From the Trump administration to state attorneys general and the FDA/FTC, here are the key regulatory issues industry leaders are watching in 2017
CLICK ON IMAGES TO VIEW SLIDESHOWNutritional Outlook: What impacts, positive or negative, could the dietary supplements industry face under a Donald Trump administration in 2017?Michael McGuffin
American Herbal Products Association (AHPA)
President Trump’s campaign rhetoric strongly suggests his preference for small federal government, which could mean less pressure on businesses and industries. This may present opportunities to enact improvements to the existing dietary supplement regulatory framework in 2017 and beyond. The dietary supplement industry’s self-regulatory initiatives may also take on even greater importance if president Trump weakens federal regulations. President Trump’s anti-regulatory and anti-establishment posturing suggests the administration will work to bring change. Because it remains to be seen exactly what changes the administration will work to enact, it will be important for the industry to stay actively engaged to identify and take advantage of opportunities and address challenges created by any changes.
Vice President, Global Regulatory & Compliance
United Natural Products Alliance (UNPA)
It’s assumed that a Republican administration will take a more business-friendly approach to regulation. We do know that the Trump transition team has stated that it wants the FDA to promote greater innovation. We are all looking to the new administration for style clues as cabinet members and their federal departments establish priorities and policies.
John E. Villafranco
Kelley Drye & Warren LLP
The most significant impact of the Trump administration will likely be at the FTC. President Trump will appoint new Commissioners, including a new Chairperson. The Chair will then appoint a new director of the Bureau of Consumer Protection (BCP), which has jurisdiction over supplement advertising and labeling.
At the beginning of the last administration, President Obama appointed Chairman Leibowitz, who then appointed David Vladeck as Director of the BCP. That appointment set the direction of FTC enforcement against supplements for the next eight years. And it was a long and hard eight years.
The FTC consistently sought to impose heightened, drug-style clinical trial standards on a variety of health-benefit claims, including claims for dietary supplements. Some companies fought back and litigated against the FTC in court. The FTC won some cases, particularly where disease claims were at issue. For instance, the FTC won the merits portion of FTC v. POM Wonderful where claims to treat or prevent serious diseases, including heart disease and prostate cancer, were at issue. The FTC also won where a company had claimed that its product was a “clinically proven natural solution to diabetes.”
The FTC, however, consistently lost where it sought to impose heightened standards on non-disease structure/function claims and defendants offered credible expert testimony in defending themselves. First, the FTC lost at the 11th Circuit in FTC v. Garden of Life, where cognitive-function claims for a children’s omega product were at issue. Next, the FTC lost Basic Research v. FTC where weight-loss claims were at issue. Finally, the FTC lost FTC v. Bayer, where it had challenged claims that a probiotic would improve digestive health. The courts in each of these cases found that the FTC had sought to enforce a substantiation standard that moved beyond its own guidance on the “competent and reliable scientific evidence” standard. The courts wouldn’t allow that. To be sure, the FTC won a couple cases on non-disease claims, but those cases involved claims like “reverses gray hair,” and the defendants offered no science or expert testimony.
It’s hard to imagine that the new administration would have the same appetite as the outgoing administration to enforce stringent clinical trial standards in cases where companies have offered credible science and qualified experts in support of their claims. We expect the new administration to be more interested in encouraging those types of companies-and fostering innovation and business growth.
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Nutritional Outlook: How might the new Congress positively or negatively affect the dietary supplements industry in 2017?Michael McGuffin: Trump’s anti-regulatory impulses could be reinforced by the Republican-controlled Congress. Republicans’ general aversion to federal regulatory intervention may present opportunities to enact improvements to the existing dietary supplement regulatory framework in 2017. A Republican-controlled House and Senate could also create a more favorable climate for fending off anti-supplement policy efforts by the industry’s very few congressional detractors.
Larisa Pavlick: Congress will be very busy dealing with issues related to the Affordable Care Act, which will take up a lot of the healthcare “oxygen” in Washington. We do know that we’ll need to continue to educate Congress about our issues and look to create positive opportunities. Very few of the current members of Congress appreciate the need for the regulatory structure we have as they were not in Washington in 1994 when the Dietary Supplement Health and Education Act (DSHEA) was passed.
Kelley Drye & Warren LLP
Critics of the industry often decry DSHEA as too lenient and push for amending the law to be tougher on dietary supplements. Senators Richard Blumenthal (D-CT) and Dick Durbin (D-IL), for instance, have pushed to amend DSHEA. Senator Claire McCaskill (D-MO) has also been a vocal critic of the supplement industry and called for tougher regulation. With the current Republican-led Congress, DSHEA is very likely to remain the law of the land.
