4 Factors for Supplement Safety: Inside FullWell's Standards

Our founder, Ayla, created FullWell to give her clients a supplement she could genuinely, 100% get behind. Unfortunately, nothing on the market checked all of her boxes, so she rolled up her sleeves and set to work to make an evidence-based, effective, and high-quality supplement herself. After almost two decades of education, research, and clinical practice, and with the support of scores of expert practitioners, she formulated our flagship Women’s Prenatal, not only for her clients but the rest of the world.

Her approach was unconventional for the time.

When Ayla began formulating our Women’s Prenatal, she chose to not only look at the whole person she was making it for - that is, taking into account the context of their environment and individualized health factors - but she was also intent on meticulously monitoring the entire production process. So many supplements can cause more harm than good, mainly because something falls short somewhere along the production line. Ayla was adamant that FullWell would not only be of the highest quality possible but also be as safe as it was effective once the bottle hit the hands of its consumers. She has maintained this same level of oversight for every product launched since. 

Any healthcare practitioner worth their salt is concerned with the safety of the supplements they prescribe.

We look at four major safety factors before recommending our clients, patients, and community invest their time and money in a supplement.

So what are these four major safety factors?

1. QUALITY

What form are the nutrients in, and are they bioavailable? How are contaminants assessed and reduced? Does each serving meet the label claim consistently? (It is extremely difficult to ensure that you get what the label says you will in each serving, and the hurdles become more numerous when you add more ingredients of various weights and sizes).

2. SOURCING

Does the brand know its raw ingredient suppliers? Do the raw ingredient suppliers share the same commitment to quality and safety that we do? 

3. MANUFACTURING

Is the manufacturer GMP-certified (Good Manufacturing Practice) and FDA-registered? How is safety ensured, including cross-contamination with allergens?

4. TESTING

Even after painstaking research and due diligence concerning quality, sourcing, and manufacturing, has the final product been tested by an objective, independent third party and cleared for consumption? Is the company willing to share those results with their customers?

We want everything you put into your body at any stage of life (especially preconception, pregnancy, or breastfeeding) to be safe for you and baby. So let’s break these four factors down just a bit further so you understand where we’re coming from.

QUALITY

Suppose you have read any of our KnowledgeWell posts on individual nutrients or looked through our ‘Ingredients at a Glance’ section for each FullWell product. In that case, you know that we are confident in our research of what is needed to build the optimal foundation for conception, pregnancy, and postpartum recovery. 

We use the most bioavailable forms of each vitamin and mineral in our formulation, meaning they are the most easily absorbed by the body. Thiamin (vitamin B1) and magnesium are great examples of this. In our research and development of our Women’s Prenatal, we felt that the form of vitamin B1 that we used was not only the most researched in pregnancy but was also the most stable (which is essential when creating a formulation for a prenatal). Other forms of vitamin B1 are associated with stomach upset, so we were trying to balance how well the formula would be tolerated by our customers, in addition to considerations regarding its bioavailability and overall effectiveness. Therefore, our formulation also includes magnesium glycinate, the most well-tolerated form of magnesium (unlike other forms that can cause stomach issues), and has the added benefit of being well absorbed by the body.

Ingredient quality shouldn’t be overlooked when it comes to formulating a product. FullWell Fish Oil is created using sustainably sourced, wild-caught sardines and anchovies from a Friend of the Sea certified fishery (which means both ethical and sustainable practices are undertaken to ensure the health of the fish supply). This product has a phenomenally low TOTOX score, which measures the total oxidation of the fish oil. Our TOTOX score is 11.2, well below the value of 26 set by the Global Organization for EPA and DHA omega-3. It’s worse to take an oxidized fish oil than to take none at all! TOTOX scores are just another way we prioritize ensuring our products' safety and efficacy.

With 23+ ingredients in our Women's Prenatals and Men’s Multivitamins, it is a challenge to get consistency in every capsule, which is why we use rice hulls to help (and it only ends up being a tiny amount that is used during this process.) Our rice-based flowing agent helps us ensure that there are consistent amounts of nutrients in each and every capsule. (This was also why we chose a capsule delivery system versus powder for our prenatal, as it's incredibly difficult to guarantee what’s in each serving scoop). We are confident in the safety of this ingredient as it is not only organic but goes above and beyond the industry standard to ensure safety and quality in every aspect. We test every single batch for identity and contaminants, including heavy metals (see ‘Testing’ for more information).

SOURCING

We work exclusively with high-quality ingredient suppliers who share our commitment to quality and safety. If they cannot provide proper validation of the raw product, we will pass, sometimes at the cost of production. Ayla has never once been afraid of throwing a wrench in the entire operation to stop it if something isn’t right. After all, FullWell was created in the first place to ensure quality and safety throughout the ENTIRE supply chain. We’re uninterested in less-than-ideal sourcing, even if it’s at our own expense.

We’ve noticed a recent trend in customers reaching out to us asking where we source our ingredients. We think it has to do with how some other well-known companies are choosing to market their products with a focus on traceability above all else. Though we have considered sharing where we source our ingredients, we ultimately decided to go a step further and share information about the quality and safety of our end product. The honest truth is that sometimes, though rarely, we change suppliers if they don’t meet our standards. So, though the origin of each ingredient may change, the quality and safety (meaning microbial contaminants, heavy metals, etc., fall below testing limits) are always maintained. This is how we define transparency, and we genuinely believe that ensuring you have the BEST final product is the most important thing. We pride ourselves on building personal relationships with everyone involved to keep a close eye on what eventually turns into the FullWell products we want you to put your trust behind.

MANUFACTURING

Trust is the basis of every aspect of production. We build deep, long-standing relationships with our manufacturers. Moreover, FullWell is manufactured in the United States under the Good Manufacturing Processes (cGMP). As a result, our supplements have an exceptionally low risk of contaminants or cross-contamination. All our facilities have achieved the highest certification and recognition for quality and safety.

Our manufacturing facility does not exclusively produce gluten-free products. However, the cleaning procedures for a cGMP-certified facility are far more extensive than a food product production facility. It includes removing organic materials from product contact surfaces and doing ATP swabbing to ensure the surfaces are clean and uncontaminated. So, the risk of cross-contamination of any kind, at the start, is extremely low. We then test the final product in-house and confirm via an independent, certified lab that the product is free from common allergens and contaminants, including salmonella, arsenic, lead, dairy, gluten, wheat, tree nuts, eggs, soy, and corn, to name just a few.

TESTING

Purity is paramount. In 2015, The New York State Attorney General’s Office removed store brand supplements from the shelves of supplement retailers like GNC, Walmart, Walgreens, and Target after they were found to be packed with fraudulent — and in some cases hazardous — ingredients (like asparagus powder and house plants). In addition, many of the supplements didn't even contain what they said they contained at all! Can you believe it?! 

The supplement industry is highly regulated regarding supplement safety. However, the organizations that police it are often overwhelmed and overworked. This means that there is often a degree of self-policing that brands need to do to uphold these standards, and this is something that we take seriously at FullWell.

FullWell performs in-house testing at our GMP and FDA-certified facility and then verifies those results via a third-party lab for every single batch to confirm ingredient identity and ensure our supplements are within Prop 65 recommended limits of contaminants (including heavy metals and glyphosates). However, as many manufacturers have told us, this (again) is NOT standard industry practice. We could save a lot of time and money by forgoing this self-imposed process of double testing every batch. Therefore, we don’t work with those manufacturers. We only release our product when it has passed every standard and are committed to ensuring our test results are always readily available to all our customers.