The issue of food safety has affected many aspects of the natural products industry.
Nutrition Industry Executive (NIE) magazine asked those schooled on the subject to discuss this topic, and offer their thoughts on what the industry can do to make safe products, comply with government regulations and gain the confidence of consumers.
The participants are:
• Stan Hazan
Senior Director of Regulatory Affairs and Associate Programs
Ann Arbor, MI
• Jim Bail
Food Safety Consulting Director
Ann Arbor, MI
Chief Operating Officer
American Key Food Products
CEO & President
Long Beach, CA
• Margaret Lawson
Vice President, Regulatory & Scientific Affairs Liaison
• Jen Johansen
Vice President of Quality & Regulatory Affairs
NIE: What effect has the Food Safety Modernization Act (FSMA) made on the natural products the industry?
Hazan:The Food Safety Modernization is having a profound effect on the food industry. The proposed rules have injected a new level of urgency regarding regulatory compliance and the changes required to comply. Significant questions remain regarding what the FDA (U.S. Food and Drug Administration) expects and how they will interpret the new good manufacturing practices (GMPs). Demand for training and consulting services has increased exponentially since FSMA was signed into law as companies scramble to understand and prepare for FSMA implementation, as well as to improve food safety management systems. For many larger companies, the changes required by FSMA are minimal, especially for those firms that have obtained GFSI (Global Food Safety Initiative) certifications, whereas smaller and foreign food producers will likely require more extensive change.
Pontiakos:In 2011, the U.S. passed the most extensive reform of its food safety laws in over 70 years: The Food Safety Modernization Act. This established preventive measures, rather than the previous reactive measures, against food adulteration and contamination. However, FSMA has seen a very gradual implementation. The FDA has yet to release most of its regulations. It took them over a year to establish the revised GMPs and they are just now becoming more stringent on enforcing them. This recent crackdown has already caused finished product manufacturers to enhance their manufacturing, testing, and most significantly documentation procedures. Although the industry has already felt the impact of FSMA, we are closing in on a time when we will feel it in its entirety—hopefully within the next few years.
Lawson:FSMA is still in the comment period and not finalized, therefore all is subject to change. FSMA is anticipated to bring huge changes especially with scrutiny and compliance through the supply chain. Record keeping and oversight of foreign suppliers will be critical. The world of brokers, distributors and importers will change as customers will need to know which plant location they are receiving ingredients from.
GMA (Grocery Manufacturers Association) and FDA have a strong, positive working relationship with regard to FSMA to help ensure the Act is reasonable to ensure safety without tremendous cost to the industry.
Johansen:In addition to re-registration, inclusion of intentional adulteration in your company food safety plans, and maintaining internal lists of your foreign suppliers I believe that FSMA is influencing FDA inspections toward an increased scrutiny of agriculture practices.
NIE: What is the industry doing to ensure that products are being made safely?
Hazan: Herbal/dietary supplement products are most impacted by the dietary supplement GMPs under 12 CFR 111, which have been in place since 2010 and that industry is well on its way toward full compliance with these GMPs.
Festo: More companies are aligning with the orientation and standards adopted by the Global Food Safety Initiative (GSFI), which looks at food safety throughout the entire food supply chain. This trend is gaining traction even with smaller-sized food companies as consumers themselves are sensitized to food safety and health considerations.
Pontiakos: The industry, as a whole, is taking steps to ensure that products are made safely; the exact step depends on the role of the organization—ingredient supplier, finished product manufacturer, contract manufacturer, industry association, etc. For example, industry associations provide updates on regulations and how to alter processes and procedures to adhere to them while finished product manufacturers implement those changes. Since adulteration and contamination can occur at any point in the supply chain every step is equally crucial, not one more than the other. We, as an industry, understand that providing safe product is both an individual and team effort—each organization must do their own part to build a quality supply chain. One bad link disrupts the whole chain.
Lawson: Ethical suppliers follow GMP with robust quality programs regarding safety and food defense. Traceability is critical to know where ingredients are sourced along with each manufacturer doing their due diligence with auditing their suppliers. Purchasing from a principled supplier is a critical step in a quality program.
Johansen: Companies are asking for proof through appropriate testing to support documented claims and specifications. Industry is also conducting on-site facility inspections of their suppliers and contract manufactures, and approaching business relationships as partnerships with clear GMP and quality agreements in place. Industry is driving an increase in transparency through the entire farm to fork (or farm to tablet) supply chain.
NIE: What type of ingredients and/or products are at risk and why?
Hazan: Any food product or ingredient that is not grown, harvested, processed, packaged or transported according to good manufacturing practices should be considered high risk. Those products that are consumed raw, such as many categories of fruits and vegetables, require extra vigilance by those in the supply chain because there is no “kill step” to eliminate pathogens. The FDA has published risk categorization criteria that producers can use to determine the risk profile of the food they importing, processing, packing, retailing, etc. The new FSMA rules require preventative measures to mitigate these high-risk commodities. Protein (meat, shelled eggs, etc.) is another high-risk category in terms of food borne pathogens. However, these commodities are not directly affected by FSMA because they continue to be regulated by USDA (U.S. Department of Agriculture). However, these food categories already require HACCP (Hazard Analysis and Critical Control Points) plans to identify and manage risks.
