GNC, FDA Aim Alignment of U.S. with Global Standards

The job of qualifying dietary supplement ingredients done the “old way"—low cost, minimal testing, unexamined supply chain—is getting harder by the day.

The United Natural Products Alliance (UNPA) Raw Materials meeting in Salt Lake City, Feb. 23 to 24, 2016, presented a new example of industry coming together to address gaps in supplement ingredient quality and safety.

At the meeting, GNC CEO Mike Archbold presented GNC’s new mandate, “effective immediately" for the development of botanical ingredient standards aligned with best practices for herbal medicines around the world. “Be the change you want to see" was the resounding message.

GNC’s new draft standard, detailed in a 58-page draft document, combines major elements of the Good Agricultural and Collection Practices (GACP) developed nearly a decade ago by the American Herbal Products Association (AHPA) and American Herbal Pharmacopoeia (AHP), which was not widely adopted by the herbal/botanical industry. GACP requires controls and documentation, many down to the farm level—a standard that is not generally documented to exist for many botanical raw materials.

The GNC standard also requires ingredient manufacturing facilities to take the next leap and meet the same or similar standards required for finished consumer products—a standard that to date is not generally met by foreign ingredient suppliers.

While the new GNC standard remains in draft form for now, it adds another standard to the diverse list of requirements ingredient suppliers are subjected to by their various customers and foreign country requirements. Also recently added to their list was hazard analysis critical control point (HACCP) and foreign supplier verification as required by the new Food Safety Modernization Act (FSMA) rule. However, elements of FSMA were absent from the draft GNC standard, presumably covered by the stricter GMP (good manufacturing practice) requirements.

The GNC standard, when finalized, is expected to be a positive disruption for a supply chain prone to gaps in controls related to quality and safety. To many who have already dedicated years to achieving near-European quality standards for ingredients and products in the U.S. market, a market leader stepping out to achieve these standards is long overdue.

Not everyone involved in the supply chain seems excited. GNC suppliers are likely to be in two camps: those who take the mandate for improvement as an opportunity to show they are already meeting the standard or are willing to invest in it, and the other camp who consider it all unnecessary and too much work.

The challenges are real, as are the incentives to improve. The main takeaways from CFR 117, which many call the most important since the Dietary Supplement Health and Education Act of 1994 (DSHEA) for dietary ingredients, are pretty clear:  1. The onus is now on ingredient suppliers and importers to verify the quality and safety of ingredients they sell; 2. Each product (not facility) requires a HACCP plan, with few exceptions; and 3. Ignoring product safety issues is now a criminal offense, not just a civil one.

More than a few experts have agreed that the gap between the ingredient and finished product regulatory requirements needs to be addressed. As FDA correctly asserts, this need is especially applicable for imported materials produced in parts of the world still struggling with issues affecting product safety, such as water quality.

Precisely how ingredient companies are to bridge the gap and integrate the GNC standards with new FSMA requirements is one yet to be addressed. But it’s also clear that a food safety plan using the basis of hazard analysis can be complementary to GMPs in ways that help develop smarter specifications, quality systems and monitoring plans that are risk-based, robust and practical.

It is also possible that specifications covering potential product safety issues could preclude some HACCP requirements. This is where verifying specifications for their ability to control product safety risks can be a useful way to cover some FMSA requirements with existing GMP standards.

And while a number of overlapping standards are available for supplement ingredients, it appears that no one has developed a single standard that is as powerful as it is effective and usable. By adding in elements of risk-based evaluation—like the SIDI Supplier Qualification protocol does—and combining food safety with GMPs, suppliers can focus on the most important issues affecting product safety and quality.

What does this mean for finished product manufacturers? For many, it means taking more responsibility for ingredient sources and manufacturing practices beyond testing against all items on the specification, a practice which just now is becoming commonplace for most U.S. suppliers and manufacturers. But it also means reviewing specifications for their ability to control for contaminants that affect product safety—not just accepting the specification that the supplier happens to comply with, and testing against it.

Reviewing specifications from a product safety perspective requires that buyers of ingredients should understand ingredient cultivation, harvesting and manufacturing processes to the extent needed to determine whether the specification is sufficient to control for product safety hazards. This also means a deeper dive into supplier documentation beyond the mere presence of a supporting document and toward an understanding of its true meaning: to what extent does this document support the quality and safety of the ingredient?

For many ingredient suppliers, the ability to fulfill the added responsibilities may require more resources, which should come in the form of guidance documents, audit checklists, training and expert verification. Ingredient suppliers who have not themselves audited manufacturing facilities and practices of their suppliers related to product safety require this type of support. Luckily, these resources are expected to be part of a sizable investment that the industry quality movement—now led by GNC—can dedicate ourselves to.

For those who are not prepared to invest in improvement, the voices of the responsible and committed majority of the industry have spoken clearly: If you’re not dedicated to evolving and improving the quality and traceability of your products, then you should pursue another career path that doesn’t involve products people consume to support their health.

But buyer (and idealists) beware: Some key but subtle differences exist between a set of standards that fall quietly in the forest versus those that ultimately enjoy widespread adoption. Only one is the result of collaboration, leadership and self-regulation that extends beyond creation of the standard itself.

How well we can execute on developing a widely used and optimized set of quality standards for ingredients will be a major factor driving industry growth in the years to come. Now is the time to be the change.

Blake Ebersole has led a number of botanical quality initiatives and formed collaborations with dozens of universities and research centers. As president of NaturPro Scientific, Ebersole established quality compliance and product development services for supplements and ingredients such as ID Verified™. Follow him on Twitter at @NaturalBlake.