A significant, historic milestone for dietary supplements was in 1994, when the Dietary Supplement Health and Education Act (DSHEA) became law. It can also be argued that in 2020 the category reached a major crossroads as a result of a year of accelerated growth and aggressive product positioning. Against the backdrop of COVID-19 and accelerating consumer interest, DSHEA is facing a real pressure test and broader calls for modernization. Renewed support to protect and strengthen regulation of the category could contribute to a potential sea change to the dietary supplement marketplace, resulting in a new trajectory for industry.
The Impact of COVID-19
The world changed in 2020 due to the global COVID-19 pandemic.
Awareness and interest in the role of preventive health has increased among consumers and stakeholders across the healthcare space, especially for condition specific support of the immune system. In 2020, experts and the public became more familiar with how underlying health conditions pose risks that can lead to devastating health outcomes.
The urgency of COVID-19 has emboldened the healthcare community to empower consumers to educate themselves and understand why taking action to stay healthy matters; specifically to prevent the spread of COVID-19 in their community by wearing a mask and staying home, but also supporting their personal health – as well as their family’s – through positive, everyday lifestyle behaviors.
The Self-Care Trend
Consumers actively care about their health and wellness, as demonstrated by the consumer driven growth in personal healthcare products across categories, including dietary supplements. In fact, dietary supplements play a critical role in supporting the health of more than 70% of Americans, with an estimated 30% of users in an expanded market segment thought to be new to supplementation this year alone.
COVID-19 has only amplified existing trends. For example, consumers have never been more informed or involved in their own healthcare. There is more information available to help them better understand their individual needs and identify the right solution. As the pandemic kept many consumers at home for much of 2020, they’ve been doing more of their shopping and learning from the comfort of their kitchen tables. The self-care trend is certainly being felt in the dietary supplement space – in 2020 we saw the highest category growth since 1997, along with an increase in the number of dietary supplement product launches.
But as consumers take ownership of their healthcare, they should have confidence that the products they take are safe and high quality.
Regulatory Actions
Today, more than 70,000 dietary supplement products are on the market, compared to 4,000 in the mid-1990s. While the barriers to enter this category are manageable for many companies, the ease of entry should not be achieved by circumventing regulatory requirements.
In 2020, FDA issued approximately 200 warning letters and other actions against companies for reasons including unsubstantiated claims, mislabeled products, failure to adhere to cGMP standards, or selected distribution of adulterated raw materials and their use in finished products. While many businesses in the dietary supplement category meet or exceed FDA guidelines, gaps in regulatory compliance pose risks to consumer health and tarnish the reputation of the entire dietary supplement community.
At the Consumer Healthcare Products Association (CHPA), we are aware of, and concerned about, the poor practices that exist in parts of the dietary supplement industry. For example, workarounds of regulatory processes, insufficient clinical science to demonstrate safety and benefit of a product, and misleading claims continue to proliferate. Companies that utilize these practices seek to capitalize on consumer fears of illness and desire for unrealistic benefits, both of which pose meaningful safety concerns.
Although supplements from responsible manufacturers follow the current guidelines, there are a number of market entrants that don’t. The simple fact is that the dietary supplements market has outgrown and outpaced the DSHEA framework and modernization is now an important public health issue.
CHPA’s 2021 Dietary Supplements Agenda
CHPA is committed to helping advance best practices in the development, manufacturing, marketing, and regulation of the dietary supplements industry to improve the business landscape and consumers’ confidence in the important, health-supporting products available today and in the future. Through a series of partnerships and collaborations, CHPA is building consensus on important dietary supplement issues with leading manufacturers, other industry associations, public health stakeholders, and regulatory agencies. In 2021, we are focusing on regulatory modernization, supportive legislative solutions, and category credibility.
- Regulatory Modernization
The time to modernize DSHEA has come –the growth we’ve seen in 2020 only underscores this point. CHPA, in collaboration with other supplement associations, advocates for greater transparency across the category through more effective regulation and enforcement, while also providing opportunities for category innovation.
To meet the needs of this rapidly expanding sector, FDA needs a transparent line of sight into the market and resources to oversee it effectively. This is why CHPA feels it is imperative that DSHEA modernization includes mandatory product listing, FDA authorization of third-party current good manufacturing practices (cGMP) inspectors, and additional FDA resources to better enforce regulations. Additionally, CHPA will advocate for new dietary ingredient (NDI) innovation incentives and encourage a renewed look at the definition of “dietary ingredient.”
Clarification of other regulatory provisions are also important to help ensure that FDA’s enforcement and legal actions are robust and sufficient. We all want a sound process in place. We also want an agency that is adequately resourced and responsive, operating under a framework understood by all; all high-quality manufacturers expect it and consumers deserve it.
Similarly, CHPA supports processes under NDI notifications using a master file system with incentives for innovation and increased investment. Clarifying this issue through both legislative and regulatory modifications will strengthen this process and stop workarounds that circumvent adequate procedures.
CHPA looks forward to working collaboratively with FDA to identify solutions that meet the needs of the agency, continue to support consumer access and use, and ensure that the business community continues to improve and act responsibly.
- Additional Legislative Solutions
In 2021, CHPA will advocate for dietary supplements eligibility under FSA and HSA plans to more effectively integrate dietary supplementation into the growing self-care practices of consumers.
We also support robust legislative and regulatory pathways for new health solutions, including Hemp Oil/Hemp derived-CBD products. We will work to help define the framework that ensures only high-quality product forms, supported with relevant and rigorous safety data and full analytical profiling, can be commercialized.
- Category Credibility
Moving forward, CHPA will work with leading healthcare and public health stakeholders to support the appropriate use of dietary supplements and build on the scientific support available. We seek to advance and expand educational opportunities in the healthcare community to illustrate the need for and use of appropriate supplementation, while also providing consumers with credible and balanced information on selection and use of products.
Conclusion
Today, due to the sweeping influence of DSHEA, dietary supplements are recognized by regulatory agencies, healthcare institutions, and businesses as an important healthcare category. We see 2020 as a critical pivot point for the dietary supplement industry as it becomes increasingly valued by consumers who want to achieve their best health. While regulatory performance and oversight must be improved, the scientific credibility of the sector must continue to be enhanced as well. Through legislative and regulatory updates supported by sound clinical science, the category will continue to grow and build on a transparent and credible foundation.
