Ensuring Purity for Prenatal Supplements

Understanding supplement purity is not just important – it is required by law. The critical nature of purity is magnified even further in supplements consumed during pregnancy. Heavy metals, residual solvents, pesticides, and other impurities are generally considered to be harmful to unborn babies, even in “trace” amounts. Pregnant mothers are also one of the only populations who are nearly always prescribed supplements by their physicians, in the form of prenatal vitamins. Viewed under this lens, supplement purity can be viewed as a critical public health issue.

Supplement purity starts with two major keys: ingredient traceability and analytical testing proficiency. Simply put, you need to know where your ingredients come from and how they are made. While every supplement manufacturer should have a rigorous program to qualify suppliers and ingredients, the following are just a couple basic questions that need to be answered before even considering a potential ingredient source:

1.) What are the raw materials used, and where do they come from? Are they synthesized, or from agricultural sources?  At any point do they come into contact with harmful substances? How do we know they are safe?  How do we identify them, to make sure they are what we say they are? 

2.) What inputs, equipment, and processes are used to make the ingredient? How are critical points in the process controlled?  What is the experience and expertise of the people running the processing facility? How do we ensure we are not introducing any harmful substances into the product during processing?

3.) What independent validation does the facility or ingredient have?  How do we independently prove the ingredient is fit for consumption? Are independent agencies inspecting and testing the firm for good manufacturing practices (GMP), quality documentation, and independent testing?

At Verdure Sciences, the type of firms we prefer to work with always ask these questions (and many more).  Making sure we have scientifically substantiated answers is the only way to operate. Thankfully, the days of “if it is on the COA then it must be true” are long gone. Information must be proven as cold, hard fact by suitable and reliable analytical methods, and by rigorous documentation and process validation. All ingredients, processes, and methods must be put under a microscope (figuratively and sometimes literally!)

Hot Button: Heavy Metals

One issue at the core of supplement purity, which is a hot button issue for prenatal supplements is heavy metals. Although various regulatory bodies have set limits for heavy metals in consumer products, let us be clear: there is no level of heavy metal consumption found to be safe. Yet these substances are naturally occurring at trace levels everywhere in the Earth’s crust, and must therefore be actively controlled with quality management practices. For example, Verdure requires our ingredients to meet or exceed the standards set by California ’s Proposition 65, among the lowest levels set by regulatory bodies anywhere in the world. 

While everyone may agree that independent testing of impurities is critical, the questions need to go deeper to ask HOW impurities are tested.  

Case in point: scientifically legitimate test results could falsely pass an ingredient that contains illegal levels of heavy metals. Many years ago, the standard method used for heavy metals analysis used atomic absorption spectroscopy (AAS). Yet the lowest limit of quantification with AAS can be higher than the limits set by California Prop-65. Thus, an independent lab using AAS could find metals results of ‘none detected’ when the actual amount is higher than limits set by law. If a manufacturer simply relied on the result on the certificate of analysis, and did not investigate the method used to observe the result, trouble could be on the horizon.

Luckily, now we have developed newer, better methods, such as Inductively Coupled Plasma – Mass Spectroscopy (ICP-MS) that are validated for superior precision and accuracy at very low analyte levels. These instruments are very expensive, but how does one put a price on the health of a child?