Dietary Supplement Industry Issues in 2015

Key issues facing the natural products industry in 2015, according to Nutritional Outlook’s editorial advisory board.

George A. Burdock, PhD
Founder
Burdock Group

Contingent upon the relationship between the new Congress and the Executive Branch, and the subsequent actions taken by FDA and other federal agencies (e.g., the FTC), the year 2015 could potentially be a landmark in regulatory change. The degree of hubris exhibited by the agencies in the coming year will be directly proportional to how much the agencies feel the White House has their back; however, Congress still has the power of the purse, which it can use to punish or reward the agencies through budgetary allocations. For example, do not expect the Food Safety Modernization Act (FSMA) to get beyond the farmer’s front gate, and do not expect as robust an Environmental Protection Agency (EPA) in the coming years. Continued aggressive actions by FDA and the EPA in 2014 and 2015 could result in a backlash response with severe cutbacks in funding for these agencies.

Putting FSMA aside as a subject for another time, the principal actions affecting food and supplement companies in 2015 will be: 1) new Generally Recognized as Safe (GRAS) notification guidelines for both human and animal food, to be published in August, 2) new guidelines for New Dietary Ingredient (NDI) notification submissions, which have been promised and may also define the relationship between NDI notifications and GRAS determinations, 3) possible lawsuits regarding FDA’s new guidelines for medical foods, 4) new testing guidelines-i.e., an update of the FDA’s “Redbook”-with a new emphasis on computational toxicology, and 5) new guidelines for randomized controlled trials (RCTs) used in support of health claims.

Lauren Clardy, BSc
Founder/President
NutriMarketing

The international market will continue to expand, and it will become more essential for companies to have a global strategy. Industry organizations are working diligently towards unified standards that will make commercialization and the launch process easier.

We will see continued growth and innovation in new delivery technologies for both solid-dose applications and the food/beverage market. We will continue seeing the convergence of functional foods and dietary supplements on shelves in 2015. Cognitive health and stress management will continue to accelerate as health priorities and will continue to trend in terms of product demand, and we will see some new, innovative plant protein sources.

Dallas Clouatre, PhD
Cofounder, Glykon Technologies
Consultant, Jarrow Formulas

The coming year will continue to reflect the effects of the aging of the Baby Boomer generation-­with one or two important twists. The current economic recovery has not been either robust or deep, and as a result many individuals who under previous circumstances would have expected to retire instead are remaining in the workforce in some capacity. This puts more pressure on demands to remain physically and mentally active. One consequence is an emphasis on preventing sarcopenia, the decline in lean muscle and related physical components of health. Increased protein consumption is a likely response to this challenge in that elevating the fraction of the diet devoted to protein has been shown to be a practical approach to slowing physical decline. Observers in the past have noticed that products originally developed for athletics are often repurposed towards dieting and weight-loss needs; this crossover trend should be expected to continue as consumers harness sports products to help slow the physical decline that accompanies aging. In a related vein, products that target cognition and memory should continue to do well in the natural products market.

Because California is such a large market, pending revisions in the implementation of Proposition 65 could have an impact on the industry depending on their extent and the rapidity with which they are put into force. Many of the provisions of Prop 65 have been used in ways not originally expected, with unintended negative consequences on nutritional product development and sales. Rationalization and harmonization of outlier demands of Prop 65 with FDA and other standards could yield major changes not just in California, but also for companies across the nation that sell into the California market.

John R. Endres, ND
Chief Science Officer
AIBMR Life Sciences Inc.

The FTC seems to be stepping up its enforcement of label claim substantiation, especially for weight-loss and then immunity claims, followed by cancer claims. Companies need to understand what competent and reliable research is needed to support what the FTC considers truthful and not misleading claims.

