Five questions for the FDA’s new Office of Dietary Supplements, increasing State actions, and key preparations for an election year: NPA’s Fabricant looks ahead to 2016
The Natural Products Association enters its 80th year as the premier organization dedicated solely to the natural products industry in 2016. For the past 80 years, our top priority has been and always will be to enhance, expand and protect our members’ ability to respond to the growing global demand for high quality and safe natural products: be they nutritional supplements, personal care, or home care products. Our industry is growing strongly because people want truly natural alternatives.
Our mission will continue in earnest this year, as NPA will continue to lead the charge on Capitol Hill and in state houses, with federal and state regulators; and in courts, global venues, and the media. NPA’s national and global advocacy has helped grow and protect markets for our products in three fundamental ways:
1) Constant Informational Exchange with Federal and State Regulators:
The experience of NPA’s top leadership is unparalleled, as the President and CEO, Dr. Daniel Fabricant, and the Senior Vice President of Scientific and Regulatory Affairs, Dr. Corey Hilmas, both served as the top officials in the Food and Drug Administration’s Division of Dietary Supplements. Their expertise has proven to be invaluable to NPA members and to regulators as they work together to continue building on a regulatory regime that delivers safety, quality, and access. NPA provides regular official comments to government rulemakings in addition to an ongoing informal dialogue with important stakeholders.
2) Identifying and Addressing Misguided Proposals that Would Limit Consumer Access and Increase Prices for Natural Products:
NPA’s extensive national reach and grassroots network provides a state-of-the-art intelligence gathering system that identifies legislative or regulatory proposals that could deny access to and/or increase prices of natural products. NPA then deploys its vast educational resources, personnel and other assets to address these proposals in a way that protects customers, suppliers, manufacturers, and retailers.
3) Changing the Narrative Through Constant Response to Critics and Media Misperceptions:
NPA is on the front lines of an increasingly intense public debate about the strict regulatory regime that governs our industry. We have aggressively challenged inaccurate claims that the industry is “unregulated” or “under-regulated” in national, state, local, and social media. We have challenged critics to release data and methodologies they claim is the source of their allegations of wrongdoing. We have worked with reporters to help them understand that adulteration of supplements is illegal, and that the government has a responsibility to prosecute criminal activity vigorously. And we will continue to expand and refine those efforts in 2016 as we are sure to face similar challenges this year.
Through these and other channels, NPA is best positioned and equipped to lead our industry at this exciting moment. It is a moment that presents tremendous opportunities due to growing demand and sophisticated challenges from those seeking to disparage the great value our products provide.
New Office of Dietary Supplements at the Food and Drug Administration
One opportunity to note in 2016 will be engaging with the new Office of Dietary Supplements (ODS) at FDA. This is a long overdue step towards elevating the dietary supplement division within FDA so that it can exercise all the authorities it has to regulate this important industry. NPA strongly supported this decision and will continue to work with FDA and other regulatory officials to deliver quality products for the millions of people in the U.S. and around the world. To that end, there are five key areas that we will be discussing with the new ODS in the near future:
1. What plan does ODS have for working with the Department of Justice (DOJ) to pursue swifter cases against bad actors like those who spike products with drugs and call them dietary supplements?
2. When does ODS anticipate NDI guidance to be released as well as clarification as to what an NDI is and is not?
3. As an office within FDA, what is ODS' strategic plan for next 3 years? 5 years? 10 years?
4. When will ODS engage the industry on ingredients covered under FSMA?
5. Will ODS release statistics on regulatory and enforcement actions?
Through this dialogue, NPA will also encourage the new ODS take a stronger stance on enforcing the laws currently on the books, specifically:
• Collaborating with DOJ to take up misdemeanor cases to deter unscrupulous companies which have traditionally flown under FDA's radar because of their small size.
• Working to identify dietary ingredients found to be unsafe and remove them from the marketplace through the use of the 402(f)(1)(B) charge more frequently.
• Using all tools available, including mandatory recall authority, administrative detentions, and the use of seizures, in favor over injunction, as a method to more appropriate curb and deter adulteration and misbranding.
