The Dietary Supplements Health and Education Act (DSHEA) was enacted on October 25, 1994. Thirty years is a symbolic milestone in different ways; it shows sustainability and simultaneously inspires a timely review of how the dietary supplement industry has responded. It prompts a reflective examination of several factors, including its impact on inventory management practices.
DSHEA was the work of Senator Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa). Interestingly, the bill was both opposed and supported by the dietary supplement industry at large. The bill included what defined a supplement, product labeling, and regulatory review. Criticism of DSHEA has also divided since its enactment; some hold that its compliance requirements are too demanding, while others say its coverage does not go far or deep enough.
So, how is the industry doing in relation to compliance? 2023 resulted in 501 total FDA inspections, with 48% receiving 483 warning letters detailing observed violations. The most frequent citations were lack of material specifications and procedures for quality control duties. Some of these violations are the result of unawareness (the ‘we’re CPG’ mindset), while others were simply not willing to cover the effort and costs of doing business in the dietary supplement domain.
Here’s a powerful example from several of the dietary supplement suppliers to Amazon. A university-driven study  revealed issues like mislabeled products, inaccurate listing of ingredients (identity and concentration), and misleading health improvement claims. Because these producers are commercially visible, this impacts the consumer and the regulatory community. In response, Amazon says they are now requiring new quality requirements, hopefully resulting in an equally visible resolution and a strong case for other producers to follow suit.
InstantGMP is also celebrating a milestone anniversary, 20 years, in May of this year. During that time, we’ve been addressing the specific needs of the dietary supplements industry, as illustrated by our repeat and expansion of dietary supplement customers. We continue to provide and improve our data solutions that automate and simplify Electronic Batch Records and Inventory Management. Our user-configurable toolkit will readjust operations with the changes in your business. Our CFR-based manufacturing software design and experienced support personnel can prevent many of these problems and, in addition, improve production efficiency.
Let’s discuss a sound, realistic GMP strategy for your dietary supplements firm inventory management! Contact us today.
“Dietary Supplements Health and Safety Act of 1994”, Wikipedia
John Long, “Top FDA cGMP Citation in FY23 Tied to Product Specifications”, Natural Products Insider, 1/8/24.
1.Lauren Manaker MS, RDN, LD, CLEC, “Don’t Rely on Amazon for Legitimate Supplements, Study Finds” Very Well Health, 8/24/22