Upcoming Issue Highlights

Improving the Supplements Narrative in Washington DC

Washington & Natural Products Industry Washington & Natural Products Industry
AIDP

The Participants Are:

• Mike Greene, Senior Vice President, Government Relations, Council for Responsible Nutrition (CRN), Washington, D.C.

• Mark A. LeDoux, Chairman and CEO, Natural Alternatives International, Carlsbad, CA

• Michael McGuffin, President, American Herbal Products Association (AHPA), Washington, D.C.

• Scott C. Tips, JD, President, National Health Federation (NHF), Monrovia, CA

• James S. Turner, JD, Chairman, Citizens for Health, Washington, D.C.

“You want a friend in Washington? Get a dog.” This is a quote that, while wrongly attributed to Harry S. Truman, may still well resonate with many industry members who have interacted with legislators and regulators in Washington D.C.

This panel of experts—which represents perspectives from the natural products industry in addition to trade and consumer advocacy organizations—attempts to shed light on current challenges to (and questions about) the industry and its products coming from many quadrants, from critics to bad actors to regulatory rollouts to even a new White House administration’s posture on regulatory burdens.

NIE: There is a current executive order that effectively creates both a partial regulatory freeze and a requirement that any new regulation be offset by the elimination of existing ones. Explain why this is good, bad or a non-factor for the natural products industry.

LeDoux: Our industry has sought responsible and relevant regulations for the last 25 years. With the passage of DSHEA (Dietary Supplement Health and Education Act) in 1994, we expected the FDA (U.S. Food and Drug Administration) to create and publish good manufacturing practices (GMPs) for our industry, but that effort took a long time.

[In fact], it took a decade to implement something, which should have been promulgated and adopted far sooner. Regulatory agencies exist through public laws and public funding. and the industry, which supplies the tax revenues, expects appropriate oversight.

Recently, there has been much discussion between the agency and the industry groups about proposed rules and guidance associated with new dietary ingredient filings and protocol, but after repeated attempts to engage in meaningful dialogue, this process seems to have stalled as well.

The new administration has promulgated some principles regarding regulatory reform, which can presumably remove some bureaucratic obstacles to innovation and should actually foster business growth. However, with the concerns for food safety, and the continued emphasis on transparency by consumers and local attorneys general, it is not clear whether the administration order will have much impact, either positively or negatively.

Turner: It’s hard to predict right now if this would be good or bad for the natural products industry or the consumers it serves. What is clear is that the partial regulatory freeze and the “one in, two out” requirement do create a level of uncertainty in regard to the status of the NDI (new dietary ingredient) guidance, for example, any movement on the definition of “natural” and more.

Some observers have said that a slowdown in policy and rulemaking is not necessarily the same thing as a downturn in inspections or enforcement. Some have noted that this may be a chance for the right kind of economic analysis of the NDI guidance and an opportunity for the FDA and industry to take a good, hard economic look at the putative consumer benefits, real or imagined, of the ramifications of guidance documents such as this.

While less overt oversight might equate to more freedom to innovate, the question becomes one of consumer confidence—or lack of confidence—in the supply of natural ingredients, dietary supplements and functional foods.

Time will tell; the proof is, in this case, almost literally in the pudding.

Tips: Regulations are not “cost free.” Regulations impose financial and non-financial burdens upon any industry that increase costs to the consumer, reduce competition, and exclude innovative products from the marketplace.

Almost all, if not all, of the regulations imposed by the Federal government on the dietary supplement industry are completely unnecessary. The free market, with freedom of speech, would allow the industry to self-regulate. The most highly regulated sectors of business, financial and insurance, are the rifest with fraud and bad actors. Think about that. Regulations do not automatically bring with them better business conduct; rather, they actually foster more criminal activity and corruption as the least ethical businesses engage in bribery and cronyism with the regulators.

So, any reduction in regulation—so long as it is coupled with ethical players’ unfettered right to protect themselves through a non-corrupt court system and consumer choice—is a good thing for the dietary-supplement industry.

NIE: In a memorandum to agency heads, the White House noted: “Notify the OMB Director promptly of any regulations that, in your view, should be excluded from the directives […] because those regulations affect critical health, safety, financial, or national security matters, or for some other reason.”

Does this “critical health” or food “safety” exception apply to the natural products industry and to the final rollout of the FSMA (Food Safety Modernization Act) and the NDI Guidance?

LeDoux: The argument that these two areas of regulatory oversight may be exempt from the White House directive is plausible, but industry is unclear as to the sentiments of the agency because there has been a lack of transparency on where the agency is headed.

Recently, several industry participants have informed the agency of a variety of companies selling their products [via] e-commerce that are directly violative of current laws and regulations. The agency has not addressed these, even after acknowledging that these problems clearly exist.

This has to change, particularly when you have a situation where health risks [have been] identified with ingesting products that are illegal per se.

Turner: We don’t know, yet, whether the “otherwise required by law” or public-safety proviso will allow the FDA to avoid the “two for one” requirement in regard to dietary supplements and ingredients.

