We contacted all 17 prenatal vitamin companies in our tests. We asked about factors that might explain why our testing found label discrepancies and certain nutrients outside of the USP tolerance range for the supplement format, whether they test both raw materials and finished products for toxic elements, whether they test finished products to verify nutrient levels, and whether they use a specific potency range for quality control. We heard back from most of the companies.
In addition to the findings and responses already noted above, we found vitamin C levels at 315 percent of the labeled amount for Vitafusion Prenatal Gummies, in excess of the USP threshold (250 percent for gummies). A spokesperson for Piping Rock, which manufactures both Vitafusion and Carlyle, said that, as shown by CR’s test results, vitamin C, especially in gummy form, naturally loses potency over time. “Therefore, on the basis of literally thousands [of] test results with this nutrient in various delivery forms . . . we include sufficient level[s] of vitamin C to guarantee 100 percent of label claim for the entire shelf life of the product, as stated on the label.” The spokesperson also said that the company reviews overage levels “to ensure that they do not come even close to established upper limit levels for the intended demographic as indicated on the product label.” The Vitafusion Prenatal Gummies packaging does include language advising consumers that “to ensure quality and potency this product is made with higher dietary ingredient levels than labeled,” and not to exceed the listed dosage.
Piping Rock also told CR that the company tests both raw materials and finished products to verify vitamin and mineral claims and amounts, referencing “USP, NIH, FDA guidance and FAQs, applicable international guidelines (i.e., Health Canada, EFSA, etc.) for quality control and related decision making.” It also shared that it has invested “millions of dollars in analytical instrumentation,” allowing it to use in-house capabilities to test both raw materials and finished products for heavy metals.
In Thorne’s Basic Prenatal, in addition to the findings already cited, we found vitamin A levels above the USP threshold. We also noted calcium levels above the USP threshold and iron levels above the UL. A spokesperson for Thorne noted the company’s “commitment to delivering labeled potency throughout shelf life” and that “certain nutrients may be formulated with scientifically justified overages,” in reference to our results for vitamin A. It also shared that the product is third-party verified by NSF International, a testing and certification organization.
For Pink Stork’s Total Prenatal + DHA capsules, we found that vitamins A, D, and B2 were all below the USP thresholds and did not match label claims, in addition to our finding that vitamin B9 was above the USP threshold, as noted above. A spokesperson for the company said that for vitamins A, D, and B2, its own testing with an independent lab found that the nutrient amounts met 100 percent of label claims. “The variation between our findings and the Consumer Reports results may reflect differences in analytical methodology or other testing conditions rather than the product’s formulation or quality.”
Walmart’s Spring Valley Prenatal Mini Multivitamin/Mineral Supplement had levels below the USP threshold for both vitamin C and vitamin E in our tests. A Walmart spokesperson told CR, “We are committed to providing safe, high-quality products, and work continuously with our suppliers to review and ensure standards are met.”
We found vitamin C levels above the USP threshold and vitamin D levels below the USP threshold in the SmartyPants Prenatal Organic Multi & Omegas gummies we tested. “At SmartyPants, product quality and safety are our highest priorities, particularly for products intended for pregnant women,” a company spokesperson said. “Our Organic Prenatal gummies use organic acerola cherry extract as the source of vitamin C. Because this is a natural botanical ingredient, some variability in vitamin C content is expected. Like many dietary supplement manufacturers, we formulate with carefully controlled overages where scientifically justified to ensure products continue to meet labeled potency throughout their shelf life, as required under FDA regulations.”
The SmartyPants spokesperson also said that “Vitamin D presents unique analytical challenges in gummy products due to the complexity of the gummy matrix,” and that “[w]hile we cannot comment on or independently interpret Consumer Reports’ testing methodology or analytical results, we remain confident in the quality, safety, and manufacturing controls behind our prenatal products.”
The Prenatal Gummies from CVS Health were found to have vitamin E levels and zinc levels above the USP threshold, and vitamin B9 (folate) levels below the threshold, at 82 percent of the label claim. “Our store brands are designed to maximize quality and safety, work as intended, and satisfy customers. While we don’t manufacture these prenatal vitamins directly, our suppliers are required to adhere to all laws and regulations. We also regularly coordinate with suppliers to ensure our products comply with state and federal requirements. While our store brand products are tested regularly by independent third parties, we’ll evaluate the results and take action if needed,” a company spokesperson said. At the time of publication, this product was no longer available at cvs.com.
