FDLI Supplement Regs Conference: Day One

WASHINGTON—Within Eyesight of the U.S. Capitol building, attendees at the Food and Drug Law Institute (FDLI) conference on "What you Need to Know Now about Emerging Dietary Supplements Issues & Trends" caught up on the regulations affecting dietary supplements in addition to catching a glimpse of the future regulatory environment in the category. Speakers at the conference included experts from both government and industry, including industry-related attorneys.

A big area of concern and activity on supplement regulation is in the area of health claims and structure-function claims. Claudia Lewis-Eng, partner at Venable LLC, reviewed what are permissible vs. impermissible structure-function claims, including FDA's eleven criteria. She spent considerable time covering the substantiation that is required for such claims, noting clinical trials on humans are the standard.

Kathleen Elwood, Ph.D., director of nutrition programs in the Office of Nutrition, Labeling and Dietary Supplements at FDA, gave a detailed overview of the regulatory landscape for health claims, including the chronology of laws covering claims, as well as specifics on filing and meeting significant scientific agreement (SSA) requirements. She noted FDA released its "Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims" on Jan. 16 this year, adding this final guidance is very similar tot eh interim final rule previously published.

Claims were a major factor in government actions against dietary supplements in recent years. Karen Weaver, J.D., a partner with Baker & Hostetler, reviewed several prominent cases, including state and federal actions such as warning letters, seizures, fines, imprisonment and ongoing investigations. Warning letters focused on adulterated and misbranded products, drug and disease claims, and combination drug-supplement products. A disturbing trend was the use of metadata and metatags as evidence against supplement companies.

While Weaver noted government agencies, especially FDA, will remain underfunded for it enforcement actions, there are many aspects of the new administration and Congress that could have a profound influence on the dietary supplement industry. Malcom Spicer, managing editor of The Tan Sheet, gave a tour of the new leaders in the Democrat-controlled Congress, detailing some of the actions key members could take, focusing on industry-opponents Sen. Richard Durbin (D-Ill.), Rep. Henry Waxman (D-Calif.), Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.). As for the new Obama Administration, a new FDA Commissioner has not been named, but Spicer reviewed what talk on the hill dubs as the most likely candidates, including Joshua Sharfstein, who is reportedly a stickler for proven efficacy. Spicer added there is speculation two commissioners could be named, one in charge of the food side and the other for the drug side.

One sure trend is increased action against advertising violations by dietary supplement companies, according to Christine Lee, staff attorney in the Division of Advertising Practices at FTC. She reported the agency has spent a great deal of time on cold and flu products, including so-called "immune boosters." Lee detailed several high-profile supplement cases, in which FTC successfully won judgments, including fines, redress, bans and even imprisonment. She reported on FTC's cancer sweep, a joint effort with Canada to weed out cancer cure claims that has resulted in many warning letters and several settlements. She further discussed some new guidance on endorsements,
highlighting the change in typicality, which has removed safe harbor for the use of "Results not typical" in testimonials. Also, endorsers—including celebrities—must disclose any financial ties to the advertiser, a requirement that Lee said extends to advertising on blogs and discussion boards. While the bulk of FTC's actions against supplement advertising were directed towards marketers and manufacturers, Lee warned suppliers' ads in trade or B2B publications have no special protection against FTC action.

Anthony Young, partner with Kleinffeld, Kaplan & Becker, dissected some of these FTC actions for information that could help industry adapt and make changes. He explored why some companies faced FTC's full wrath while others were essentially let go, citing time on the market and swiftness of reaction and correction to FTC's initial warning letters as keys to leniency. However, Young questioned several trends in FTC activity, including its focus on immune boosters and lack of transparency of its process of action against claims violators, such as what constitutes a red flag and more details on substantiation inadequacies.

Looking more closely at the science of substantiation, David Fabricant, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association (NPA), reviewed recent guidance published regarding substantiation for various types of claims, and turned the microscope on why FDA's preferred trial method—randomized, clinical trials (RCTs)—might not be the best for dietary investigations. He also discussed FDA's ongoing efforts in conjunction with the Institute of Medicine (IOM) to qualify biomarkers for surrogate endpoints in chronic disease risk, as a preface to a outline of old vs. new thinking on trial design, including a new focus on adaptive trial designs that consider weight of evidence and employ Baynesian statistical analysis.

Similarly, the science required to support new dietary ingredient (NDI) notifications was reviewed by George Burdock, Ph.D., president of the toxicology firm Burdock Group. Among the highlights were extensive info on chemical identification requirements, and how to establish "reasonable expectation of safety" (RES). He provided several suggestions for successful NDI filing, such as a clear rationale behind why the ingredient is an NDI and why it is not intended to address disease, as well as what constitutes sufficient supporting documents for RES vs. what doe not.

In addition to challenges in adhering to the NDI notification rule, the industry faces a major task in complying with the new good manufacturing practices (GMPs) law. James Cuhady, COO of Sabinsa Corp., outlined the preparations a company must undertake to be ready for GMP compliance and FDA inspection/audit. He stressed understanding the law, creating a team to tackle preparations and conducting gap analyses and process audits. He stressed, "GMP compliance is not just a Quality Control department, but a problem for all departments."

In his folksy manner, Carl Reynolds, vice president of EAS Consulting Group, explained exactly what companies can expect from an FDA inspection and what they should do to be ready. Warning the agency rarely gives prior notification of an inspection, especially in the food industry, Reynolds urged companies to be prepared. He said GMPs is mostly a paperwork program, so it is important to document every process and have those records available for FDA inspection. He suggested internal mock inspection or even a third-party audit could help in this preparation.

GMP compliance and third-party certification programs from NPA, NSF International and U.S. Pharmacopeia (USP) are just part of the range of self-regulation efforts by the industry, according to a summary by Jon Benninger, vice president of business development at Virgo Publishing. Several programs addressed claims in either advertising or labeling, including NPA's trailblazing TruLabel program, the Natural Product Foundation's Truth in Advertising program and a joint initiative by the Council for Responsible Nutrition (CRN), the Electronic Retailers Association (ERA) self-regulatory ad program, and the Better Business Bureau's National Advertising Divison (NAD). Overall, the trade association including NPA, CRN and the American Herbal Products Association (AHPA) hold members to strict codes of ethics and offer many workshops and guidance on critical quality and regulatory issues. Likewise, the newly formed Global Organization for EPA and DHA Omega-3 (GOED) and International Probiotics Association (IPA) are creating standards and quality programs for their specific industry segments. Benninger also covered self-regulatory contributions from Consumerlab.com testing, AOAC methods validation and trade publication and trade show standards programs.

Patricia Knight, president of Knight Capitol Associates and former chief of staff to Sen. Orrin Hatch, said she was pleased to learn all that industry is doing to self-regulate, noting all these activities will help industry make itself more responsible. As an essential component of the Hatch-related partnerships in Congress that resulted in key industry regulations such as DSHEA, AERs and GMPs, Knight provided an insider's view from Capitol Hill on the issues that face the dietary supplement industry. She said FDA will continue to be underfunded, especially as long as its dollars are tied to the agriculture appropriations bill and not Health and Human Services appropriations. She also noted particular areas of improvement for the industry include import issues (i.e. China) and disparity between product content claims and what's truly in the bottle.