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Nutritional Outlook: Which key FDA or FTC actions or deadlines should the supplements industry be on the lookout for in 2017?Michael McGuffin: The FDA has begun implementing the Food Safety Modernization Act (FSMA), and most ingredient suppliers in the dietary supplement industry will be impacted as the law is fully implemented in the coming years. The American Herbal Products Association (AHPA) is working to help those in the industry understand who will be affected by FSMA and what they need to do to comply with their obligations and provide a roadmap to compliance.
The industry will also be following any new action by FDA as it works to finalize guidance for New Dietary Ingredients (NDIs). AHPA will continue to advocate for guidance that will achieve FDA’s stated goals of improving the rate of compliance with the NDI notification requirement and the quality of notifications. Despite the fact that FDA’s revised draft guidance needs improvement, responsible companies can still navigate NDI requirements successfully-as several AHPA members have done-in order to continue to meet consumer demand for innovative products.
Larisa Pavlick: In 2017, there are several compliance dates to be aware of and to prepare for, including:
1) Nutrition Facts labels: The compliance date for the use of the new labels is July 26, 2018. For firms with less than $10 million in annual food sales, the compliance date is July 26, 2019.
2) FSMA: FSMA affects all manufacturers of food products, including dietary supplement raw-material suppliers. FSMA has seven parts. We believe one of the seven will have the largest effect on our members in 2017: Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food Risk (21 CFR Part 117). For some facilities, the compliance date was September 2016. For others with less than $1 million in sales, the compliance date is September 18, 2017. For facilities with less than 500 full-time employees, the compliance date is September 18, 2018.
3) Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) (21 CFR Part 1): The compliance date for FSVP is May 28, 2019.
Katie Bond: Companies will need to continue to adjust compliance in light of FSMA and the new nutrition labeling rules, which were finalized under the Obama administration. The FDA’s NDI guidance may also be finalized in some form at some point.
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Nutritional Outlook: What attorneys general actions, if any, should the supplements industry be on the lookout for in 2017?Larisa Pavlick: At the United Natural Products Alliance (UNPA), we are watching the recent regulatory news for Prevagen. [Editor’s note: On January 9, the FTC charged Prevagen with making false and unsubstantiated claims for its brain-health dietary supplement.] Our interest is focused on the type of action taken. It is interesting that the current regulatory measures were taken by FTC and the New York attorney general and not by FDA. FDA issued a warning letter to Quincy BioScience Manufacturing (the brand owner and manufacturer of Prevagen) in October 2012. This warning letter was in response to an inspection conducted at the end of 2011. The recent joint regulatory enforcement action announced by FTC and the New York attorney general in January 2017 comes nearly five years after the violative FDA inspection.
We would expect that any regulatory void from FDA during the new administration would be filled by other agencies. The joint action against the Prevagen product this week is a great example.
Also, we will continue to watch and evaluate the implications of the New York attorney general and GNC and NBTY settlements.
John Villafranco: The California District Attorneys and the Office of the New York Attorney General will no doubt remain active in enforcement against dietary supplement marketers. The Iowa attorney general, in the last year, has become particularly active, as well. In September 2016, the Iowa AG announced a settlement with a company over bladder-control claims for dietary supplements. The same month, the Iowa AG also announced a settlement with Walmart over a statement, “Verified by an independent, certified laboratory,” which appeared on labels of its store-brand supplements. The AG contended that the statement exaggerated the level of testing backing the products.
Michael McGuffin: AHPA has partnered with others in the industry to develop relationships with state attorneys general and inform them about the industry and how it is regulated. We are optimistic that this outreach is the beginning of a long-term relationship between the industry and these state regulators that will help further our shared goals of ensuring consumers have informed access to high-quality and safe dietary supplement products. Companies looking to participate in or support these industry efforts should contact AHPA.
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Nutritional Outlook: The public comment period for FDA’s new dietary ingredient draft guidance closed in December. Do you anticipate any FDA NDI-related actions in 2017?Katie Bond: It will be interesting to see how the saga of the NDI guidance plays out and whether a shift in leadership at FDA will make a difference.
Vice President, Regulatory and Scientific Affairs
Global Organization for EPA and DHA Omega-3s (GOED)
Given the change in administration and limited resources, I suspect little will happen in the way of enforcement. At this time, I think the FDA needs to take the comments it received and determine if it’s going to either redraft or finalize the guidance document. That, in and of itself, will be a monumental task.
Michael McGuffin: AHPA has communicated to FDA that the latest version of this draft guidance is unlikely to achieve the agency’s stated goals of improving the rate of compliance with the NDI notification requirement and the quality of notifications. AHPA has also expressed concern that the 2016 revision of the draft guidance is contrary to the intent of the law in numerous areas and would unnecessarily burden the industry. AHPA will continue to advocate FDA to revise this guidance so it will better achieve FDA and the industry’s shared goals and meets the intent of the law.
