Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond
2015 is certainly ending with a bang. As many of us industry insiders have known for some time, FDA has been planning changes to their regulation and enforcement of dietary supplements. On 21 December 2015, the US Food and Drug Administration announced their new Office of Dietary Supplements Programs (with another new acronym: ODSP). This news is a significant change in how the FDA will regulate and support the still-young dietary supplement industry. From my perspective as both a consumer and long-time industry insider, this announcement is great news. It evidences that dietary supplements have come of age, both for the consuming public, and for FDA, and will ensure a more robust regulatory and enforcement framework, with benefits for most stakeholders. As the announcement stated, the creation “elevat[es] the program from its previous status” indicating FDA is making an implicit (if not explicit) statement that this program area needs specific resources, specialized management, and significant funding.
My experience with dietary supplements and dietary ingredients goes back a long way – to a few years after the effective date of DSHEA, The Dietary Supplement Health and Education Act of 1994. In the late 1990s while at BASF Corporation, I was responsible for the development of the US market entry regulatory strategy for SAMe (S-Adenosylmethionine), and was heavily involved with dietary ingredient regulatory and claims analysis for a variety of BASF’s candidate dietary ingredients. (Click here for a free flowchart to help assess new dietary ingredients under DSHEA.) Also at that time I built a quality system for multiple regulated product classes that also included dietary supplements. Recently, Compliance Architects® has been involved with a significant remediation at a major dietary supplement manufacturer.
These experiences, along with discussions with industry leaders and FDA staff, reflect a changing, dynamic industry. While many companies are embracing FDA’s leadership in establishing dietary supplement GMPs (21 CFR 111 – get a free ebook copy of Part 111 here), along with acting as leaders regarding reputable claims, marketing and advertising, there is still an element within the industry segment that is giving the rest of the industry a bad name, and hurting the reputable companies. These companies have a lot to fear from the new ODSP, as this Office’s new prominence will almost assuredly seek to quickly assert its firm enforcement grip on the dietary supplement industry as a whole, but especially focused on bad actors within the industry. In this regard, FDA has, and will continue to focus on the following areas:
- Identifying and seizing unapproved, illegal ingredients used within dietary supplements, and vigorously prosecuting actions against companies that use such ingredients within their products;
- Ensuring manufacturers have adequate controls for suppliers and contract manufacturers;
- Ensuring dietary supplement manufacturers adhere to 21 CFR 111 and enforcement expectations surrounding dietary supplement GMPs; and
- Ensuring dietary supplement manufacturers and marketers use reasonable, scientifically supported claims that stay on the right side of the structure-function/drug line.
The dietary supplement industry is an exciting and necessary industry for the American consumer. And when companies follow the requirements of DSHEA and FDA’s regulatory and GMP regulations, these products can be both efficacious and safe. However, when companies disregard these requirements – or perhaps even worse – fail to give them the import they deserve – these companies put both the American consumer, and their own businesses at risk.
The new Office of Dietary Supplement Programs (ODSP) heralds a new beginning for an industry that is growing up. It is a great opportunity for all dietary supplement companies to do the right thing, and build the systems and practices that support innovative, helpful products for the American consumer.
For help with 21 CFR Part 111, or for help with commercializing a new dietary ingredient, dietary supplement, or with structure/function claims issues, please contact us.