Q&A: USP on Dietary Supplement Standards

The U.S. Pharmacopeia (USP) is hosting its "Science & Standards Symposium (S3): Functional Foods and Dietary SupplementsGlobal Opportunities and Challenges" in Boston, Sept. 18 to 20, 2012. The conference will cover a range of topics such as standards gaps, regulations, functional standards, botanical geo-authentication and adulteration. Keynote speakers include Paul Coates, Ph.D., Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH), and Deborah A. Duchon, M.A., a nutritional anthropologist.

INSIDER  talked to USP's Markus Lipp, Ph.D., director of food standards, and Gabriel Giancaspro, Ph.D., director of dietary supplements, about the upcoming symposium, including various factors in creating standards for dietary supplements and related products.

INSIDER: Who should attend this symposium?

Lipp: S3 is primarily a science-driven meeting. Target attendees for this symposium include regulatory, quality assurance/quality control, and purchasing professionals with strong background and interest in the science of standards setting. Many of the topics that will be covered are interdisciplinary, so this meeting will speak to a broader group as well. USP envisions this will be of interest to research and development, formulation, compliance and even marketing professionals, given the fundamental issues and challenges facing the industry with regards to functional ingredients. In general, every stakeholder who has an interest in understanding how ingredients can be identified and their quality maintained as they wind their way through the supply chain may find this symposium valuable. While of interest to people in natural products companies, functional ingredients are of major interest to people in other companies as well, given they are being incorporated into a wide range of food, beverage and dietary supplement products on the marketincluding many traditional products.

INSIDER:  Where are the major gaps in dietary supplement standards?

Giancaspro: The main gap is the under-utilization of public standards. Now that cGMPs are in full effect, every manufacturer must develop written specifications for their incoming raw materials, in-process materials and outgoing finished products. Public standards can play a vital role there, by providing common specifications that would facilitate interactions between manufacturers, different suppliers, and regulators. Despite the availability of quality standards that have gone through the scrutiny of experts and interested parties, the absence of required specifications has proven to be a common problem that GMP inspectors are finding. Standards also are necessary in other areas where it is important to ensure identity, quality and purity of a dietary supplement. For example, to ensure comparability of clinical studies designed to assess the efficacy and safety of a particular dietary supplement, clear definitions of the supplement, its identity, and its related specifications are indispensable. Otherwise, comparing various studies will be much more problematic. 

INSIDER:  What are the major challenges facing standards for functional foods?

Lipp: There are a variety of challengesscientific, regulatory and communications/marketing challenges. From a scientific perspective, many of the functional ingredients being utilized are derived from plants, which results in complex and somewhat variable compositions and makes the development of criteria and analytical procedures suitable and necessary to develop verifiable standards that identify such a product unequivocally subsequently difficult. This can be further complicated when a specific function becomes part of the identity; there is the fundamental issue of whether (and to what degree) the functionality of an ingredient is tied to its identity. There are also gaps in the current science surrounding functional ingredients and health claims, including the fact that the mechanisms of the claimed health benefit are not always well understood; functional properties that occur in-vitro in the laboratory may not translate to an in-vivo effect in the human body; in most cases there is a lack of generally accepted and validated biomarkers to measure the alleged health benefits properly; and others. The regulatory environment governing these ingredients/products is intricate, with various levels of allowable claims in the United States, and regulations differing from country to country. In the meantime, there is often a communications gap in terms of the language is placed on the label of products and how consumers interpret this language and the claimed health benefit. All of this points to the need for standards.

INSIDER:  What is needed for verifying geo-authentic botanicals, and do these materials present different challenges than other botanicals?

Giancaspro: Standards are necessary whenever there is a need to understand and verify claims made on certain ingredients. The provenance of a dietary supplement is sometimes claimed to add perceived value to a botanical. In some cases, traditional medicines from botanical origin are considered of good quality and effective only when coming from a certain region. However, it is often difficult to find analytical procedures that allow the verification from which region or geographical area such an ingredient originates. 

INSIDER:  How much has adulteration challenged the dietary supplement industry and increased the urgency for new or updated standards?

Giancaspro: Adulteration is a major challenge for the dietary supplement industry, from the illegal and undeclared presence of pharmaceutical substances, to poor and insufficient quality, to simply selling the wrong plant speciesthe list is long. The uptick in warning letters from FDA illustrates how seriously the agency is treating this issue, and any adulteration episode negatively impacts the reputation of the entire industryincluding ethical players. Tight quality specifications, particularly for identification, is a focus for USP in addressing this issue. By better defining what something is, as opposed to what it isnt (which would require testing for an endless list of potential adulterants), stakeholders can control much better for adulteration. The USP symposium will address various techniques for identity testing for dietary supplements, including classical pharmacognosy coupled with instrumental analysis (e.g., UV, HPLC), nuclear magnetic resonance, and DNA methods for articles of botanical origin. Some of these are already utilized in USPs standards, and others are being explored, such as DNA methods.

INSIDER:  How much of a role does technological innovation/advancement (techniques, equipment, etc.) play?

Lipp: Keeping pace with technological innovations is often a key driver for updating standards for two major reasons. New technologies offer new opportunities for a better verification of the identity and purity of dietary supplements and food ingredients. Old technology can become obsolete and in order to keep USPs standard relevant, they are updated to reflect the changes in technology. USP continually and critically evaluates all new technologies and strives for finding the optimal balance between a stringent standard, costs and availability of the analytical techniques employed.

INSIDER:  What do you hope the symposium achieves?

Lipp: We are hoping to bring together a diverse group of experts from various disciplines in the food and dietary supplement industries, regulatory agencies and other stakeholders to explore the multifaceted challenges associated with these new and interesting ingredientsand help determine how USP can develop meaningful standards that will assist ingredient suppliers and manufacturers formulating with these products, regulators responsible for overseeing them and other stakeholders. More information on the symposium is available at http://uspgo.to/boston-s3-2012.