Despite the fact that FDA’s guidance needs improvement, responsible companies can still navigate NDI requirements successfully-as several AHPA members have done-in order to continue to meet consumer demand for innovative products.
Larisa Pavlick: Yes, we anticipate NDI-related regulatory action in 2017. In fact, regulatory action has already been taken. Based on a recent meeting with FDA, we understand that the agency plans to issue the revised guidance by the end of 2017. New leadership at the Office of Management and Budget may well be looking more closely at the economic impact of the draft guidance on businesses and jobs, which could have a major impact on what finally happens with the guidance.
But a final guidance isn’t necessary for FDA to continue to enforce the new dietary ingredient statute and notification process found in Section Eight of DSHEA. New dietary ingredients are also found in the Federal Food, Drug, and Cosmetic Act, Subchapter IV-Food Sec. 350b â New Dietary Ingredients, with an effective date of January 7, 2011.
The current and the anticipated final guidance document is a tool; however, it is not legally binding. Guidance documents published by FDA are designed to provide administrative direction and to convey expectation to the field investigators and the industry. Regardless of the finalization of the guidance document, the underlying public law related to new dietary ingredients and the notification requirement will not change.
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Nutritional Outlook: We ended 2016 with a couple of big regulatory developments, including the DEA’s proposal to schedule kratom constituents mitragynine and 7-hydroxymitragynine as Schedule I drugs, as well as indications that FDA could try to reverse the dietary ingredient status of vinpocetine. What are the biggest U.S. regulatory issues the supplements industry should keep an eye on in 2017?Michael McGuffin: AHPA has expressed concern about the DEA effectively banning a plant [kratom] that is currently on the market by scheduling naturally occurring constituents of that plant under the Controlled Substances Act (CSA). AHPA also urged DEA to refrain from taking any action that would limit research into the benefits and risks of a botanical. Restricting research is a disservice to consumers, especially those who may benefit from using the plant.
AHPA has recommended the Secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be a lawful dietary ingredient. In addition, AHPA encouraged FDA to clarify that if vinpocetine is either found to be currently in the market as a food ingredient or comes to be included as a food ingredient in the future, the ingredient would therefore qualify as a dietary ingredient.
These issues were not resolved in 2016 and will continue in 2017. AHPA will continue to be vigilant on these issues and emerging issues to quickly respond to attempts by federal regulators to reduce access to herbal and herb-derived products.
John Villafranco: Potential safety issues will likely continue to prompt regulatory action. We saw this with the two ingredients you mention. We’ve seen this for years with other ingredients like ephedra and DMAA.
Companies will also want to keep an eye on blue-state AGs, who will likely attempt to pick up the perceived slack in federal advertising enforcement, assuming that the FTC will be less aggressive under the new administration.
Larisa Pavlick: So much depends on how the new administration shapes up and how new leadership at FDA and FTC will set priorities. We could see some pretty substantial shifts in priorities from the last eight years. Having said that, from our standpoint, the biggest regulatory issues the supplement industry should keep an eye on in 2017 include NDI notifications, risk-based preventive controls for human foods, and unapproved health claims.
Regarding NDIs, the underlying law related to notification requirements is not being reviewed. Finalizing the guidance will not change the industry’s regulatory obligation to file a notification for an NDI. At UNPA, our goal is to learn more about the expectations of FDA for reporting, by reviewing the law and monitoring NDI notification submissions. We will share this information with our members to help them to be more prepared.
We think other critical areas covered in the NDI draft guidance will evolve over the year, and those expectations will become more defined after the comments have been reviewed and evaluated by FDA. Some areas we see developing include the creation of an [Old Dietary Ingredients] ODI list, a more complete definition of a “manufacturing change,” expectations for nanotechnology and synthetic botanicals, and new notification requirements relating to dietary ingredients versus a dietary supplement.
Risk-based preventative controls will affect all companies manufacturing, packaging, holding, or distributing food products, including raw materials for use in dietary supplements. Some of the requirements of preventative controls will be new to our members and the industry at large. We will work with our members to help them navigate, write, and implement a food-safety plan and modify procedures and policies within their organization to meet these new expectations.
Finally, false or misleading claims seem to be receiving media attention more frequently lately. FDA issued approximately 83 warning letters related to health fraud in 2016 compared to about 72 in 2015. These decisions were based either on FDA inspections or from the review of company labeling and websites. In addition to this FDA action, FTC and state AGs seem to be paying more attention to health claims.
