As the food industry lurches from scare to scare, the dietary supplement industry waits for the dust to settle on the FSMA and, maybe, thinks it’s time to feel good about itself.
The Participants Are:
• Daniel Fabricant, PhD, Executive Director and CEO
Natural Products Association (NPA)
• Duffy MacKay, ND, Senior Vice President, Scientific & Regulatory Affairs
Council for Responsible Nutrition (CRN)
• Michael McGuffin, President
American Herbal Products Association (AHPA)
• Justin J. Prochnow, Shareholder
Greenberg Traurig LLP
• Scott C. Tips, JD, President
National Health Federation (NHF)
NIE: The Peanut Corporation of America (PCA) shut its doors in 2009 after a 2008 outbreak of Salmonella typhimurium killed nine people and sickened 714 others, making it the deadliest salmonella crisis in recent years and resulting in one of the largest food recalls in American history. In September 2015, Stewart Parnell, the PCA’s former president, was essentially sentenced to life behind bars for knowingly shipping out the contaminated products.
A federal magistrate handed Parnell a 28-year prison sentence, the strongest penalty ever for a company executive in a food-poisoning outbreak. His brother and food-broker Michael Parnell was hit with a 20-year sentence, and the plant’s quality assurance head, Mary Wilkerson, received five years.
In 2014, Eric and Ryan Jensen, brothers who owned and ran Jensen Farms in Holly, CO, each received five years probation, six months of home detention, fines and restitution for their role in a listeria outbreak in improperly cleaned cantaloupe that killed 33 people in 2011.
Chipotle Mexican Grill is the most recent food-safety crisis. Two Escherichia coli outbreaks in late 2015 sickened 60 people across 14 states and, in December, about 140 people in Boston, MA reported feeling sick as part of a norovirus outbreak at a Chipotle there. Panera Bread is now investing more in food safety as a result of Chipotle’s series of problems.
What takeaway do all of these food-safety disasters offer to the health-food industry?
Fabricant: I think it has put the spotlight on companies to hire micro and food toxicologists. We take them for granted because maybe the focus for a company has been to get their QA/QC really tight. When you tally all the numbers from drug adverse events submitted to FDA (U.S. Food and Drug Administration) with numbers reported from outbreaks to CDC (U.S. Centers for Disease Control and Prevention) and the reportable food registry for conventional foods, and you compare those to the number of voluntary reports and mandatory serious adverse events reported for dietary supplements, people don’t realize how much safer supplements are in comparison to the other two. NPA tracks those valuable statistics for its members so that we can combat the negative attacks against our industry by those on the outside who don’t really understand that dietary supplements are regulated. What separates the dietary supplement industry from conventional foods at this point is that dietary supplements are the only commodity of food at present to have a mandatory reporting requirements for serious adverse events. When a tox signal lights up, I think FDA is ready to do something about it like DMAA (1,3-dimethylamylamine, methylhexanamine or geranium extract). Foods relies on outbreak data reported to CDC, which is already too late to stop it at an earlier point in time, and to a lesser degree on their data from the reportable food registry. When you compared GMPs (good manufacturing practices) between conventional foods and dietary supplements, there is no comparison. Dietary supplement cGMPs were patterned after the drug industry. The dietary supplement cGMP playbook for part 111 (21 CFR Part 111. or CGMPs) is 813 pages. The rule for conventional foods pales in comparison. I think that is another major contrast.
Prochnow: The recent food-safety scares indicate the continuing need to stay on top of the manufacturing and suppliers of ingredients. And also, that you can do all you can, and you still may be faced with a recall situation. We have many recall situations of late where a company received an ingredient from an ingredient supplier. The ingredient came with a COA (certificate of analysis) and a clean bill of health from the supplier. The company tested the ingredient and it passed with no contamination. The ingredient was used in products, which were also tested before being shipped. Then, the company gets notice from its ingredient supplier that another customer of the supplier tested the ingredient and it tested positive for salmonella. Then every company along the chain and companies along other chains using that same ingredient are looked at to recall product. Of course, FDA is doing this to ensure consumer safety. But companies that test the product over and over are forced to spend, time, money and energy and there is really no way to prevent it. So, the biggest takeaway is that companies must be prepared. Companies should have SOPs (standard operating procedures) in place and plan of action in case a food contamination issue happens at their own facility or from an ingredient supplier. Companies should be running mock recalls. And, companies should have a PR strategy in place. While a company like Chipotle is likely to be able to weather the storm over time, smaller companies are unlikely to be able to stay in business. Having a strategy in place with people experienced in dealing with such situations is an important facet of the plan.
