The 2nd Annual Legal, Regulatory and Compliance Forum sponsored by the American Conference Institute (ACI) was held in New York City, NY, from June 17th to June 19th 2014. Highlighted topics included the Food and Drug Administration’s (FDA) current attention to New Dietary Ingredient Notifications (NDIN) and the potential for product registration, expectations regarding the Foreign Supplier Verification Program (FSVP) of the Food Safety Modernization Act (FSMA), and the current status of the international dietary supplement market. Featured speakers included Gary L Yingling, Morgan & Bockius LLP, John Venardos, Herbalife International, Scott Bass, Sidley Austin LLP, and Daniel Fabricant, Ph.D., of the Natural Products Association (recently with FDA). The workshops and two-day forum provided insight into the current legal and regulatory environment of dietary supplements, both domestically and internationally. Upcoming changes for the industry were also speculated upon.
NDI Notifications for Dietary Supplements in the United States
A major emphasis of regulatory enforcement in the United States currently focuses on the filing of NDINs for applicable ingredient uses in dietary supplements. Even in the absence of any safety concern, a company is likely to receive a Warning Letter from FDA if an un-notified NDI is contained in a marketed product. A primary reason for the emphasis on proper NDI filing as opposed to safety assessment is the minimal time and cost involved in addressing lapses in paperwork compared to the resources required in demonstrating a product or ingredient is unsafe. A second current issue in the U.S. dietary supplement market concerns the transitioning of an ingredient from use in food to use in a dietary supplement; due to the change in level of use (usually increased) as a food ingredient transitions to new use in a dietary supplement, additional safety studies to support the increased use may be necessary. If the ingredient is an NDI and additional safety studies are required, an NDIN will also be required – even if there is documented use in the food supply.[1] Whether or not such a change requires an NDIN, if use in the food supply is documented and no additional safety studies are needed, awaits clarification from FDA. The “grandfathering” of old dietary ingredients (ODI) was also discussed during the forum, to the effect that although FDA does not officially accept any trade group list, the agency rarely takes action against this argument for an ODI.
There were also instances of forward-looking speculation during the sessions concerning NDIN filing requirements in the U.S. A few parties favored what amounts to an “end-product registration” of finished (retail form) dietary supplement products[2] – the view expressed by at least one speaker was that such a registration would be equivalent to a “birth certificate.” While other speakers and attendees did not go as far as promoting “end-product registration,” NDIN filings were frequently promoted as being originally intended on an “end-product” basis, rather than a “by-ingredient” (i.e., “NDI” ingredient) basis. The largest number of attendees, however, expressed the position that NDIN filings were originally intended only for NDIs, not for every finished product. The recommendation was also made by this latter group that manufacturers of final products should look first to the ingredient manufacturer for any needed NDIN filings before taking this regulatory obligation on themselves.
FSMA & FSVP and the Effect on Dietary Supplement Importers
On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP), importers would be required to perform certain risk-based activities, including:
Compliance status review
Hazard analysis
Verification activities
Corrective actions
Periodic reassessment
Importer identification[3]
Record keeping
The new FSVP activities are required for all importers, in order to verify that food imported into the U.S. has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act.[4] Even though FSVP is not required to be finalized until October 31st of 2014, FDA has announced that dietary ingredients and supplements will not be exempt from these new, complex and detailed regulations. It was generally observed during the forum that “no one would want to be an importer.” That is, the density of these regulations is anticipated to hinder dietary supplement imports to the U.S. due to the length of time and cost of following and documenting the above-listed activities.