Festo: American food companies are specially concerned with the safety and quality of ingredients and/or products that are sourced from overseas, particularly less developed countries. The adoption of tight safety and quality standards here are met with hesitation by foreign suppliers and manufacturers for a variety of reasons. The most common obstacle is the lack of information infrastructure that will allow the primary raw material suppliers to be aware of all informational and documentary requirements that are needed by the end-users in the U.S. Most rural farmers in developing countries engage in farming using conventional practices that do not entail a detailed inspection of the composition of farm inputs (e.g., pesticides and fertilizers). Farm to market (processors) infrastructure are not as highly developed as in the U.S.; nor are the modes of shipping or transport. While importers and distributors of imported products exercise diligence in vetting foreign suppliers, it is a difficult if not impossible task of ensuring complete and timely documentation every time.
Foreign suppliers also frown on quickly adopting quality and safety assurance practices prescribed by most current standards since these almost always entail additional capital and operating expenditures. These increments necessarily lead to cost increases. On the other hand, buyers/importers do not readily accept price adjustments and still want to buy cheap. The resulting squeeze on foreign suppliers thus hampers the transition to current standards.
Pontiakos: All ingredients are at risk for adulteration and contamination, it is just some more than others. Botanical ingredients are principally more multifarious than other ingredients. A botanical can vary in many manners depending on the plant part, the growing regions, etc., making monitoring and testing especially important compared to other ingredients.
Other ingredients that are especially susceptible to adulteration and contamination are “fad” ingredients, such as green coffee bean extract. With just one feature on “The Dr. Oz Show,” retailers have seen product purchases jump significantly due to an ingredient’s overnight success. As with any overnight success story, the sudden and significant spike in demand can disrupt and strip the supply chain—those already supplying the product scramble to secure additional material while those who are not already supplying the product scramble to get caught up. Because of this demand, the quality of the product is jeopardized. In this type of urgency, it is more difficult for finished product manufacturers to recognize an adulterated ingredient; unscrupulous companies will take advantage of this. The industry has already witnessed this in the months following Dr. Oz’s green coffee bean promotion. Several suppliers have been caught claiming more chlorogenic acid—the component in green coffee bean that aids in weight loss—than what is actually in their material while other suppliers have been caught supplying impure green coffee bean extract.
Lawson: At risk ingredients are those purchased without knowing the source and quality programs at the manufacturing site. It is important to monitor climate and political situations where ingredients are sourced to identify potential “at risk” ingredients for adulteration during short supplies.
Johansen: Deliberate adulteration of products masquerading as dietary supplements in the bodybuilding and weight-loss category pose a risk to products that are actually real and legal.
NIE: Have GMOs (genetically modified organisms) affected food safety in regard to supplements?
Hazan: The relatively recent development of GMOs in the supply chain has not resulted in significant new food safety risks resulting from pathogens. However, as consumers continue to demand and purchase food that is free of GMOs, hormones, pesticides, antibiotics, etc., some suppliers have had to adjust by finding new sources and suppliers.
Pontiakos: In the natural product industry, the non-GMO segment is proving to be the fastest growing with over $3.5 billion in sales. There is no denying that in order to take advantage of this growing market, supplement manufacturers need to transition some or all of their products to non-GMO—a good amount of companies have already done so through the Non-GMO Project Verified label. This verification is not an easy achievement—it requires a lot of documentation and traceability, forcing supplement manufacturers to put in their due diligence.
Transitioning to non-GMO may not just be an advantage in a couple of years; it may be a requirement to keep up with the market. Recently, Whole Foods announced they plan to achieve full GMO transparency by 2018, requiring all GMO products to be labeled. If other retailers follow suit, non-GMO may become the standard.
Johansen: Some of the components unique to the dietary supplement delivery systems or product types pose challenges in the GMO arena. For instance corn derived sorbitol and maltodextrin are near impossible to find a GMO-free supply of. And the gelatin in gel caps must come from cattle that eat only GMO-free feed.
NIE: What have industry groups and associations done to address the issue?
Hazan: Practically every industry group and trade association has made FSMA a high priority for their members through training and education via webinars and seminars, and by making room on their annual conference program for FSMA-related topics. Many associations have submitted comments on the proposed rules to ensure that the final rules reflect the realities of their industries.
Festo: Industry groups and associations vigorously lobby against adoption of new legislation or regulations that will adversely impact the current status of GMO ingredients/products
Pontiakos: The topic of GMO labeling has just recently come into the public spotlight in the last few years and only a few weeks ago the first ever GMO labeling legislation passed without the caveat that other states must pass similar laws, but only for foods. With the novelty of the subject matter, most in the industry are not entirely aware or ready of what exactly GMO labeling would entail. Industry groups and associations – many of which helped with the GMO labeling proposals – are facilitating the understanding of them through educational material, seminars, webinars, and much more. For instance, last year the United Natural Products Alliance hosted a seminar entitled “The Non-GMO Future: How to Source, Test, Label, and Mark Food and Supplement Ingredients.”