NIE: Has consumer trust in prepared foods been grievously harmed? What about consumer trust in dietary supplements and functional foods/beverages—any fallout?
Fabricant: You will always have these issues creep up from time to time. I think most people have faith that their food is fine. There are federal regulations to follow. There are the new preventive controls for ingredients in place. Safety is getting better over each decade, not worse, and that is the expectation of the public.
Prochnow: No, I don’t believe that consumer trust in prepared foods has been grievously harmed. While it has probably hurt Chipotle’s business short term, I would imagine that, long term, people will forget those issues. I think that most people realize that there are going to be contaminations from time to time. People still eat peanut butter, spinach, eat at Taco Bell, and even have cantaloupe here in Colorado. Ironically, while safety issues should be a bigger concern, I think people continue to be more skeptical about the claims being made on products. In my opinion, actions by the New York attorney general and others have caused people to question more about what is actually in products than being concerned about the safety.
Tips: Absolutely it has. But I do see that this has been largely limited to prepared foods at specific restaurants such as Chipotle, with a lesser degree of fear attaching to other such restaurants. I do not see that it has affected food supplements or functional foods and beverages. Still, as with what happened to Jack in the Box when it had its own meat contamination issues some years ago, this too will eventually pass for Chipotle if that restaurant’s management employs a good damage-control team and implements the correct food-safety measures.
NIE: What, generally and specifically, is the industry doing to make safer products, comply with government food-safety regulations and regain (or maintain) consumer confidence?
Fabricant: FDA has mandatory recall authority, and they have used it for supplements. I was the first to use that authority at FDA. There have been voluntary recalls performed. These are all the same things conventional food companies have been expected to do, and you can contrast the adverse events [among supplements, foods and prescription drugs].
NIE: How has the natural products industry been affected since the enactment of FSMA?
Fabricant: I think very little is the answer. NPA has asked FDA on where they are in terms of their inspections of ingredient suppliers. How will FDA enforce the new FSMA (Food Safety Modernization Act) rules? When will they roll it out? How many inspectors will be tasked to inspect dietary ingredient suppliers domestically and more importantly, in foreign governments like China and India? No one knows. It is the great elephant in the room that no one is talking about in an open forum. We have asked FDA for a special FSMA session related to dietary ingredients used in dietary supplements. They have held special FSMA engagements in public stakeholder meetings on every other aspect from FSMA except dietary ingredients. I think FSMA also places heavy burdens on the manufacturer once again to verify aspects of their ingredient supplier. It is a passing of the buck onto manufacturers. We will see how this all plays out soon, but it seems like a non-level playing field. It is crucial for it to be addressed in a meeting with FDA on dietary ingredients.
MacKay: As the compliance dates for various parts of the law are staggered, it’s fair to say that it’s too soon for the dietary supplement industry to have seen or to evaluate the true impact of FSMA. But our hope is that over time, this law will have a major impact on the entire food industry—including dietary supplements—and that impact will benefit both consumers and industry in a positive way. We’ve already seen some implementation that should provide increased efficiencies for FDA enforcement. For example, the requirement for bi-annual registration of facilities was enacted immediately and we’re supportive of that change in the law because it allows FDA to respond to a food-related emergency quickly and efficiently. We also saw FDA use its new authority granted by FSMA for administrative detention—this new tool allowed FDA to essentially remove ingredients like DMAA and Kratom [Mitragyna speciosa] from the market. As regulators, the agency needs these tools, and as industry, we should support removal of ingredients from dietary supplement products that don’t meet legal requirements and may pose a threat to consumer safety.
McGuffin: The full effects of FSMA on the natural products industry won’t be fully known until all of the rules are implemented. The biggest changes, including the new food good manufacturing practice, hazard analysis, Risk-Based Preventative Control rule and the Foreign Supplier Verification Program rule, will roll out in phases starting in September 2016 for the largest manufacturers. With the implementation of FSMA, FDA has taken a collaborative “educate, then regulate” approach by providing significant resources and engagement opportunities before the major rules roll out. AHPA is hopeful this collaborative approach is one that FDA will carry forward the implementation and enforcement of rules agency-wide.
Prochnow: While I think companies have had to make some changes with the enactment of FSMA, I think the new manufacturing practices being implemented in 21 CFR 117 are going to have a greater affect than any previous regulations enacted pursuant to FSMA. While FSMA gave the FDA more latitude to initiate mandatory recalls, such powers have been used very sparingly.
