When it was announced that the U.S. Food and Drug Administration (FDA) was releasing its latest Draft Guidance of New Dietary Ingredient (NDI) Notifications, the industry held its breath. The original 2011 draft left much to be desired and naturally, there was a great deal of concern. Its release was met with both skepticism and hope. “Initially when we saw the document, a lot of the principles FDA had laid out in the original had not shifted that much,” explains Duffy MacKay, N.D., director of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), Washington D.C. “However, as we looked closer at the document, we realized, and as we read the document, we could clearly see the areas which FDA listened to the industry, listened to our comments.”
This however, is only one perspective. Others did not approach the latest with pleasant surprise, but rather anger and deep worry. WholeFoods’ own columnist Scott C. Tips, for example, lambasted the guidance. This is, after all, a consequential document because ingredients marketed safely for years but otherwise have not undergone a New Dietary Ingredient Notification may now be considered adulterated. This could be highly detrimental to dietary supplement businesses and considering industry members’ legitimate concerns, FDA’s choice on how to approach this issue was paramount. Enter Cara Welch, Ph.D., senior advisor for FDA’s Office of Dietary Supplement Programs and WholeFoods’ 2016 Person of the Year.
These have been trying times for our industry. We have fought and will continue to fight to be recognized as legitimate and responsible, against attacks from the press and regulatory forces. But as we defend our interests in light of the NDI draft guidance, it helps to have people on the other side of the aisle who we can work with. Cara Welch is someone who has proven herself to be a reasonable and thoughtful regulatory figure with a deep understanding of our industry, having once lobbied for dietary supplements as part of the Natural Products Association (NPA), Washington, D.C.
When she has spoken at events such as SupplySide West in Las Vegas, NV about the NDI draft guidance, rather than just lecturing the industry, she explained FDA’s position, addressed our concerns, listened to our questions and made an effort to clearly answer them. “With previous and other FDA officials, an answer to a question was more like a head butt,” explains MacKay. “It was disrespectful to the industry and it just didn’t create the environment that we are all working together to create a safe supplement or market.”
Instead, Welch provides a model for how FDA can effectively communicate with our industry that is not pandering, but rather a thoughtful dialogue. This does not always end with agreement, but certainly mutual respect. Let’s explore Welch’s career and the ways she has been involved with the NDI draft guidance both within and outside of the dietary supplement industry, as well as the qualities that make her WholeFoods’ Person of the Year.
NDI Draft Guidance and Cara Welch, a History
A New Dietary Ingredient Notification is much like it sounds, but has taken a few forms over time. When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law, it modified the Food, Drug and Cosmetic Act (FDCA) by adding section 413 which defined a new dietary ingredient as one not marketed prior to October 15, 1994, when DSHEA was signed (1). The section required manufacturers and distributors to follow a specific process when marketing an NDI, but related only to notifications and did not give FDA power of premarket approval.
In September 1997, FDA issued a Final Rule on Premarket Notification of a New Dietary Ingredient which laid out the procedure by which manufacturers or distributors submit information that demonstrates a dietary supplement with NDI is “reasonably expected to be safe” (1). However, industry still required additional guidance about clarifying whether an ingredient was in fact new and warranted notification. On January 4, 2011, President Obama signed the Food Safety and Modernization Act (FSMA) that under section 113 required FDA to issue a guidance document on NDI notifications. This was to clarify when an ingredient is considered NDI and when information on NDI was to be submitted. The guidance was released in July 2011.
Between 1994 and 2011, the dietary supplement industry saw a great deal of growth and innovation, with about 55,600 dietary supplement on the market and 1,000 new ones being added each year at that time. However, by 2011 only 700 NDI notifications were submitted since the process began, meaning there were likely a great deal of manufacturers that either did not know their product contained an NDI or chose not to disclose it. Consequently, the draft guidance served to help industry comply, but also had the potential to create major setbacks for dietary supplement makers if they were selling products that were determined to contain NDIs. At the time the initial draft guidance was released, Welch was the vice president of scientific and regulatory affairs a NPA, advocating on behalf of the industry for major revisions to the draft guidance.
Among the things Welch—on behalf of NPA—was advocating for were changing the level of testing data required for the notification—which was on par with food additives—and evaluating the need for product-specific notifications, which would be duplicative and remove the burden of proof from the industry to demonstrate use of pre-DSHEA ingredients. Welch, in collaboration with Liz Hurst, government relations manager at NPA, laid out the trade association’s argument in an article published by the Food and Drug Law Institute (1). “The dietary supplement industry is already regulated by FDA, and has been operating under the NDI submission process since the enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994,” they write. “The guidance document should not substantively change the law but merely elucidate FDA’s thought process. The Natural Products Association (NPA) believes that FDA has stepped over this line and strayed from the original intent and spirit of the law.”
