How to Educate Patients About Safety, Regulation, and Quality of Vitamins & Supplements

Dietary supplements are more popular than ever in the United States, with millions of adults taking vitamins, minerals, herbs, and sports products daily. Yet despite the perception that these items are closely regulated, supplement oversight differs dramatically from traditional pharmaceuticals. Understanding these gaps—along with the role of third-party testing and who actually benefits from supplementation—is essential for improving patient safety and supporting evidence-based counseling.

How Are Supplements Regulated and Why Does it Matter?

Dietary supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which defines them as a separate category of food rather than drugs. Consequently, manufacturers are not required to prove safety or effectiveness to the FDA before filing most products on the market.¹ As the FDA states, "Under DSHEA, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed."²

As a result, the FDA’s role is largely reactive, where it responds by sending warning letters, inspecting facilities, and coordinating recalls that are initiated due to safety problems.² Manufacturers still have to guarantee that their products do not harm consumers, that they aren’t polluted with any contaminants, and that labels are accurate, but the lack of vigorous implementation creates a wide range of product quality.

These limitations have contributed to recurring concerns involving mislabeling, contamination, and adulteration. A PLoS ONE analysis of 29 herbal supplements found up to 120% variability in active components between bottles and detected fungal contamination in nearly 60% of samples.³ Such findings highlight the need for independent verification mechanisms.

What Is Third-Party Testing?

Since supplements do not require pre-market approval; most healthcare professionals advise patients to use only those supplement products that have been verified by an independent third party. Third-party testing organizations such as U.S. Pharmacopeia (USP) and NSF International carry out independent evaluations of products for:

Identity: Does it contain the ingredients listed?

Potency: Are the amounts accurate?

Purity: Are contaminants (heavy metals, microbes, undeclared drugs) absent?

Manufacturing quality: Does the facility follow Good Manufacturing Practices (GMPs)?

According to USP, the USP Verified Mark confirms that a supplement “contains the ingredients listed on the label, does not contain harmful levels of specified contaminants, and has been made according to GMPs.”⁴ However, third-party certification does not validate clinical effectiveness only product quality.

Companies like Canomiks have initiated programs like WhatToTrust to help test and verify safer supplements for consumers.

This growing movement toward transparency was highlighted in a recent Pharmacy Times interview. “WhatToTrust is again a Canomiks solution. This time, we are actually helping consumers make informed buying decisions. What we do at WhatToTrust is take a dietary supplement, functional food, or functional beverage product—it could be a multivitamin, a shake powder, a tea, or anything that has a functional effect—and evaluate what kind of science has been used in the development of that product.” Leena Pradhan-Nabzdyk, PhD, MBA, CEO and co-founder of Canomiks stated. “We want to be transparent. We want to bring truth, transparency, and trust to this industry.”

Who Actually Needs Supplements?

Supplements are appropriate and evidence-supported for certain populations, but most healthy adults may not benefit from routine vitamin use. The U.S. Preventive Services Task Force (USPSTF) concludes that the evidence is not enough to support the use of multivitamins as a method of primary prevention of cardiovascular disease or cancer in community-dwelling adults. In addition, the agency advises not to use beta-carotene or vitamin E for that purpose.⁶

People who may benefit from the use of supplementation include:

Pregnant individuals or those trying to conceive: 400–800 mcg folic acid daily to reduce neural tube defects.⁷

Patients with documented deficiencies: e.g., iron, vitamin B12, or vitamin D deficiency confirmed by lab testing.

Vegans/vegetarians: vitamin B12 supplementation is commonly needed.

Older adults or those with malabsorption conditions: may require targeted supplementation based on clinical assessment.

However, quality matters just as much as need, making third-party verification essential.

Pharmacists Need to Encourage and Educate Patients

Pharmacists, while counseling patients about supplement intake, must initiate the conversation with a question regarding the reason for the patient's use of the product. Is the patient treating a verified deficiency or just wanting to enhance his/her general health? This clarifies the need for the recommendation and thus, avoids the patients from taking supplements that are unnecessary or in which they are already duplicating. Subsequently, pharmacists may direct patients to use products that have been verified by third parties, for example, those certified by USP or NSF, which ensure more accurate ingredient, purity, and safe manufacturing.

Patients also often need to reminded that “natural” is not necessarily “safe.” Supplements can be risky in some cases, such as contamination, adulteration, and possible drug–supplement interactions. Pharmacists have to support nutrition-first approaches because a well-balanced diet is still the most efficient and trustworthy way to satisfy most nutrient requirements. Supplements are not FDA-approved treatments, so it is helpful in setting up real expectations, most of the health or disease-prevention claims made by the marketers are not supported by strong clinical evidence, and patients should be aware of the limitations as well as the potential benefits.

Conclusion

Supplements are essential in some cases for certain groups of people, however, due to the absence of a pre-market FDA control and quality that varies and is not always consistent, consumer education is very necessary. If there is unambiguous direction, pharmacists can assist patients to understand complicated labels, stay away from harmful products, select verified brands, and use supplements if there is evidence. As Pradhan-Nabzdyk stated, the objective is to rebuild consumer trust by "introducing truth, transparency, and trust to this industry."⁵

REFERENCES

1. NIH. Dietary supplement health and education act of 1994 public law 103-417 103rd congress. Nih.gov. Published 2017. Accessed November 21, 2025 https://ods.od.nih.gov/About/DSHEA_Wording.aspx

2. Center for Food Safety and Applied Nutrition. Information for Consumers on Using Dietary Supplements. U.S. Food and Drug Administration. Published 2019. Accessed November 21, 2025 https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements

3. Veatch-Blohm ME, Chicas I, Margolis K, Vanderminden R, Gochie M, Lila K. Screening for consistency and contamination within and between bottles of 29 herbal supplements. PLoS One. 2021;16(11):e0260463. Published 2021 Nov 23. doi:10.1371/journal.pone.0260463

4. Dietary Supplement Manufacturing - USP Verified Mark | USP. www.usp.org. https://www.usp.org/verification-services/verified-mark

5. Valletti D, Pradhan-Nabzdyk L. Bringing Truth, Transparency, and Trust to the Supplement Industry. Pharmacytimes.com. Published October 15, 2025. https://www.pharmacytimes.com/view/bringing-truth-transparency-and-trust-to-the-supplement-industry

6. US Preventive Services Task Force, Mangione CM, Barry MJ, et al. Vitamin, Mineral, and Multivitamin Supplementation to Prevent Cardiovascular Disease and Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2022;327(23):2326-2333. doi:10.1001/jama.2022.8970

7. US Preventive Services Task Force, Barry MJ, Nicholson WK, et al. Folic Acid Supplementation to Prevent Neural Tube Defects: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA. 2023;330(5):454-459. doi:10.1001/jama.2023.12876