NIE: While the FSMA (Public Law 111-353) does provide some improved food-safety system measures, some believe that its over-reliance on recordkeeping and documentation that features a hazard analysis and critical control point (HACCP) algorithmic/risk-based approach to food safety, and an under-reliance on on-site physical inspections, does little to address the core problems in this country’s food-safety system: filthy factory farms and abysmal slaughterhouses. Agree/disagree? Why?
Fabricant: Yes, I agree somewhat. It can be viewed as a paper shuffle. I think that will address some compliance issues, but not all. I think you need to have a balanced approach with actual boots on the ground, as they say in the military. FDA inspectors looking at ingredient supplier facilities rather than looking at record keeping is critical. We need to know how they will enforce and hold ingredient suppliers accountable.
NIE: Does FSMA saddle raw material suppliers with an overly complex and expensive system of paperwork and systems, and onerous requirements? Yes/no? Please explain. Fabricant: I can’t say that it is all is unnecessary. There are certain aspects of FSMA, which have merit and have served fish HACCPs well over the years. If FDA has hope of evaluating safety, then I think inspections are the way to go.
MacKay: In principal, we know some companies have expressed concerns that there’s unnecessary and burdensome paperwork that does not directly transfer to a safer food supply required by FSMA. But the fact is, it’s too soon to see if that’s true, because we’ve yet to see how FDA will enforce that section of the law. We really appreciated when former FDA commissioner Dr. Mark McClellan publicly pronounced at a press conference about ephedra that FDA should not be claiming that DSHEA (Dietary Supplement Health and Education Act of 1994) didn’t work, at least until they had tried to make it work. We feel the same way in this situation. In principal, FSMA is well designed, and we need to see it in practice before we determine it’s too cumbersome. What we hope we’ll find is that it properly balances ensuring safe food with new record keeping requirements.
NIE: Does FSMA expose legitimate manufacturers (and classes of products) to baseless allegations of adulteration, contamination and misbranding?
Fabricant: No because I think manufacturers have GMPs to focus on. I think FSMA shifts the burden of raw ingredients to the manufacturer more than it should. We spent years exempting dietary ingredient suppliers from the final rule for dietary supplement cGMPs. You could argue FDA was creating a clear line of demarcation as to who was responsible for what. I think that same wall should be applied in FSMA. Suppliers of dietary ingredients, which have been the subject of much controversy for the industry, need to step up to the plate and shoulder the regulatory burden if they are responsible companies. I don’t see any companies like that creating industry-setting standards like NPA did in the mid-90s when cGMPs were discussed in those early days before there was even a regulation. I think you will see large retailers stepping up to demand that those types of quality systems are in place.
NIE: What was the FSMA’s end result regarding raw milk cheeses?
Fabricant: FDA was testing cheese samples for non-toxigenic E. coli because the thinking was that above a certain level, these bacteria could indicate unsanitary conditions in a processing plant. However, FDA’s surveillance sampling has shown that the vast majority of domestic and imported raw milk cheeses were meeting established criteria. FDA is still going to inspect cheese-making facilities and test for pathogens but they are punting on testing for non-toxigenic E. coli in cheese because their collected data thus far has turned up nothing.
NIE: According to Section 423 of the FSMA, if there is a “reasonable probability” that an article of food is adulterated under section 402 or misbranded under section 403, the FDA will offer the manufacturer an “opportunity to cease distribution and recall such article.”
The FDA has often called products misbranded based on the flimsiest of bases; it has also challenged the GRAS (generally recognized as safe) status of certain ingredients (or the data behind NDI [new dietary ingredient] filings) as arguably a back-door attempt to go after certain combination supplements. For example, the FDA has also made clear its regulatory animus regarding raw milk products (milk, cheeses).
Could the FDA attempt to use its expanded recall authority to effectively go on a “witch hunt” against certain products or classes of products that it cannot hurt through existing law?
Fabricant: I think it will use mandatory recall authority on products with a serious safety concern. It has not used 402(f)(1)(B) when a company has failed to file an NDI notification. Instead, they will look for cases, which if challenged in court, they will prevail. Therefore, they will choose cases where there is a safety concern and the company has failed to file an NDI notification. Safety concern may not be only serious adverse event reports in the CFSAN Adverse Events Reporting System (CAERS). It may be a plausible mechanism of action the agency has a concern about. It might be lack of scientific studies in the public domain to assure them there is no safety concern. So if you haven’t filed and you don’t have any basis as to whether the ingredient is safe for human consumption, those are cases the Agency could take a second look at. NDI warning letters are also less resource intensive than GMP warning letters. You may see the agency use 402(f)(1)(B) more in the future as resources, reduced by FSMA and part 111 GMP inspections, become scarce.