FDA Administrator Nominee Robert Califf
NPA has engaged publicly in the nomination proceedings of Dr. Robert Califf, President Obama’s nominee to be Administrator of the FDA. In a November 2015 letter to the Chairman and Ranking Member of the Senate Health, Education, Labor, and Pensions Committee, NPA shared concerns about previous statements made by Dr. Califf in which he suggested that dietary supplements should be regulated the same way as pharmaceutical products.
While NPA awaits satisfactory replies to these and other concerns, we are continuing to monitor the nomination and confirmation, and would seek to meet with the new Administrator if and when he is confirmed by the U.S. Senate.
Federal Regulatory Actions in Final Year of Sitting Administration
Based on public statements by top Administration officials and NPA’s own discussions with sources both in and outside of government, we are preparing for the possibility of a potential spike in regulatory action that has become a hallmark for Administrations in their last year of authority. While it is difficult to anticipate the exact nature of hypothetical proposals, NPA will be working to avoid surprises to the extent possible and to engage with officials to ensure any proposals reflect consumer and industry priorities.
Congressional Opportunity and Challenges
One of NPA’s top goals to expand access for consumers is through a legislative proposal entitled the Family and Retirement Health Investment Act, which would allow FSA and HSA dollars to be spent on nutritional supplements and other natural products. Since proper nutrition is essential to health and wellness, we are working to convince lawmakers that supplements should be treated like other similar expenditures for the millions of Americans who use these accounts.
NPA will also engage Congress on the Free Speech About Science Act and the Personal Care Product Oversight Act, which requires cosmetics companies to register their facilities with the Food and Drug Administration (FDA) and to submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients.
And on the tax policy side, NPA began 2016 by becoming a member of the Internet Freedom Tax Act (IFTA) Coalition, which seeks to enact a permanent ban on the taxation of internet commerce. With retailers and consumers using e-commerce at record rates, NPA believes it is important to stand up for our members so they can continue to provide products at competitive prices. NPA is the first and only representative of our industry that is working with the coalition.
In addition to these legislative opportunities, NPA is also preparing to address the inevitable misguided, unnecessary, and other proposals which would limit access and raise prices for natural products. As we experienced with the Defense Authorization bill last year, supplement critics Richard Durbin (D-IL) and Richard Blumenthal (D-CT) are likely to use the Innovation for Healthier Americans act as a vehicle to attach a version of their Dietary Supplement Labeling Act if and when it reaches the Floor of the Senate.
We are working with our allies and others to continue to convince lawmakers that this proposal is unnecessary and will only serve to hurt consumers. While we are confident that we will prevail, we are always on the lookout for these kinds of tactics and ready to deploy assets as necessary.
State Attorneys General and State Legislative Proposals
The greatest potential for severe limitations on consumer access and restrictions to free commerce for natural products and supplements, however, is likely to be caused by misguided action by Attorneys General. In 2015, NPA responded immediately to the New York Attorney General’s action by engaging directly with his office and restoring the ability of members to sell their products.
This engagement -- a series of face-to-face meetings and informational exchange -- continues to this day and will extend throughout the year. NPA will employ this same successful approach to explain the complexities of our industry and the regulatory regime to other Attorneys General in an effort to preserve consumer access to supplements.
Likewise, NPA will also be on the lookout for new and pending state legislation that could have an impact on the industry. For example, NPA was quick to address the challenge of a harmful proposal in Massachusetts last year that would have moved fitness supplements behind the counter and denied access to consumers. Thanks to NPA’s grassroots and legislative teams, this proposal was tabled.
Another avenue that we are preparing for is the continued expansion of NPA’s Political Action Committee, the industry’s largest. We are fortunate to have good friends and allies in the Congress, and we need to help them while seizing the opportunity to meet new leaders and properly introduce them to our industry and our issues. NPA PAC enjoyed very strong support in 2015 and already is on pace for a record-breaking 2016.
In summary, we expect 2016 to be one of the industry’s most exciting but challenging years. We look forward to working with our members and others in the industry, and you will see our impact in national media features on our industry, including PBS Frontline on January 19th, and on other cable news channels.
Our voice is getting stronger because our membership is growing, as more companies understand the need for strong and experienced leadership to face these complex challenges. For the past 80 years, the Natural Products Association and its members have been the go-to sources for advocacy, information, training, networking and communications. We look forward to continuing that leadership role in the years ahead.