It is hard to know what to root for, existing guidance, for which the ramifications are unclear, or a stay on this guidance regarding which we are also unclear. It’s not even a case of the devil you know is better than the devil you don’t, because we don’t even know the devil either.

McGuffin: FDA’s implementation of FSMA or finalizing of NDI Guidance do not appear to be impeded by the new administration or this specific executive order.

NIE: Representative Mia Love (R-UT) has taken on a new role as co-chair of the Congressional Dietary Supplement Caucus (DSC), replacing Rep. Jason Chaffetz. In a press release dated August 5, Congresswoman Love said: “I’m excited to begin work on behalf of the 68 percent of Americans who take dietary supplements every year.”

She added: “Not only do dietary supplement companies provide jobs and opportunities here, they give consumers the opportunity to make educated choices to fill critical nutrient gaps and achieve better health.”

Do Rep. Love’s remarks potentially represent one sign of a new era in the recognized mainstreaming and greater legitimizing of dietary supplements in America? If so, how? If not, why?

Greene: CRN is thrilled to be working with Rep. Mia Love of Utah in her new role of Republican co-chair, following the departure of former member of Congress, Jason Chaffetz. Her interest in nutrition and dietary supplements will be an asset to the Dietary Supplement Caucus (DSC) as it moves into its 12th year. I believe her leadership will also be helpful as she works with the other co-chairs, Rep. Jared Polis (D-CO) and Sens. Orrin Hatch (R-UT) and Martin Heinrich (D-NM).

We find that when CRN meets with elected officials in the House of Representatives or in the Senate, many acknowledge their own use of dietary supplements. Health and wellness and good nutrition are mainstream, and the DSC is a reflection of that.

The caucus is bipartisan and bicameral, and the 35 members of Congress, who are current members of the DSC, are representative of all facets of Americans who use and believe in dietary supplements. The DSC remains the best way to share information about dietary supplement regulation, products, and nutrition with legislators and staff.

McGuffin: Rep. Love’s statement and engagement in the caucus are another indication that dietary supplements have been accepted by mainstream America. As more consumers use supplements to improve their quality of life, more representatives in Congress are recognizing the importance of these products.

In addition, AHPA and other supplement industry trade groups are working hard to inform lawmakers about the significant, positive impact this industry has on the U.S. economy.

More and more lawmakers understand the positive impact the industry has on consumer wellbeing and the economy thanks to concerted advocacy efforts by groups representing the industry on Capitol Hill.

LeDoux: Representative Love is from a district that is well populated with companies engaged in manufacturing and distributing dietary supplements, so this is a welcome endorsement of our efforts.

However, more has to be done with oversight of the various agencies and departments that may not share her sentiments.

For example, after attending the recent Codex Alimentarius Commission meetings in Geneva, Switzerland, an opportunity arose to push back on what U.S. industry and academia believe are artificially low NRVs (nutrient reference values) for two essential nutrients, vitamins D and E, and the U.S. delegation did not object to this adoption, even though these numbers are far below equivalents in the U.S. and other developed nations.

When industry members approached U.S. government personnel, they were told that this was not a big issue for the U.S. government. Really? Addressing deficiencies that can lead to serious health risks and attendant costs to the medical care system [are] not of interest to the U.S. government?

Miss Love and her colleagues in Congress would be well advised to ask members of the Codex offices of the U.S. Department of Agriculture and the Food and Drug Administration why they have adopted this illogical position.

Turner: While congressional member organizations (CMOs), such as the Dietary Supplement Caucus, appear to be taking heat of late by critics and plaintiff attorneys who represent the not-so-huddled masses of those who believe that only the lobby around synthetic chemicals and prescription drugs should have its supporters on Capitol Hill, dietary supplementation is part of a consumer self-care movement that features a strong belief in the value of a clean, healthy food supply and diet and healthy skepticism regarding drugs and chemicals.

Rep. Love supports this consumer mandate, and for that she deserves our support.

Tips: Rep. Love’s remarks are very welcome, but until we eliminate the stranglehold that the […] pharmaceutical industry and Big Ag have over our health and nutrition, there is still a long row to hoe.

NIE: More than 170 million Americans take dietary supplements and the industry contributes $122 billion and over 750,000 jobs to the economy.

Supplements definitely have a seat at our dinner table. Is this message getting through in Washington to U.S. legislators and to state legislators, such as in New York state?

What evidence do we have one way or the other that supplements also now have “a seat at the table” in D.C. and in Albany?

McGuffin: These numbers demonstrate that the industry is mainstream among consumers, but some lawmakers and regulators still seem behind on this.

Several myths and misconceptions about supplement safety, efficacy and regulation persist and industry critics frequently exploit these myths, making the supplement industry a target for regulators and negative media coverage.

The supplement industry continues to work diligently to debunk misconceptions by building relationships with lawmakers and regulators to ensure they have accurate information about this well-regulated class of goods.

Greene: The message is getting through, but more work needs to be done. Whether we are sharing information about the 170 million Americans who take dietary supplements annually, the 750,000 good paying U.S. jobs that are created by the dietary supplement industry or the most recent NBJ dietary supplement sales figures at roughly $41 billion, many on Capitol Hill are aware of the size and rapid growth of the dietary supplement industry.