Prochnow: The FDA’s expanded mandatory recall authority is pursuant to Section 423 of the Federal Food, Drug and Cosmetic Act, which was facilitated by the FSMA. 21 USC 350i indicates that the FDA only has mandatory recall for intentionally adulterated food that could cause serious adverse health consequences or death to humans or animals. So, the recall authority is still only when there are serious safety issues. In the five years that it has had this expanded authority, it has used it very infrequently.
NIE: In Section 113 of the FSMA, there is a proviso to notify the U.S. Drug Enforcement Administration (DEA) if dietary supplements contain anabolic steroids, which could be excellent if judiciously applied.
The FDA merely needs to suspect that a supplement “may contain” an anabolic steroid or anabolic steroid analogue in order to refer a dietary supplement for DEA enforcement, so doesn’t this open the door to potential targeting of legitimate manufacturers along with the fly-by-night operators?
Fabricant: FDA will always target the weight-loss and bodybuilding class of products. That is just an expectation based upon FDA’s level of success in finding bad actors not listed on the label or drugs masquerading as dietary supplements. For FDA to take a product to task, they must test for the presence of that steroid. They won’t take action based upon a whim or that it even made a claim to contain it. DEA is now doing temporary scheduling to keep up with novel ingredients that they have never seen before. It is definitely one area where the synthetic chemists are staying ahead of the analytical chemists, and that is what makes this area a challenge to regulators.
Responsible companies in this space tend to be members of trade organizations like ours because they are doing the right thing from a compliance standpoint. Their doors are always open for inspections. You know they can be found at the address listed on their products. The bad actors tend not to want to be found. They have addresses, which point to USPS (U.S. Postal Service) shipping stores or post offices, or the listed address on the product is not legitimate. You can also look at the claims. If the claims are unbelievable and too good to be true, you might deal with anabolic steroid ingredients and fly-by-night operators. Fly-by-night companies tend to live for the here and now and are not built for the long haul.
MacKay: A product adulterated with an anabolic steroid or steroid analogue is a significant public health threat. As an industry we must embrace any efforts to keep young athletes away from these dangerous products. We’d urge the industry to stop being so suspicious of FDA’s motives. We’re in a new era, and we’re moving from being a young industry to a more mature industry and with that comes more responsibility to accept regulation and to help the agency weed out those products or companies that could potentially stunt the growth of the responsible industry. This is why CRN supported DASCA (Designer Anabolic Steroid Control Act of 2014), the law that provides FDA and DEA the ability to remove products adulterated with steroids from the market swiftly and efficiently. We have to trust the intent of the law and the agency’s mandate to protect consumers through that law. Anabolic steroids are drugs, not dietary supplements. Legitimate manufacturers understand that.
McGuffin: In 2014, the industry trade associations stood together in support of the Designer Anabolic Steroid Control Act that gave DEA the means and authority to aggressively prosecute those who sell anabolic steroids and their analogs as dietary supplements. FDA and DEA should use their full authority to stop the sale of these misbranded drugs and FSMA’s Section 113 mandates the interagency communication necessary to make that happen.
NIE: In Section 404 of an early version of the FSMA, it stipulates that “Nothing in this act (or an amendment made by this act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization (WTO) or any other treaty or international agreement to which the U.S. is a party (e.g., General Agreement on Tariffs and Trade [GATT], NAFTA [North American Free Trade Agreement], the Uruguay Rounds, Codex).” Isn’t this dangerous ground even if it was intended as a pro forma throwaway?
As an example of unintended consequences of nations including such language, one commentator claims that in Canada’s new Bill C-36, Health Canada has proposed that the powers provided to Parliament should be forfeited so that Canada can “honor its international agreements and commitments.”
Did this make it into the final version of the law? If so, has the FDA provided any explanation as to why sovereign U.S. domestic laws and regulations would need to be consistent, or not inconsistent, with international treaties and agreements?
Fabricant: This comes up from time to time. FDA always holds the position that its laws are sovereign. While other countries have unique categories for foods, U.S. law is unique in our category of foods like dietary supplements. It definitely makes exporting and importing a challenge to our industry. Some countries accept certain certificates of export and others do not. Some countries don’t even know what they want from the U.S. in terms of certification. I think they are looking for harmonization, but I don’t see that happening any time soon.