For one, they explain, FDA’s use of food chemical references from the Food Additives Safety division was not in line with the parameters of DSHEA, which does not hold dietary supplements to the same standards as food additives. Despite FDA’s explanation that this only serves as a useful guideline, it is misleading to dietary supplement manufacturers. Second, considering the number of dietary supplement formulas that feature the same ingredient from any given company, submitting a notification for each one would not only be duplicative but exceptionally costly. And third, by placing the burden of proof on industry that an ingredient is pre-DSHEA, individual companies that are unable to dig up records or simply do not have them would then have to submit notifications or take products off the market.
In its response to the NDI draft guidance, submitted over 7,000 comments, hoping that the overwhelming response would motivate FDA to reconsider and change its stance. Welch was a vital component of this industry effort. “I feel like my time at NPA gave me a comprehensive understanding of [FDA’s] impact on the various firms—the different type and sizes—in the regulated industry and I think it forced me to consider the various ways those regulations and guidance documents and other agency decisions can influence our industry,” says Welch.
She began at NPA as scientific and regulatory affairs manager in 2009 after earning her Ph.D. in medicinal chemistry from Rutgers University. Her initial exposure to dietary supplements was scientific, conducting research on traditional medicinal African plants under the direction of James E. Simon, Ph.D., Rutgers’ Department of Plant Biology and Pathology.
She knows this industry, represented the industry, knows the issues, knows the
science; but in addition to Cara’s credibility is that she has good soft skills. She has the ability to communicate the message of FDA without a chip on her shoulder and presents it in a logical way, she presents it in a rational way, she’s unapologetic, she can answer an industry question knowing what that person is thinking.
— Duffy MacKay, N.D., CRN
At NPA, she began her career by working on the Natural Seal Certification Program and the dietary supplement GMP certification program which exposed her to GMPs and the way products go through the regulatory process to be marketed as dietary supplements. When she was promoted to VP of scientific and regulatory affairs, she became responsible for implementing policies in response to government initiatives and advising association members on regulatory, safety and health issues.
These were formative years for Welch as she grew as an industry professional, listening to our concerns, fighting our battles and helping us find solutions. It was only natural that she move on and pursue helping the industry in other ways. While our relationship with regulatory agencies can often be contentious, it is refreshing when we can be civil and work together. Five years after the original NDI draft guidance, the new draft was released on August 11, 2016, this time with Welch on the other side of the regulatory aisle.
Welch began at FDA in early 2014 as a regulatory project manager before moving on to be branch chief of the regulatory implementation team within the Division of Dietary Supplement Programs, as it was known before it became the Office of Dietary Supplement Programs. She was briefly the acting director of the division and now functions as the office’s senior advisor. “I have had the opportunity to oversee a lot of the office’s policy moves, the guidance documents or regulatory documents we’re putting together,” says Welch, of her role at FDA. “I’m still quite involved in the cGMP activities for the office. We are doing a lot of work for enforcement on cGMPs.”
In some ways her work is similar, in that she must consider the impact of regulation on the industry, only now from a regulatory perspective where authority is wielded rather than defended against. “I think my time at FDA has given me a better understanding of how we can use our authority to protect the public’s health and ensure product integrity and quality as well as how we can’t,” says Welch. “It has reinforced the need to understand how a regulation, a preamble, a guidance, a warning letter, or other agency statements affect the industry as well as products’ commerce.”
Cooperation Despite Differences
The latest NDI draft guidance is far from perfect but it appears that FDA has listened. For example, some of the core issues brought up earlier have been updated, such as FDA’s intention to develop a master file of grandfathered ingredients and umbrella submissions rather than product-specific notifications. It is still industry’s responsibility, however, to seek further information and encourage debate on the issue. NPA was recently able to extend the comment period for the NDI draft guidance in an effort to make industry’s voice heard and engage FDA on outstanding issues. “While there were some positive take home messages in the way of master file, industry now needs guidance on how FDA will set up such a master file system for NDIs,” explains Daniel Fabricant, Ph.D., executive director and CEO of NPA. “Will industry just submit under their old NDIs or will FDA have to create unique dockets for companies to upload their CCI data?”
Another major point of contention regards botanical ingredients, specifically synthetic constituents of botanicals. FDA in the NDI draft guidance states that a synthetic constituent is not a dietary ingredient and therefore not eligible to submit a notification and considered adulterated. “CRN members think that if you can demonstrate substantial equivalence to a compound that’s found in plants, for example EGCG which is found in green tea, and if you can actually make it some other way and it’s substantially equivalent, then it shouldn’t preclude it to be reviewed as a new dietary ingredient,” explains MacKay. “We would like to see FDA at least be willing to evaluate those ingredients, look at the safety data and determine whether they can be a dietary ingredient based on that.”