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Nutritional Outlook: In terms of global regulations, what are the biggest developments to watch for in 2017?Katie Bond: Companies will need to keep an eye on trade matters, particularly with regard to China. Actions by the new administration to change China’s trade practices could have implications for the many companies that buy ingredients from China
Harry Rice: The Codex Alimentarius Commission (CAC) is an international food (including dietary supplements) standardâsetting body, but many countries adopt the standards, in part or whole, as regulations. While many people aren’t aware of the CAC, this is a very influential organization. For the last couple of years, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) has been discussing the adoption of a nutrient reference value non-communicable disease (NRV-NCD) for EPA+DHA [omega-3 fatty acids]. Obviously, its adoption is very important for the omega-3 industry, but what many people don’t realize is that it is equally as important for the rest of the dietary supplement industry. Success means an increased likelihood for future discussions about the adoption of an NRV-NCD for other “non-essential” nutrients and bioactives. Failure will make it all that much more difficult to stimulate such discussion. Unfortunately, given the unfathomable politics, the fate of an NRV-NCD for EPA+DHA is uncertain.
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Nutritional Outlook: The dietary supplements industry will likely still have its share of critics and negative press in 2017. What are the most important areas industry members need to focus on in 2017 in order to retain consumer trust in the face of industry critics?Michael McGuffin: The dietary supplement industry has always had a few outspoken critics, but consumer demand for high-quality products continues to outweigh the efforts of these critics. The industry should focus on meeting consumers' growing demand for high-quality, sustainably produced products from socially responsible companies. If the industry continues to do these things, it is likely that consumers will continue to ignore a few vocal critics.
Larisa Pavlick: Industry needs to continue to focus on quality in its manufacturing operations and to manage its supply chains. UNPA is working closely with industry and other organizations to continue to raise the quality bar. When dietary supplement products are pulled from retail shelves by third parties, it makes for an easy target when the products are tested and they are not in compliance with their labeling. Ethical companies have the power and control to ensure their products meet label claims as declared in the supplement facts box on their finished product.
We are currently reviewing the report that tested melatonin supplements and found sub-potent products. Many of these issues are related to four elements: identity, purity, potency, or composition. Purity can be anything from potential contaminations, such as heavy metals, microbiological contaminants from food pathogens, or pesticide residues. These four required elements for monitoring finished products are all addressed in the dietary supplement good manufacturing practices (GMPs). At UNPA, we will work with our members to ensure they have a full and complete understanding of each of these four elements and will provide subject-matter experts during training.
By standing behind the products we manufacture and distribute, we can improve consumer confidence.
Harry Rice: While the vast majority of the industry sells high-quality products backed by sound scientific substantiation, it’s the random bad apples that give the industry a bad name. Thus said, the industry as a whole needs to continue to focus on manufacturing the highest-quality products possible and only making claims that are backed by sound science.
John Villafranco: Product safety has to remain the number-one priority. Making sure claims are substantiated will still also be a priority. Even with a less-aggressive FTC, state AGs and self-regulators, like the [Better Business Bureaus’ National Advertising Division; NAD], will remain active. Companies will also want to remain vigilant in policing competitors. Different circumstances will call for different actions, such as alerting regulators of violations, sending a demand letter, or filing an action at the NAD or in court.
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Nutritional Outlook: Do you feel like this is going to be a good year for the dietary supplements industry?John Villafranco: Yes, the change in the administration is likely to be a game changer for the supplement industry, given the impact on FTC enforcement. The new administration is likely to adhere to the current FTC guidance on dietary supplement claims and the traditional understanding of “competent and reliable scientific evidence.” Companies will still have to vet their substantiation carefully, but will be able to have greater faith that if they meet existing standards, the likelihood of enforcement will be low. Enforcement by the FTC can be devastating for companies. With less risk on that front, companies will have greater latitude to innovate.
Harry Rice: Every year presents new challenges and opportunities, but it’s clear that people want to take responsibility for their health, and those doing so strive to eat a well-balanced diet, maintain an active lifestyle, and take high-quality supplements. The bottom line is that with the ever-increasing recognition of the benefits of health promotion and disease prevention that it should be a good year for the dietary supplement industry.
Larisa Pavlick: Signs continue to point to continued, positive market growth for responsible industry and its products. We are hopeful that the industry initiatives that have been implemented and that are due to come online in the near future will help improve the overall quality of supplements on the market. We are fully supportive of appropriate regulatory action against bad players and illegal products to remove them from the market. We are hopeful that the vast majority of companies in the industry will continue to serve as examples of how safe, quality dietary supplements can be an important part of consumers’ healthy lifestyles.
Michael McGuffin: The dietary supplement industry continues to grow and build momentum and there is no indication that this trend will stop in 2017 or future years. Younger generations are increasingly interested in maintaining health and well-being using supplements. The industry can expect continued growth as these younger generations mature and the benefits and safety of dietary supplements are increasingly documented.
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