The group behind the effort is known as The Dietary Supplement Quality Collaborative and includes a broad array of interested parties as participants, including trade organizations, a group focused on obesity, and anti-aging group and nonprofits such as the Pew Charitable Trust. The effort is being managed through the Washington DC office of Faegre Baker Daniels Consulting. The plan is to get broad agreement about what a quality dietary supplement ought to look like, and what kind of quality control practices ought to be followed to make sure such products appear consistently in the marketplace. These parameters are expressed as a matrix that is now being submitted to stakeholders for comment.
Consensus statement on quality
According to the group’s mission statement, “The purpose of the Quality Matrix is to identify the elements that the Collaborative believes are necessary to deliver a quality dietary supplement product to the consumer. The Quality Matrix is not intended to establish a regulatory or legislative agenda, but, rather it is a consensus statement of what the Collaborative believes is required to assure quality in the dietary supplement marketplace.”
Larisa Pavlick, vice president of regulatory affairs for the United Natural Products Alliance, had recently distributed the matrix to that group’s members for comment. The window was short, and the organizers of the effort wanted comments back by this week, with another meeting of the group scheduled for July 5. Pavlick was hired by UNPA, which is a participant in the Collaborative, late last year and she emphasized that the outlines of the matrix were already in place by the time she came on board. She also emphasized that the matrix is an aspirational document, rather than a set of obligatory practices.
“This will evolve into the ’20/20 Initiative’, in other words, where do we want to be as an industry in the year 2020?” she said. Pavlick said two additional groups in addition to the quality group are part of the collective. One focuses on adulteration, which the other will concern itself with outreach once the final outlines of the other two prongs are in place.
The matrix is divided into three parts, one of which applies to ingredient sourcing and the supply chain, another to manufacturing and a third to distribution. The recommended practices are drawn in large part from existing GMP requirements. For example, the matrix mentions the need to have test methods that are scientifically valid and fit for purpose, and calls for having standards in place to verify the identity, strength, purity and composition of ingredients.
Going beyond the letter of the law
But the requirements also build upon and go beyond what is called for in the GMP regs. Notably, the matrix calls on ingredient suppliers to apply GMP standards such as those above just as manufacturers are now required to do. Up to now, this has been the manufacturer’s exclusive responsibility, though many higher end distributors of raw materials claim to have many of these practices in place already as a matter of risk management and competitive advantage.
Other aspects of the matrix incorporate quality initiative developed in other parts of the industry that have not been drawn together as a whole before. For example, the raw material section calls on ingredient suppliers to adhere to the Good Agricultural Collection Practices that have been developed by the American Herbal Products Association. Those practices were in turn incorporated in the ‘Botanical GMPs’ document put out by GNC in response to the pressures that arose from the New York Attorney General affair. The final revision of that document is being managed by AHPA. Another recommendation is for marketers of finished products to participate in entering their information into the Supplement OWL database.
Another notable add on to what is called for by federal regulations concerns the widespread use of seals, which has been a hot button topic for UNPA president Loren Israelsen. He has given a talk on a number of occasions that includes two or three Powerpoint slides that are full of all the different seals that can be found on dietary supplement labels, most of which mean nothing and merely serve to cloud the issue. The Collaborative is recommending that seals only be used that come from recognized third parties and for which the process of qualifying for the seal is open and transparent.
When is too much too much?
Pavlick said there is a balancing act in coming up with such foundational documents. As a former FDA inspector, she’s used to working with complicated instruction documents that lay out procedures in detail. It would be ideal from her perspective if someone not very familiar with the industry could use the matrix to determine the quality of a dietary supplement by ticking off the relevant boxes. But referring to outside resources, such as AHPA’s collection standards, or the question of who could be considered a ‘recognized third party,’ complicates that goal and starts to assume increasing amounts of prior knowledge. There’s no perfect answer, she admitted, and also said the parameters of and language of the matrix have been under development for some time, so many of these questions have already been considered at length.
“If you didn’t have any background or experience in this arena this might be too general. The matrix itself is very short. But if you put in too much information, it could make is just as muddy,” she said.