US “flooded” with questionable quality supplements, ACCP calls for more FDA regulation

26 Jan 2022 --- Regulatory bodies in the US do not have enough oversight of nutraceuticals, leading the market to be flooded with questionable supplements, which create insecurity for healthcare providers, patients and manufacturers, the American College of Clinical Pharmacology (ACCP) is arguing.

Coupled with the organization’s position that healthcare staff lack critical knowledge on supplement products, the ACCP is calling for action to improve industry and education for professionals and consumers alike.

“Among the many products available to customers and patients alike, there is little or no guidance as to what products adhere or constitute good quality products,” Oliver Grundmann, clinical professor and director at the college of pharmacy, University of Florida and ACCP fellow, tells NutritionInsight.

The ACCP argues that healthcare professionals are reluctant to discuss the use of dietary supplements with patients because of the lack of regulation, clinical data and mistrust of “unproven, unreliable and variable quality” of dietary supplements flooding the market.

“The current lack of regulatory oversight and transparency has created insecurity for healthcare providers, patients and manufacturers alike.”The ACCP is calling for more oversight by the FDA.

Challenging landscape
Currently, the US regulatory framework is based on the 1994 Dietary Supplement Health and Education Act (DSHEA), which grants the US Food and Drug Administration (FDA) and Federal Trade Commission the authority to oversee specific aspects of dietary supplement regulation.

These include good manufacturing practice (GMP) and labeling standards, the ACCP outlines. The FDA “has the burden of proof to show that a supplement is not safe which can lead to the removal of such products from the market,” Grundmann explains.

“Prior to marketing, the FDA has very limited regulatory power to prevent supplements that are of questionable quality to be made available to patients and customers.”

The AACP notes that in 2010, the FDA was granted extra authority to enact import bans on certain dietary supplements and nutraceutical products not marketed before the DSHE’s enactment.

“Although new supplements with novel dietary ingredients are undergoing more rigorous analysis, including safety evaluation, it does not affect products already on the market.”

Importantly, efficacy does not need to be shown before marketing a dietary supplement.

Consequences on quality
As a result of the current rules, implementing GMP guidelines requires only internal consistency in product quality and limited testing for contaminants, ACCP underscores in a position paper published in The Journal of Clinical Pharmacology.

“This results in the sale of many dietary supplements containing heavy metals, adulterants including deliberate addition of prescription medication and synthetic illicit substances, microbial contamination and different herbal/plant species or different doses or strengths than labeled,” ACCP adds.

As the current law stands, “quality is primarily optional,” Grundmann highlights.

“Although several manufacturers and distributors are conducting in-house or third-party quality assurance, this should not remain optional. Rather, GMP and quality control should be a necessary part of approval for a supplement to enter the market.”

A need for better education?
Beyond the misinformation and confusion caused by mislabeling, there is also an absence of adequate information on the safe use of the supplements in regard to drug interactions, dosing and potential adverse effects, the ACCP’s new paper highlights.

This is linked to another recently published position paper by ACCP, which states front-line healthcare profession workers lack critical knowledge in dietary supplement and nutraceutical products.

“Dietary and herbal supplements are consumed by nearly 50% of US adults, either in the form of multivitamins, herbal preparations, or other products that are advertised or sold to benefit general well-being,” Grundmann notes.

“Healthcare professionals have to consider potential effects of such supplements when interacting with patients, in particular the impact they may have on prescription drugs.”Healthcare professionals feel insecure due to misinformation in supplement labeling.

Supplement-drug interactions
In a call to action for comprehensive educational opportunities, the ACCP says it is concerned by the increased uptake of supplements by the general public, while professional education on basic pharmacology of these products has been reduced.

“The scientific literature has provided a number of examples of supplement-drug interactions that are clinically impactful and can affect the outcome of therapeutic interventions. Given the lack of broader regulations in regards to the quality of supplements, adequate knowledge on the limitations of supplement use is essential to healthcare professionals,” Grundmann adds.

“Patients will benefit from this knowledge to be counseled on the safe use of supplements in addition to their prescription drugs.”

Onus on regulators?
Industry experts previously told NutritionInsight that particularly since the COVID-19 pandemic, there has been a spike of scammers and “miracle-cure charlatans” bombarding the public through social media with false or misleading health claims.

On the other hand, consumers have also been deemed more health-aware, particularly in light of immunity concerns linked to COVID-19.

This awareness has also seen the growing trend of premiumization, where consumers are more observant about where raw ingredients are sourced from, the manufacturing process and clinical studies about their products.

By Andria Kades

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