Margaret Lawson on Food Safety in the Natural Products Industry

07 August, 2014
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The following excerpts were taken from a round-table discussion, including DDW Chief Science Officer, Margaret Lawson, with Nutrition Industry Executive Magazine about food safety in the natural products industry. Read on to see some highlights from the discussion.

The participants were:

[one_half]Stan Hazan
Senior Director of Regulatory Affairs and Associate Programs
NSF International

Jim Bail
Food Safety Consulting Director
NSF International

Mel Festo
Chief Operating Officer
American Key Food Products[/one_half]

George Pontiakos
CEO & President
BI Nutraceuticals

Margaret Lawson
Vice President, Regulatory & Scientific Affairs Liaison
D.D. Williamson

Jen Johansen
Vice President of Quality & Regulatory Affairs
Nutrex Hawaii


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.

To find out more about food safety in the natural products industry, get the full article at

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