Ultimately total agreement is unlikely, but that’s not the point. “The stakeholder community might not be completely happy with FDA’s position, but hopefully they understand why we have this position, and we can move forward from that point,” states Welch. MacKay is on the same page. “I think there is stark disagreement in some areas and there will continue to be stark disagreements and we appreciate where FDA has provided additional clarification on their thinking, which even though we disagree, it is helpful because we can understand where they’re coming from, whether it’s a safety concern or whether it’s based on a statute,” says MacKay.
I think my time at FDA has given me a better understanding of how we can use our authority to protect the public’s health and ensure product integrity and quality as well as how we can’t.
— Cara Welch, Ph.D.
While the draft is not yet final, it is a good indication of how we likely have to operate. And despite what we may not like, many in industry agree that NDIs are important and necessary. “Safety is a top priority and when you create a new ingredient, or introduce a new ingredient to the marketplace, if you think about it from a public health perspective, you need some evidence that it’s safe and the NDI process is the only chance for premarket review of evidence before it is consumed by consumers,” explains Duffy. “So that single reason really makes this document important because it defines the scope and breadth of products that need to be funneled through this premarket process.”
Fabricant concurs. Ultimately, as a responsible industry that has historically taken steps at self-regulation, an NDI draft guidance is important to have. “Industry wanted guidance on NDI notifications, and responsible industry tends to want to know how to go about doing something rather than cast aspersions on the Agency,” says Fabricant. “Also, while a guidance isn’t enforced by FDA, it is a binding norm that states (Attorneys General) and the plaintiff bar attorneys use to attack companies for incredible sums of money every year. So if it isn’t really the best practice but sets up an expectation as one, it’s easy pickings for really horrible trial practices.”
That is why we are actively debating the document, so that we can strike the right balance. If definitions that require NDIs are too broad then a lot of ingredients will have to undergo this process and if the definition is too narrow, too few will undergo it, explains MacKay. The NDI will not have a positive effect if it’s too draconian or too lenient. Of course, the document has its own limitations.
“I think it’s also important to realizing the practical limits to what a guidance can do,” explains Welch. “An example of this is that FDA writes guidance documents for the masses, you can’t include every specific situation, every product formulation or dietary ingredient manufacturing change. We think it’s really important that we’re willing to engage with these stakeholders so that we can help them as they try to comply.” Essentially, she explains, if you know a better way, let’s talk about it.
Welch has been a centerpiece of this engagement, conducting webinars and presenting at industry events such as this year’s SupplySide West. She gives FDA a face for industry to communicate with and with her experience at NPA, is empathetic. “I think Cara has great credibility with the industry,” says MacKay. “She knows this industry, represented the industry, knows the issues, knows the science; but in addition to Cara’s credibility, she has good soft skills. She has the ability to communicate the message of FDA without a chip on her shoulder and presents it in a logical way, she presents it in a rational way, she’s unapologetic, she can answer an industry question knowing what that person is thinking.”
MacKay relays an anecdote to me about meeting with a CEO who read the NDI draft guidance and was so concerned he flew to the U.S. to hear about draft from FDA itself, specifically from Welch. “He arrived, listened to the talk at SupplySide West and he left feeling much more reassured that FDA was really willing to be reasonable,” MacKay tells me. “So he actually saw it as more of a positive thing and it was the same information he saw on paper but I think it was her delivery of it that really allowed him to say, ‘You know what, this is an agency that I’m willing to work with.’”
While looking down the barrel of the 102 page document can seem daunting, Welch wants industry to realize it’s not so scary once you dig into it. And as much as industry appreciates FDA’s efforts to educate us, they in turn encourage and appreciate the feedback. “We want a guidance document to aid industry and stake holders with complying and if it’s not helpful we need to hear that,” says Welch. “We’ve received some positive responses, we’ve received some negative responses of course, and we’ve received some response that said ‘This is the way it is and we need to figure out how to move ahead.’ Those are the one’s I’m really looking forward to working with.”
Cooperation is key, because while Welch understands our industry and is sympathetic to it, she does not speak for us. “She’s not our ally in that she’s going to fight our fight, but she’s got a synergy,” explains MacKay. “When she sees us doing something that is going to help her, I’ve seen her become more receptive than previous offices and divisions.”
It’s also important to recognize that Welch is a single member of a team. However, as someone who has been persistently engaging with industry, listening to our concerns and in some cases soothing them, Welch is certainly deserving of being recognized as WholeFoods’ 2016 Person of the Year. WF
1. C. Welch and L. Hurst. “Does the NDI Draft Guidance Significantly Impact the Safety of Dietary Supplement?” FDLI. 1(22). 2011
Published in WholeFoods Magazine December 2016