I believe enforcement will continue to increase and cost companies a lot of resources. Often, published clinical trials that could support FDA-compliant claims are available in the public domain. It is important to understand how to critically evaluate these published studies to make sure they are well-designed and well-executed, and that statistical significance was achieved. It is also very important to look at the totality of the evidence to support claims. In other words, the FTC would certainly frown on referencing a couple of studies that meet such criteria when a number of other studies refute the results (i.e., this would not satisfy the “truthful and not misleading” requirement).

Dan Fabricant, PhD
CEO
Natural Products Association

When looking ahead to 2015, the first thing we must set our sights on is the new Congress. Now is not the time to fall victim to apathy. Many mistakenly believe that we can rest on our laurels because this Congress is pro-business. That sort of thinking will get us into trouble, especially as many in our nation’s capital are predicting Congress to turn again in 2016. Speaking of 2016, the presidential cycle will start earlier than ever, which means Congress’s window of opportunity to actually effect change will be quite short this time around.

Now is the time to be engaged and active in politics, to take matters into our own hands and ensure our issues are being heard.

Industry stakeholders should also keep an eye on legislation by fiat, which in Latin means “it shall be done” and is generally recognized as an authoritative order of law. As we approach the end of one administration, just as a brand new Congress moves into session you will see agency regulators appointed by the White House given the opportunity to write detailed regulations to determine how to interpret and enforce the “will” of Congress and who may not have a full understanding of legislation that has passed. Very rarely does Congress give agencies clarification or direction for implementation of mandates. Additionally, when Congress provides agencies with the authority to write regulations, these regulations do not always clearly determine intent, but rather are designed to enact the agenda of the administration, especially if the administration hasn’t successfully moved its agenda through Congress.

We must also turn our attention to the regulatory agencies. With FDA attempting to include dietary supplements in the “Redbook” expansion, and the FTC overstepping its reach requiring two double-blind, RCT studies, we must continue to watch the federal agencies and speak up and out on issues affecting our industry.

Finally, GMO labeling, especially at the state level, and defining natural, will be hotter topics than ever before. These issues will require industry and consumer engagement at a higher level than in years past.

We’re going to see quite a bit unfold in 2015, especially in the first half of the year, and the industry can’t afford to sit on the sidelines. It’s time to get active in the legislative and regulatory arenas that affect your businesses.

James Gormley
Vice President and Senior Policy Advisor
Citizens for Health

It’s all about the consumer. Natural product marketers and suppliers need to keep the end-user consumer front of mind throughout this coming year and beyond. Consumers drive the changes and trends in products that we have seen over the last decade, whether it is free trade, cruelty free, free of gluten, GMOs, high-fructose corn syrup, or partially hydrogenated fats. We need to recognize that the natural products consumer is savvy, and so we should appeal to this knowledge and discernment in all messaging, including product packaging, labeling, and marketing communications.

Kim Kawa, BSc
Natural Products Specialist
SPINS

The gut-brain connection and microbiome health will continue to cultivate awareness in 2015 and beyond. In 2014, over 14 terabytes of research data became available from the National Institutes of Health–funded Human Microbiome Project. A large global community of scholars has access to a key resource for understanding microbes and their impact on human health and disease. It is exciting to see the puzzle pieces coming together-the role diet plays on gene expression and the links between gut dysbiosis, neurological disorders, and obesity-leading to crucial questions. How are diet and lifestyle considerations evolving by those pioneering the integrative and functional nutrition path? How are new science-backed findings being translated to product innovation in functional food segments and in dietary supplement formulations? Expect more industry focus on a whole-systems approach to the relationship between the digestive and nervous systems. Achieving optimal health by supporting the body’s design is shaping the health and wellness landscape.

Douglas “Duffy” MacKay, ND
Senior Vice President, Scientific and Regulatory Affairs
Council for Responsible Nutrition

FDA’s proposed revisions to the Nutrition and Supplement Facts panels represent a mega issue that will impact the dietary supplement and functional food industries in a multitude of ways, providing both challenges and opportunities. FDA can sometimes take years to finalize proposed rules, but there are rumors that suggest that the label revisions will be fast-tracked because the Obama administration is hopeful that some of the proposed changes may curtail the obesity epidemic. When the compliance date is set, it will be “all hands on deck” for companies. Companies will be reformulating, re-labeling, and trying to educate consumers on an entirely new label. CRN is eager to see how FDA responds to industry comments and is hopeful that several of the FDA proposals are significantly modified in the final rule. CRN is also hopeful that FDA will accept a reasonable compliance date to allow the industry time to make all of the necessary changes.