Dietary Ingredient Regulations in International Markets
Entry into international markets is not getting any easier for dietary supplements. There is no harmonization in regulations, formulations (including ingredients such as permitted v. not permitted excipients and/or processing aids), labeling, etc. Further, there is no sign that harmonization is on the horizon. In fact, regulations for dietary supplements are moving targets; in at least 40-45 countries, regulations are under current revision in each of the following areas: maximum vitamin and mineral levels, claims, botanicals, and bioactives other than botanicals. In comparison, regulations governing Good Manufacturing Practice (GMP) are more stable; changes to GMP legislation are currently being made in fewer than 15 countries. Due to irreconcilable differences in regulations that govern dietary supplements (including formulation differences such as permitted or not permitted dietary ingredients, excipients, and processing aids), some U.S. companies with domestic and international products manufacture multiple variations of single products, with not all products available in all countries (e.g. Herbalife International Ltd.’s meal replacement products). Other companies, mainly those with markets in only one or two countries outside the U.S., have found it more effective to set up separate facilities or divisions of their company: one in the U.S. for the manufacture of U.S. products and one in the other country to manufacture products for that other country (e.g. Vitamin Shoppe, U.S. and Vitapath, Canada).
International ventures have the greatest chance of success when a consultant with expertise in that country is brought in as an intermediary. In some countries, it is also advisable that the consultant physically reside in the targeted country. A few examples of the variety of regulations one can encounter follow:
Mexico | Positive trade requirement.[5] Only nutritional claims are allowed; no functional claims are permitted.
Argentina | Positive trade requirement, in addition to exacting regulations and limits. Argentina is extremely difficult to enter.
Brazil | Although regulations are being revised to ease the time needed to gain approval for dietary products to less than one year, not all ports are equally easy to enter even for approved dietary supplement products/ingredients. Port shopping has been recommended for approved finished products and ingredients attempting to enter the country.
European Union | Attempts to harmonize dietary supplement regulations among the 28 states is ongoing. Approval of botanic ingredients is still by state (currently about three years wait time, although there are current efforts to reduce the time to about two years).
Greece, Austria, and Russia | Dietary supplements are available only in pharmacies. Although a prescription is not at this point required for the purchase of these products, the sale of dietary products is limited to pharmacies. Such products may not be sold in grocery-type stores or general retail-type stores.
Hong Kong | The physical form of the finished product matters. Dietary supplements in the physical form of tablets or capsules are considered to be drugs.
China | Animal testing is required to support safety. Because a maximum of two claims per product are allowed, shelves of the same product with different labels and label claims are common.
International regulations for dietary supplements are diverse and unlikely to become harmonized in the near future; therefore, understanding a target country’s unique take on regulations is vital for international companies to successfully bring a product to market.
Conclusion
While the international waters of dietary supplement regulation are often in flux, they are certainly not more so than US domestic regulations. With the new FDA regulations for supplement imports provided by FSVP, the future looks extremely uncertain for new dietary supplement products looking to enter the U.S. market. More than ever, companies need to be vigilant about regulatory procedures, both domestically and internationally, in order escape future compliance issues and potential lost revenue.
This article is written for the purposes of reviewing the facts, ideas, and opinions of the speakers and workshop leaders at theAmerican Conference Institute’s 2nd Annual Legal, Regulatory and Compliance Forum on Dietary Supplements and Nutritionals.The views and opinions expressed in this article do not necessarily reflect those of Burdock Group or its affiliates.
[1] Documented use in food for periods of several months (>2 months) to several years were mentioned. The overwhelming point seemed, however, to be documented use, including sales to consumers.
[2] As indicated during the session, registration would be in addition to an NDIN filed on the finished product.
[3] A required data universal numbering system, DUNS, for importers and imported products. See http://www.fda.gov/food/guidanceregulation/fsma/ucm361902 for more information.
[4] Food and Drug Administration. FSMA Proposed Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals”; <http://www.fda.gov/food/guidanceregulation/fsma/ucm361902>; site accessed July 14, 2014.
[5] Essentially, a firm that would like to gain approval for the sale or manufacture of a dietary supplement product in a “positive trade” country is required to export more than it imports. This requirement could be met by the purchase and/or use of local materials and/or personnel, or in extreme cases, by the purchase, export and sale of unrelated items. Positive trade countries may seize ingredients/products from importing countries that fail to meet their trade obligations.