Johansen:There is a great deal of education and learning about the supply chain that is occurring through the Non-GMO Project’s verification program.
NIE: What are suppliers and manufacturers doing to address the issue of food safety? What are their biggest challenges in this area?
Hazan: Manufacturers and retailers are trying to understand what an FSMA-compliant food safety plan is, how it differs from what they may already be doing such as HACCP plans, and identifying the changes needed to be in alignment with the new regulations. The biggest challenges are probably the implementation of the new food safety plans, and the process and documentation changes needed.
Festo: To ensure the production of quality, safe products, manufacturers need to invest not just in improved facilities but also in organizations that are better oriented with the global supply environment. It is sometimes alarming to note that buyers and quality assurance management and staff are so naïve about the world outside the U.S. and assume that whatever can be done easily in a typical food company in the U.S. can actually an enormous challenge to a company in another part of the world.
Johansen: Suppliers and manufacturers are testing and obtaining a better understanding of the ingredients in their products (knowing clearly about the presence or absence of GMOs, gluten, and allergens for instance). Challenges in supply chain are still present with regards to ingredient change because of lack of supply or a desire to reduce costs. So, change control, communication and cooperative relationships with vendors are essential.
NIE: What kind of investment is needed by manufacturers to not only ensure, but produce a quality product?
Bail: The most meaningful investment is in training and orientation of your team—get to know the particulars of the rules that relate directly to your products and develop a plan to ensure compliance. This coincides with a specific FSMA requirement to have a “Qualified Individual” on staff that is responsible for developing and documenting a validated, effective and verifiable food safety plan. Significant time and effort will be required to do this, so be prepared to empower your food safety team to devote themselves to the effort.
It stands to reason that good food (quality) is safe food. With food safety as a starting point, developing a quality program comes naturally and many of the same principles can be effectively applied.
Pontiakos: As with any successful company, manufacturers must invest in these three things to produce a quality product:
- Capital Investment – Capital investment not only includes a multitude of manufacturing equipment, but also a laboratory fully equipped with the latest testing technologies.
- Human Investment – Human investment includes knowledgeable employees at every point of the organization—from the buyer who is capable of mentoring vendors to the quality department that consists of botanists, chemists, and microbiologists to the sales representative who can automatically distinguish if their client’s specifications are feasible. Not only do employees need to be knowledgeable in their trade, but they also need to understand and live by the quality policy of the company.
- Inventory Investment – In this industry, inventory investment basically means building a quality supplier base. Most, if not all, quality related questions can be answer by evaluating the cultivation and harvesting practices, the manufacturing practices, and the quality control program adopted by the suppliers.
Johansen: Investment in a company culture of compliance and quality is essential. Invest in training of your employees in food safety, GMPs and leadership. It’s the people making and handling your products that ultimately create and shape the quality.
NIE: How has food safety improved?
Bail: Customer expectations coupled with suppliers’ focus on continuous improvement have driven advances in food safety through higher levels of due diligence. The progressive embrace of global food safety standards by the industry has also resulted in a sharper focus on food safety by design as well as by execution in operations. Suppliers are developing a deeper knowledge risk assessment and management and effectively applying it to their operations.
Proclaiming the best testing methodology is impossible in a broad sense because it depends very much on the particular products in question, best applicable laboratory practices and regulatory requirements. Regulatory compliance is a given. From there, the choice of methodology should be based on the best available technology and demonstrable competence of the laboratory.
Food safety has improved from the standpoint that traceability is now a requirement that allows faster identification of ingredient and materials sources, and destination of finished products, in the event of a suspected outbreak or problem. The FDA also has new detention and recall authority and is able to quarantine product suspected of being contaminated or adulterated. The required complaints files and reportable food registry provides companies and regulators with the data needed to better identify potential problems. But most of all, food safety has improved because we are getting better at anticipating problems through hazard analysis and implementation of preventive controls.
Pontiakos: In the last few decades, we have seen the industry progress to what it is today—an industry with great growth potential, innovation, and increased focus on quality. Sourcing sophistication, crop models, organics cultivation and wildcrafting are mandatory skill sets and on one very important level, a barrier to entry for those who do not have the capital strength to invest in their business. Irradition, ETO and chemical treatment outlawed. Steam, heat, microwave, and peroxide sterilization refined. Testing methodologies have evolved in adulteration, chemical and microbiological testing.
However, one of the challenges the industry faces today is the lack of standardized methods. For example, different types of identification methods such as macroscopic, microscopic, organoleptic, TLC, HPTLC, HPLC, FTIR may be used to identify the genus, species and plant part. Each of these identity tests has advantages and limitations. Using different methodologies produces different test results. Therefore a product that may meet all the requirements using a certain method, may not meet the requirements using a different method. Several industry organizations are currently working toward standardization of processing and testing methodologies.
Johansen: There are excellent third party contract labs for microbial contaminant testing, for instance Silliker.