party lab for full spectrum analysis, including pesticides, solvents, metals, chemicals, biocides, microbiologic, pathogens and mycotoxins and astaxanthin concentration.
When this is completed, a formulation for this lot is calculated and the product either goes into tincture bottles or is encapsulated in gel caps.
Residual Solvents Statement
Regulations for residual solvents analysis: ICH Q3C & USP
Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques. Appropriate selection of the solvent for the synthesis of drug substance may enhance the yield, or determine characteristics such as crystal form, purity, and solubility. Therefore, the solvent may sometimes be a critical parameter in the synthetic process.
In 1988, the United States Pharmacopoeia (USP) provided control limits and testing criteria for seven organic volatile impurities (OVIs) under official monograph USP Residual Solvents. The compounds were chosen based on relative toxicity and only applied to drug substances and some excipients. They have since extended the compound list in General Chapter Residual Solvents, and harmonized their efforts by aligning limits with the International Council for Harmonization (ICH) guidelines ICH Q3C Guideline for Residual Solvents.
Allowable limits or Permitted Daily Exposure (PDE) for residual solvents are defined in ICH Q3C. The PDE is based on the toxicity of the solvent. Solvents are defined into three class:
- Class 1 solvents: Solvents to be avoided—known human carcinogens, strongly suspected human carcinogens, and environmental hazards.
- Class 2 solvents: Solvents to be limited—on-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity. Solvents suspected of other significant but reversible toxicities.
- Class 3 solvents: Solvents with low toxic potential—solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDEs of 50 mg or more per day.
Q3C — Tables and List Guidance for Industry States: It is considered that amounts of these residual solvents of 50 mg per day or less (corresponding to 5,000 ppm or 0.5 percent under Option 1) would be acceptable without justification. Higher amounts may also be acceptable provided they are realistic in relation to manufacturing capability and good manufacturing practice (GMP).
Sustainable Nutrition, Inc. uses a class 3 solvent, food grade ethanol, in its manufacturing process, which is not entirely removed from the finished products. Sustainable Nutrition have 3rd party independent lab testing using headspace chromatography on all lots to determine residual amounts of ethanol in our materials. The only solvent we use is food grade ethanol. An adult taking two one half ml gel caps with 12 mg of astaxanthin would consume less than 50 mg per of ethanol per day.
California Proposition 65 Compliance Statement
As part of Sustainable Nutrition’s product stewardship and regulatory compliance efforts, we continuously monitor potential regulatory, safety, health and environmental impacts of using our products. As such, we would like to inform you regarding the new requirements of the regulation concerning California Proposition 65.
California Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, became law in November 1986.
Proposition 65 requires businesses to provide warnings to Californians (and others doing business in the State of California) about significant exposures to chemicals that are known to cause cancer, birth defects or other reproductive harm.
On August 31, 2016, the State of California Office of Environmental Health Hazard Assessment (OEHHA) adopted certain amendments to Article 6, Clear and Reasonable Warnings for California Proposition 65 which become effective on August 30, 2018. For more information on warnings, go to www.P65Warnings.ca.gov.
The products manufactured by Sustainable Nutrition do not contain the substances regulated by California Proposition 65 in concentrations resulting in exposures above the safe harbor levels determined by OEHHA. As such, these products are not required to have the California Proposition 65 warning labels.