Irfan Qureshi, ND
Chief Regulatory Officer
Vitamin Research Products

On the regulatory front, let’s continue to hope for more clarity around issues such as the NDI notification process, Good Manufacturing Practices (GMP) inspections, and FDA’s expectations, as well as other regulatory uncertainties that continue to place ingredient innovators in a precarious position. It seems the industry is ready to break out in terms of innovation in several areas but is being hamstrung by an overall perceived lack of guidance from regulators. As industry works through these issues, we are likely to see innovation on several fronts.

Exciting areas in functional foods and supplements include the continued development of probiotics for indications beyond digestive and immune health; an increase in omega-3 sources, including plant-sourced, algal, and phospholipid-enriched; continued upward momentum in protein supplements-plant-sourced is especially trendy-and greens/superfoods; as well as innovative dosing and packaging forms beyond the typical softgels, capsules, and powders.

Additionally, on the legal front it will be important to monitor FDA and FTC actions as well as keep an eye out for states’ attorneys general enforcing the truthfulness of product claims. Another concern for companies should continue to be what seems like the increasing number of class action lawsuits, as these actions will continue to set a precedent for how products can be safely marketed.

Harry B. Rice, PhD
Vice President, Regulatory and Scientific Affairs
Global Organization for EPA and DHA Omega-3s

For 2015, GOED anticipates a flurry of domestic, as well as international, industry-shaping regulatory activity associated with EPA and DHA omega-3s. In February, the Codex Committee for Fats and Oils (CCFO) will continue its discussions and development of a fish oil standard. While Codex is not a regulatory body, many countries use Codex standards as the basis for their regulations. In March, the Dietary Reference Intake (DRI) Committees of the Canadian and U.S. governments are convening a workshop to debate the use of chronic disease endpoints to establish DRIs. GOED is hopeful that following the publication of the workshop proceedings, a decision will be made to launch the next DRI review and that the nutrients chosen will be EPA and DHA. In May, GOED anticipates a decision from FDA concerning GOED’s qualified health claim petition for EPA and DHA and reduction of blood pressure in the general population. In November 2014, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) approved a proposal for new work to establish a Nutrient Reference Value (NRV) for EPA+DHA. An NRV is like a recommended intake used for labeling and health claims. GOED anticipates that this work will begin in July and will take several years to complete.

Andrew Shao, PhD
Vice President, Global Product Science and Safety
Herbalife Ltd.

There are a number of key scientific, regulatory, and policy issues the industry will need to pay close attention to, both domestically and globally. On the domestic front, the industry will need to prepare for the looming requirements of FSMA. This law, with multiple regulations, will be perhaps the greatest compliance challenge for ingredient and food companies. Related to this, the industry needs to watch closely the emergence of the recently named Center for Food Safety and Applied Nutrition (CFSAN) director, Susan Mayne. How will she lead the Center? With her extensive background in nutrition and epidemiology, will she embrace nutrition and natural health products as a way to promote the health of Americans, or will she stick to the status quo of just trying to avoid harm?

Another important FDA rulemaking activity is the revision of the Nutrition and Supplement Facts panels. This is a huge regulation with huge implications on the definitions of certain ingredients (such as fiber and folic acid) and will have a dramatic impact on the labels of both fortified foods and dietary supplements.

