At Hiya, we understand that nothing is more important than safety and quality when it comes to your child's health. As parents ourselves, we deeply care about every single detail, and hold ourselves to the highest standards to ensure our products are safe and healthy for kids.
That's why we continuously collaborate with our supply chain partners to build best- practice quality checks and improvements throughout our production process. We test each lot of product at multiple points along the supply chain. This testing includes submitting EVERY batch of every product for contaminant testing, including heavy metals and microbial testing - a practice that helps leads the way around industry transparency. Any levels are also below even the most stringent of state standards, including Prop 65, so you can be sure you're always giving your kids products deemed safe and nutritious.
A Closer Look at Testing
Heavy Metals:
Hiya contracts with qualified 3rd party laboratories who use validated methods to test every batch of every product produced for heavy metals including, lead, mercury, arsenic, and cadmium. The most widely accepted approach for testing elements, whether they are heavy metals such as lead, arsenic, cadmium, and mercury, or other elements such as iron, calcium, or selenium is a technique known as coupled plasma mass spectroscopy (“ICP-MS”)
Inductively Coupled Plasma:
Vitamin samples are digested to ensure their complete decomposition to elemental form. Once digested, samples are injected into an ICP instrument as a plasma that flows past a detector. When the sample passes the detector, the detector will record changes from the baseline signal due to the presence of the sample. These changes, when compared to a standard of known material and concentration can be measured and quantified as long as the signal they create is above the limit of detection for the testing method.
Limit of Detection:
The limit of detection is measured as a shift from a baseline level of the detector with no sample present and each individual element has its own specific limit of detection. In general, to be quantifiable in limit test, such as heavy metals by ICP, each metal must generate a signal that is at least 3 times the signal of the baseline. If the element does not elicit a signal from the detector that is at least 3 times the signal of the baseline noise, then it cannot be detected at a measurable amount by the test. In other words, the limit of detection for each heavy metal that Hiya tests is the lowest quantity or concentration of the metal that can be reliably detected by the testing method used. Method Limits of Detection for Hiya Heavy Metals Testing:
Element | Limit of Detection in Parts Per Billion (PPB) |
---|---|
Arsenic (As) | 3.4 ppb |
Cadmium (Cd) | 0.33 ppb |
Lead (Pb) | 2.1 ppb |
Mercury (Hg) | 0.28 ppb |
Data reporting:
If there is no signal detected then the laboratory will report the result as “undetected” or as “less than a specification value,” where the specification value is a number that the lab has put into their data software. If there is any signal from the detector that is above the limit of detection the laboratory will be able to report the specific value.
So for the example Certificate of Analysis (“COA”) below - if a laboratory COA reports Lead as “U” (undetected), and taking into consideration the laboratory established limit of detection of lead as 2.1ppb (from above), this specific lab is reporting on its COA that down to a concentration of 2.1 ppb there was no lead detected.
Even where the ICP registers a 'detectable' level that can reported as a specific value, Hiya establishes rigorous specification limits on heavy metals to ensure that no detectable level presents a safety concern.
If any level is above Hiya's established specification levels for the product, then the product will be immediately flagged as out of specification (OOS) and not permitted to be released into distribution.
We Comply with The Most Stringent of Standards
It is well established that heavy metals are naturally and unavoidably found in the soil of the healthiest foods we can eat — including fruits, vegetables, and grains. In other words, heavy metals occur naturally in the environment in the soil, air, and water. You'll often find heavy metals in a wide variety of some of the healthiest foods, including spinach, carrots, beets, and so much more. So it is natural that many of the healthiest foods you eat will include heavy metals.
To ensure adequate safety, federal and state regulators establish limits on heavy metals in packaged foods so that any detectable levels are so low so as not to post a health risk to the consumer.
Currently the most stringent limits on heavy metals in consumer products mandated in the US are set by California's Proposition 65 rule. Prop 65 has mandated the above limits for heavy metals exposure. Prop 65 limits are established to reflect those extremely low level detectable levels that do not pose a health risk.
Hiya follows rigorous standards to ensure that any heavy metals are completely undetectable or never more than the de minimis detectable level established under Prop 65's rigorous standards.
In addition to heavy metals testing, finished products are rigorously tested for purity and potency, with detailed Certificates of Analysis (COAs) maintained for every batch. Hiya also conducts visual inspections of all products at our warehouse and performs additional heavy metal testing as needed. Our commitment to safety extends to compliance with California Prop 65, which sets the most stringent nationwide rules for product safety.
Now that you have learned about detection limits in testing and specification limits required for Hiya's products, here is a look at a real third-party lab test, performed on Hiya's products:
We Track Results Regularly
By selling exclusively direct-to-consumer, we can track every batch (which is practically never done) and can review individual test results upon request. If you want confirmation of your unique batch's third-party lab tests, simply email support@hiyahealth.com.
Above are batch results from our third-party testing facility that demonstrate how all relevant levels meet even the strictest federal and state standards.
This level of detail leads the way in our industry and demonstrates our unwavering commitment to the safety and quality of our products. We don't just meet legal requirements - we exceed them. Our commitment to safety and quality is at the core of everything we do, ensuring that every product we deliver is safe, effective, and of the highest quality.
Our Rigorous Quality Standards:
- Overseen by our dedicated Head of Product
- Governed by detailed Standard Operating Procedures (SOPs)
- Continuous collaboration with supply chain partners for quality checks and improvements
Manufacturing Excellence:
- On-site raw material testing
- Finished product testing for purity and potency
- Partnerships exclusively with GMP-certified manufacturers
- Detailed Certificates of Analysis (COAs) are maintained for every batch
Third-Party Testing:
- Every lot tested by independent, reputable labs
- Comprehensive screening for heavy metals and microbial contamination
Additional Safety Measures:
- Visual inspection of all products at our warehouse
- Compliance with California Prop 65, the most stringent nationwide rules
FAQs
Our team of vitamin experts and scientists has answers.
Does Hiya test for heavy metals like lead, arsenic, and cadmium?
Yes, Hiya tests for heavy metals, including lead, mercury, chromium, arsenic, and cadmium in every batch of products.
How often does Hiya conduct heavy metal testing?
Hiya conducts heavy metal testing on every batch of every product that is produced.
Who performs the heavy metal testing for Hiya?
Hiya uses independent, reputable third-party labs, such as Kappa Laboratories and PDA Laboratories Inc., for testing, both of which are accredited ISO/IEC testing laboratories with affiliations with the FDA and other regulatory bodies.
Is Hiya compliant with California Prop 65?
Yes, Hiya complies with California Prop 65, which sets the most stringent nationwide rules for product safety.
Can I review the test results for my specific order?
Yes, our vitamin concierge would love to help you. You can request confirmation of your individual order’s third-party lab test results by emailing support@hiyahealth.com
Are Hiya's manufacturing facilities GMP-certified?
Yes, Hiya partners exclusively with GMP-certified manufacturers who submit to regular FDA inspections and third-party audits.
Does Hiya conduct any additional testing beyond third-party lab tests?
Yes, Hiya also conducts visual inspections of all products at their warehouse and performs additional contaminant testing as needed.
How can I be sure that Hiya's products are safe for my child?
Hiya is a leader in the industry, going above and beyond standard quality assurance practices. Hiya implements rigorous quality control measures, including third-party testing of every batch, compliance with strict safety standards, and transparency in sharing test results. We do not make anything we wouldn’t give our own kids.
What should I do if I have concerns about my Hiya order?
If you have any questions or concerns about your specific order, you can contact Hiya's vitamin concierge at support@hiyahealth.com for assistance.