Is the U.S. DSHEA model, which does not include premarket registration, as effective-or even more so-for supplement consumers?
By James C. Griffiths, PhD, Council for Responsible Nutrition
"Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for. A product is not quality because it is hard to make and costs a lot of money, as manufacturers typically believe. This is incompetence. Customers pay only for what is of use to them and gives them value. Nothing else constitutes quality.“ 1
This quote by Peter Drucker is relevant and true, irrespective of the product or market. But what role does regulation play in producing quality products?
Currently, global regulations allowing or restricting market access to dietary supplements are inconsistent, partially due to differences in market maturity, manufacturer savvy, customer expectations, and inherent regulatory philosophy. An ever-expanding global economy with country-to-country raw-material channels and finished-product trade would benefit from true regulatory harmonization-as long as the most restrictive are not deemed the definitive common denominator.
The U.S. Model
In the United States, the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994, but it is only in more recent years that FDA has begun to use the tools at its disposal, starting with enforcement of stringent current Good Manufacturing Practices (cGMPs) in the manufacture of products and supplemented by detailed adverse-event reporting (AER) requirements. These regulatory components, not found in many other countries, take consumer accountability seriously and rely on the expectation of a loyal and long-term seller-buyer relationship. Those dietary supplement manufacturers in the business for the long run respectfully engage with various national regulatory agencies to meet applicable regulations and to provide products that the population seeks.
These two actions-careful attention to cGMPs during manufacture and vigilance in monitoring AER signals when on the market-help ensure the quality of the product at launch and through the market life span.
But the regulators that are empowered to monitor and take action against any deviations from either cGMP or AER regulations must be swift and sufficiently severe to remove irresponsible players and/or coerce improved behavior.
Regulatory Paradigms Elsewhere
Different countries/regions regulate what we term “dietary supplements” differently, but that isn’t necessarily better. Outside the United States, these products may be termed “natural health products,” “food supplements,” “foods for special dietary uses/specified health uses,” etc., and often the regulatory expectations may more closely parallel pharmaceutical regulations than in the U.S. where dietary supplements are regulated as a category of food. Many jurisdictions rely on a premarket approval process-sometimes referred to as a registration-before allowing a product or new ingredient within a product on the market. These premarket dossiers are detailed, expensive, and result in lengthy regulatory review and approval, often interfering with providing consumer access in a reasonable timeframe.
For example, in Australia, the Therapeutic Goods Authority (TGA) authorizes ingredients and claims, as does the European Food Safety Authority (EFSA). In some cases, the allowable claims are quite restrictive to a relatively small set of verbatim statements and then only permitted after extensive human clinical studies that take years and cost millions. EFSA develops positive lists containing well-characterized ingredients and negative lists with forbidden or tightly circumscribed ingredients, but this approach tends to significantly diminish entrepreneurial innovation. Unfortunately, some countries sideline “botanicals” as being too complex and thorny an issue to delve into within current nutrient regulations, resulting in stagnation for this interesting category.
In fact, most non-U.S. paradigms rely on the case-by-case evaluation of the safety and quality of the ingredient or product prior to market launch, rather than relying on stringent cGMPs; however, there’s no indication this method results in additional consumer safety. The countries relying on these premarket restrictions generally have in place weak or nonexistent prescribed cGMP provisions and weak or nonexistent prescribed AER provisions.
Following the DSHEA Model
A DSHEA-like model that utilizes cGMPs and serious adverse-event reporting, coupled with aggressive and prompt regulatory action against non-compliance and/or willful criminal activity, can serve the same level of safety, with greater availability of quality products, than the narrow bottleneck prescribed by a ponderous premarket registration process.
Jim Griffiths is the vice president of scientific and international affairs for the Council for Responsible Nutrition (CRN; Washington, DC), the leading trade association for the dietary supplement and functional food industry.
1. Peter F. Drucker quote (American Educator and Writer, b.1909)