On the scientific side, I envision the industry in 2015 engaging more closely with academia via the trade associations to explore ways in which the two sides can collaborate on funding of more relevant research. The industry’s use of “borrowed” science is becoming less and less acceptable, as evidenced by the plethora of European Food Safety Authority (EFSA) negative opinions and FTC enforcement actions. Health benefit claims for products and ingredients need to be supported by studies, the design of which takes into account the claim objective(s) and relevant outcomes a priori. Achieving this will take tremendous collaboration between industry and academia, and will not happen quickly, but this discussion must start as soon as possible.

Globally, a number of key markets are undergoing substantial regulatory revisions around supplements and functional foods. These include Brazil, which is in the process of rewriting its supplement regulations, and China, where a massive overhaul of the food safety law is underway, which will address everything from GMPs and product notification to claims. In the ASEAN region, with the harmonization of health supplement regulations nearly complete, 2015 will be a crucial year as the region looks toward implementation. Look for substantial progress to be made in these markets in 2015.

Maged Sharaf, PhD
Chief Science Officer
American Herbal Products Association

FDA is expected to maintain its focus on the implementation and enforcement of the GMP rules in 2015. Supplement manufacturers must be prepared for FDA inspections of their facilities. One of the more resource-intensive aspects of the GMP rule is the 100% identity verification requirement. Fortunately, the industry continues to develop and strengthen resources to make compliance with this requirement easier for companies.

In 2015, AHPA will continue to add information to its Botanical Identity References Compendium to provide the industry with freely accessible examples of unique identifying characteristics and specific analytical methods used to accurately identify botanicals that are widely available in the commercial marketplace, plant materials known to be subject to misidentification, and several species that are common in various traditional herbal disciplines. AHPA will also continue to provide educational opportunities to inform the industry about the many cutting-edge methods available to ensure compliance with the identity verification requirement.

Brian Tanzer, MS, CNS
Scientific and Regulatory Affairs
The Vitamin Shoppe Inc.

We need to keep a close eye on how dietary supplements are perceived by the media, considering that this is how the public acquires information about dietary supplements. This past year we’ve seen a lot of negative press around dietary supplements (e.g., multivitamins and fish oil). We must be more proactive when it comes to education, and we need to create and maintain solid relationships with scientists, physicians, etc., who can support our efforts in encouraging the use of dietary supplements as part of a healthy lifestyle.

Data is becoming a significant tool for those seeking ways to promote healthy eating, exercise, and stress management. The use of fitness apps and devices such as activity trackers are becoming more and more popular. Companies are now using this data in ways that support health and wellness, and there is a great opportunity for the industry to work with tech companies to be part of this movement towards individualized health and wellness programs. Healthy eating, exercise, and dietary supplements should be at the core of any health and wellness lifestyle, and we have to try to get more involved in this exciting area.

John E. Villafranco
Partner
Kelley Drye & Warren LLP

In 2014, the FTC demonstrated that health-related claims remain an enforcement priority, yet we can expect the debate regarding the substantiation required to support such claims to persist well into 2015. While the FTC Commissioners, at least for now, appear to agree that an order provision requiring RCTs may be necessary in some cases, the Commissioners’ support for such a provision varies by the type of product (e.g., dietary supplement, OTC drug, food) or the type of claim at issue (e.g., disease claim, weight-loss claim). FTC Commissioner Maureen Ohlhausen, for example, has stated several times, including as recently as December 2014, that she is unwilling to support a de facto two-RCT standard for food and other relatively safe products. Likewise, FDA Commissioner Joshua Wright explained in December 2014 that he opposes requiring a fixed number of RCTs, believing instead that effective relief can be achieved with more flexible fencing-in provisions, such as a requirement for human clinical testing that is sufficient in quality and quantity to support the claim, a ban, and/or recordkeeping provisions. Such provisions appear in the i-Health, Norm Thompson Outfitters, and HCG Platinum FTC orders, respectively. Most orders now routinely include a provision requiring the company to obtain and maintain records from clinical trials. All of this suggests that the landscape on this issue is changing, and with cases that focus on this issue currently the subject of litigation and lobbying efforts, we should expect continued development with regard to the substantiation standards for dietary supplements.