We found levels of vitamins A and C above the USP threshold and vitamin B9 (folate) levels below the USP range (at 77 percent) in Amazon Basics Prenatal & DHA. “Amazon Private Brands requires all dietary supplement suppliers to manufacture products in compliance with FDA Current Good Manufacturing Practices (cGMPs). Finished products undergo rigorous quality control testing to ensure they meet labeled potency specifications throughout their shelf life. Based on our review, Consumer Reports’ test methodology is not appropriately calibrated for gummy vitamin formulations and therefore does not accurately reflect the Amazon Basics Prenatal & DHA Gummy,” an Amazon spokesperson said. CR’s scientists remain confident that the testing methodology used is appropriate for gummy formulations.
In One A Day’s Prenatal Multi Gummy, we found vitamin E levels above the USP range (at 179 percent of the labeled amount) and vitamin B9 (folate) levels below the USP range, at 28 percent, as discussed above. “For vitamin E, we intentionally apply a controlled overage at manufacture, consistent with industry standards, to help ensure that levels are maintained through the end of shelf life. As a result, tested levels may be modestly higher than the labeled amount, but they remain within levels considered acceptable from a health and safety perspective,” a One A Day spokesperson said.
Perelel’s 1st Trimester Prenatal Pack contained vitamin B9/folate at levels that exceed the USP threshold, and four other nutrients (vitamins A, C, E, and B2) in levels significantly lower than the labeled amount and below the USP threshold. “Our retest confirmed a below-label-claim result for vitamin B2 (riboflavin),” a company spokesperson said. “This is a valid finding that we previously identified as part of our standard corrective and preventive action process under 21 CFR 111, including review of raw material lot data, formulation, and manufacturing records. Perelel has since made formulation adjustments to vitamin B2 levels in current production as part of our ongoing quality improvement practices.” In regards to the other nutrients, the company stated that its results for vitamins A and E and B9 were within the USP range, noting that differences in testing factors can produce different results. “We stand behind the quality and safety of our prenatal products and remain committed to meeting or exceeding applicable FDA and USP standards. We continually evaluate opportunities to strengthen our formulations, testing protocols, and quality systems,” the spokesperson said.
Bird&Be’s Complete Prenatal Pack contained nutrients in levels that aligned with the labeled amounts, one of only two products for which CR found that to be the case. A Bird&Be spokesperson told CR, “Safety, quality, and trust guide everything we do at Bird&Be, which is why our products are made to meet or exceed rigorous safety standards. Every Bird&Be formula is developed by fertility doctors and OB-GYNs and is licensed by Health Canada, meaning it has been assessed by a federally regulated authority for safety, quality, and efficacy.” You can read more about how Health Canada regulates natural health products here.
Our testing of Needed’s Prenatal Multivitamin found that the product was below the USP threshold for vitamin C and vitamin B9 (folate). A spokesperson for Needed told CR, “Needed has a rigorous quality program, including independent third-party testing of finished goods and ongoing stability testing throughout shelf life. Our Prenatal Multi is formulated by our team of experts and manufactured in an NSF-certified facility operating under FDA cGMP. We take Consumer Reports’ findings seriously, but our own data does not show the same results, and we believe differences in analytical methodology may be a factor.”
We also reached out to Centrum, Target (Up&Up), Nature Made, and Olly about our test results but didn’t hear back after multiple requests for comment. Note: CR also tested Ritual Essential for Women Prenatal Multivitamin, but after discussion with the company, we removed it from our testing, given the complexity of the product’s capsule-within-a-capsule format.
Some manufacturers may use an independent laboratory to ensure potency or rely on in-house testing to verify label claims, rather than pursuing a third-party certification. Just four products in our tests have visible third-party certifications. According to a spokesperson for the Council for Responsible Nutrition, a trade group that represents many members of the supplement industry, “Third-party certification can be a valuable indicator of quality, but it is not the only one. Many companies choose to invest extensively in their own quality systems, supplier qualification programs, testing protocols, and brand reputation rather than pursue external certifications.”
Internal quality control systems are important, but they’re not always visible to consumers. Manufacturers aren’t required to disclose the results from their in-house testing, which can make it difficult for shoppers to assess products. “Transparency can be a problem when manufacturers handle their own verification and consumers are left trying to figure it all out,” says Eric Boring, PhD, the CR chemist who led this testing project.