NIE: Section 420 of the FSMA states: “In the interest of national security, the Secretary of HHS, in consultation with the Secretary of Homeland Security, may determine the time, manner and form in which the guidance documents […] are made public, including by releasing such documents to targeted audiences.”
If the U.S. government does not care to release the very instructions and guidance needed by suppliers and producers in order to properly comply with the requirements, the government does not have to, if covered by the catch-all blanket of “national security.”
Isn’t it true that in this way many food producers would likely fail if the requirements (and related compliance guidance) were a secret until inspection?
Fabricant: I think in some ways it sets companies up to fail. However, FDA has released final rules and guidance. What we don’t know is when inspections will commence and how FDA will enforce that law. FDA has typically released guidance after formal rulemaking to help stakeholders, but they are also not in the business of providing much in the way of training and guidance. FDA does not offer cGMP training for part 111. It enforces the law. I think there will be growing pains with the first few years of implementing FSMA once a plan is in place, but that is to be expected. It is something new for companies to deal with and they many have not grasped their responsibilities under that law until proper guidance has been provided to stakeholders.
NIE: What specific steps should the natural products industry take, over and above regulations, to provide enhanced safety and increased consumer confidence as to dietary supplements and functional foods/beverages?
Fabricant: NPA is at the forefront on these issues. We were the first trade to develop a third-party certification program for dietary supplement good manufacturing practices. We are working with retailers and suppliers on many of these issues in light of FSMA. NPA also urges companies to seek third party certification for dietary supplement GMPs. FDA just released finalized guidance on medical foods, which in a way parallels functional foods as a category of food in other countries. NPA sees a greater need for medical foods and for FDA to expand what it consider as medical foods. Nutrition is an important consideration to manage some disease.
MacKay: The dietary supplement industry should be focusing on industry accountability. First, and foremost, all companies should be following the laws, whether it’s ensuring compliance with good manufacturing practices or submitting NDI notifications as required by law. CRN has announced all of our finished product manufacturers will be required to submit product labels to the ODS (operational data store) database, and we’ve just announced an industry-wide product registry. These are first steps toward providing increased transparency for researchers, regulators and retailers to better understand what’s in the market. Eventually we hope the registry will also benefit consumers by helping them evaluate product choices. We have to ask ourselves—what’s the right thing to do for our consumers. And then do it. Manufacturing safe, high quality beneficial products that will help our consumers live healthier lives—that’s what will keep our industry growing.
McGuffin: Natural products marketers and consumers have often been ahead of both legislators and regulators when it comes to setting product expectations.
While we will always appreciate the leadership of our Congressional allies in crafting the DSHEA in 1994, it was consumer demand for access to herbs and other supplements that led to this Congressional action. In other words, DSHEA did not create the supplement market—supplement consumers created DSHEA.
Similarly, in 2006 a broad coalition of industry trade associations and consumer groups led the Congress to pass the Dietary Supplement and Nonprescription Drug Consumer Protection Act, thereby creating a new requirement for supplement marketers to submit all serious adverse event reports received in association with their products, and again enhancing product safety.
Existing regulations can currently be viewed as completely adequate to ensure that all supplement products and their ingredients are safe. If this view changes, recent history suggests the industry will once again lead the way to better regulations.
Prochnow: I think it is important for the industry, internally, to address companies clearly operating in violation of the law. Whether it is a trade organization refusing membership, companies reporting egregious violators to the FDA, or taking action through a number of different channels, weeding out the clear bad actors sends a message that the industry isn’t going to tolerate companies operating outside the law. Individually, companies should be doing more frequent testing of label claims to ensure they are meeting the claims made on the labels, so that consumers can confidently expect they are getting what they think they are buying.
Tips: One part of the industry is ignoring the new food-safety measures and simply continuing to do “business as normal,” hoping that they won’t get caught or that when they do that it will result in a relatively painless slap-on-the-wrist punishment. Given FDA’s stretched-to-capacity situation, many of these companies actually will coast along under the radar for many years.
However, the more responsible companies are implementing measures to comply with government food-safety regulations.
But what I see as the more important trend in food safety here is that some trade organizations have adopted their own food safety certification programs that their members either must adopt or may adopt. The real future of food safety does not lie in coercive governmental dictates, which are always subject to political vagaries and corruption, but lies in voluntary industry standards and practices backed by strong certification programs that will assure consumers that the products they are buying are safe and healthful. NIE