There are still issues that need to be addressed at the federal level, like ensuring low-income Americans have access to a multivitamin mineral dietary supplement through government programs like SNAP (Supplemental Nutrition Assistance Program) or WIC (Women, Infants and Children) or allowing a family to use their tax-free medical savings accounts, like a health savings or flexible spending account (HSAs/FSAs), to purchase dietary supplements.

In addition, key states, like New York and Massachusetts, continue to introduce dietary supplement legislation because they believe the federal oversight system put in place by DSHEA is not appropriate, and therefore we should expect continued activity in activist state capitals like Albany, Trenton, Boston and Sacramento. State and local concerns will continue to grow, so we in government relations must be vigilant. And having a state presence and sharing important facts will be [vital] as we meet with state and local decision makers.

Turner: Hard to see where the federal government has all of its sights set at the moment, especially in light of the very muddy waters now due to the regulatory freeze.

However, at the state level, New York has its fair share of state lawmakers who want all sorts of warnings on supplement labels and who would be more than happy, based on past task forces and efforts, to move the state in the direction of pre-approval of supplements, ingredients and claims while needlessly alarming consumers about those same beneficial products.

And where goeth New York and California, so eventually goeth other states, too.

On balance, supplements might be a little better respected by legislators, attorneys general and regulators than they were in the early 1990s, but the forces arrayed against American consumers in this health battle are no less potent than ever before.

Tips: While true that supplements have a “seat at our dinner table,” that does not mean that anyone is actually talking to us while seated there! We are mostly eating alone.

Certain trade organizations, especially the Council for Responsible Nutrition, have been responsible [in] convincing certain politicians and regulators that dietary supplements are legitimate.

However, the political and regulatory players change often and then the task of convincing new faces must take place.

It’s a never-ending game, albeit one that I think we will ultimately win. After all, dietary supplements do have value and do work.

NIE: In June 2017, the GAO issued a report that drew attention to big problems of some wild claims and irresponsible marketing regarding dietary supplements geared for memory and cognition. Recognizing that we have a rapidly growing pool of aging Baby Boomers who are living longer, what are these extreme cases an example of? Fly-by-night outfits masquerading as legitimate dietary supplement companies selling questionable nostrums, or is this a case where we need to take a good, hard look at ourselves as an industry?

Turner: The natural products industry is at a crossroads. There is a powerful body of evidence supporting responsible use of supplements that support cognitive health. The population of older Americans who could benefit from these food supplements has never been greater. As our needs grow, so do the interests of brain-boosting supplement makers and marketers.

The vast majority of these products and manufacturers are beneficial and legitimate, respectively. However, there will always be a small number of irresponsible purveyors who will prey on vulnerable consumers who are fearful of aging and who are desperate for solutions and support.

We strongly support efforts to marginalize and aggressively pursue enforcement actions against despicable outfits such as these.

McGuffin: This is more of an enforcement issue and the regulated industry vocally supports strong enforcement of current laws and regulations that prohibit the marketing of these products with false or misleading claims. Better enforcement would likely go a long way to clamping down on unscrupulous companies. At the same time, it is worth investigating claims that are allowed for supplements. Many claims that are not misleading and supported by evidence are still prohibited for this class of goods.

Tips: Undoubtedly, there are bad actors in that market segment, just as there are in every other business. The best and most moral way to counter such bad actors is through unfettered free-market mechanisms that allow for the free flow of consumer information and through legal actions brought in non-corrupt courts that will greatly discourage and minimize bad actors.

Remember, no system is perfect and there will always be bad actors in any industry. The goal is not to eliminate them entirely but rather to minimize their presence and ill effects.

That is best accomplished through free-market mechanisms, not through perhaps well-intentioned but heavy-handed and misguided over-regulation.

LeDoux: This is an area where the FTC (Federal Trade Commission) needs to step up oversight. I would hazard a guess that most of these products are not from responsible members of our industry, but rather from opportunists who see a way to make a lot of money in a short time by taking advantage of people in need.

Advertising standards need to be tightened, and frankly, companies selling products with unsubstantiated claims need to be heavily fined and their owners subjected to personal liability.

NIE: What are the biggest supplement industry problems we need to aggressively address right now and how will this help us in Washington?

LeDoux: If one looks at the big picture, the real issues that are in front of the industry are:

a. Protection of intellectual property and enhancing research and protection of patented ingredients.

b. Assessing the real cost-benefit analysis associated with dietary supplementation and reduction of disease states.

c. Assuring adequate and timely enforcement of DSHEA by the FDA Office of Dietary Supplements and the FDA legal staff.

d. Improving fair and free trade through enforcing WTO (World Trade Organization) standards of transparency of regulations. In essence, USTR (U.S. Trade Representative) needs to force open markets that are happy to sell U.S. industry their raw materials, but which make sales of finished products to their markets unduly burdensome.

e. Adoption of a list of pre-DSHEA grandfathered nutrients.

f. Improving seizure enforcement and prosecution of criminals falsely hiding behind our industry with knowingly adulterated goods.” NIE

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