The DS-01 Daily Synbiotic from Seed Health is a supplement combining probiotics and prebiotics (a synbiotic). Because the dietary supplement industry often shows variability in quality and efficacy, verification of contents is paramount for products containing live organisms like probiotics. Consumers seek confirmation that what is on the label matches what is in the bottle, especially given the complex science involved in maintaining microbial viability.
The Necessity of Independent Testing in Probiotics
The regulatory structure for dietary supplements in the United States does not require products to receive pre-market approval from the Food and Drug Administration (FDA). Responsibility for safety and accurate labeling falls primarily on the manufacturer. This framework makes consumer reliance on robust quality assurance measures, like independent third-party testing, necessary.
In the context of probiotics, this external verification focuses on three main areas of quality control:
- Strain identity, which confirms that the specific bacterial strains listed on the label are present, as health benefits are highly strain-specific.
- Potency, which ensures the advertised quantity of live microorganisms—often expressed in Active Fluorescent Units (AFU) or Colony-Forming Units (CFU)—is accurate.
- Purity, which involves testing for common contaminants such as heavy metals, pesticides, and other unwanted microbes to confirm product safety.
Seed Health’s Specific Third-Party Validation Framework
Seed Health uses an extensive, multi-layered quality control process that goes beyond industry minimums. The process begins with rigorous internal Quality Control (QC) followed by mandatory external validation performed by independent, accredited laboratories.
A primary focus of this third-party testing is confirming purity and safety through lot-to-lot testing. This includes screening for over 500 unique pesticides (such as glyphosate and AMPA) and an extended panel of heavy metals. The final product is also tested to ensure it is free of more than 20 allergens, adhering to standards defined by the European Food Safety Authority (EFSA).
For identity assurance, Seed employs whole-genome sequencing on the microbial strains. This advanced technique genetically verifies the precise species and strain designation of the organisms present and confirms the absence of any antibiotic-resistant genes. Potency verification is carried out using flow cytometry, which measures the viable cell count in Active Fluorescent Units (AFU). This method is considered more accurate than the traditional CFU measurement because it counts all viable cells.
A further level of validation is survivability testing, which models the product’s journey through the human digestive tract. This is accomplished using the Simulator of the Human Intestinal Microbial Ecosystem (SHIME®), a sophisticated system that mimics the physiological conditions of the gut. These tests assure that the live microorganisms successfully transit the stomach acid and reach the colon.
Manufacturing and Supply Chain Integrity
The commitment to quality extends beyond laboratory testing into the manufacturing environment. Production facilities adhere to both U.S. and European protocols, including Current Good Manufacturing Practices (cGMP) and Hazard Analysis and Critical Control Points (HACCP). These certifications ensure the synbiotic is produced consistently with high standards for identity, purity, and composition.
Maintaining the viability of the live organisms requires careful consideration of environmental factors throughout the supply chain. Stability testing verifies that the product retains its guaranteed potency (measured in AFU) through the entire shelf life. This verification includes thermostability testing, which subjects the product to extreme heat and humidity to simulate potential stresses during shipping and storage.
To protect the delicate probiotic strains from the destructive forces of stomach acid, the product is housed in a proprietary capsule-in-capsule delivery system called ViaCap®. This system ensures the inner capsule containing the probiotics is released in the lower small intestine, allowing the organisms to survive the turbulent digestive process.