Supplement manufacturers need to embrace clear traceability procedures to ensure that only high-quality supplements enter the market in order to reduce risk to consumers. Consider, for instance, a March 2013 U.S. Government Accountability Office report noting that over the period of 2008-2011, FDA received 6,307 adverse-event reports related to dietary supplements.1 While the reasons for these reports vary, it is a good reminder of why quality control— and, by association, traceability—is always important. The need for traceability is also great given a current worldwide rise in allergies. Just in the U.S., for example, in 2012, 9.0% of U.S. children and 7% of U.S. adults were reported as having hay fever.2 It’s clear that growth in supplement consumption must be paired with a growth in traceability from the dietary supplement industry. Even one mistake can have serious consequences.
Luckily, there are clear rules and legislation, depending on the region in which production is located, that producers can follow to ensure that they are maintaining high standards when it comes to supplement production. At the same time, there are many innovative technologies available that can help businesses not only improve traceability but also save money and improve process efficiency.
Legislation in the U.S. and EU
In the U.S., the regulation of food and dietary supplements comes under the remit of the Food and Drug Administration (FDA). Food products in the U.S. are subdivided into various categories, including foods, food additives, added substances, and dietary supplements, with specific manufacturing standards differing between the categories. Dietary supplement production must comply with the current good manufacturing practices for dietary supplements (cGMP) established in 2007.
Dietary supplements are complex products, and the FDA’s cGMPs for dietary supplements help ensure composition, purity, and strength. The cGMPs set out requirements for manufacturers to produce, hold, and distribute dietary supplements, as well as the materials used to manufacture them, under appropriate conditions so that the quality of the dietary supplement is not affected.
Meanwhile, the European Union’s (EU) Food Supplements Directive of 2002 requires that supplements be proven to be safe, both in dosage and in purity. Supplements must first be confirmed to be safe before they are sold in the EU without a prescription. In the category of food, however, the regulations regarding traceability and good manufacturing practices are governed by each member state’s internal regulations and come under the remit of internal regulators.
For example, in the UK supplement production is governed by the Food Standards Authority, which requires food producers and distributers be able, as a minimum, to trace products one step in both direction along the supply chain. It also requires all dietary supplement suppliers to register as a food business operator (FBO) and follow specific legislation.
To this extent, it is good practice for dietary supplement producers to trace every single ingredient throughout the whole of their supply chain. Not only will this have good business applications, because fully understanding a supply chain will drastically reduce the cost of a recall, but problematic steps or points of contamination will become easier to trace, cutting down the number of products that need to be recalled should the worst happen.
Technology for Traceability
FDA’s cGMPs require manufacturers to maintain a written record of traceability. However, written records are time-consuming to produce and prone to error because workers will only ever be able to record a snapshot of conditions instead of being able to see and record the entire overview.
However, technologies such as manufacturing operations management (MOM) systems now allow producers to record this data and achieve deeper understanding of their product automatically. MOM systems record data from sensors, which allows producers to create digital passports for products that run through the production plant.
The Benefits of MOM Systems
MOM systems allows manufacturers to break down a production plant into distinct steps that are recorded into a product’s digital passport. This means that plant managers can easily track the precise conditions of the product through the production process and, for example, identify when and where a contaminant or potential contaminant has entered the system.
Producers that use MOM systems can, therefore, state exactly what is in their product, confirm that the product has been maintained at safe conditions, and, in the case of contamination, plant managers can accurately understand how many batches need recalling. This will increase the transparency of business operations and build a relationship of trust with consumers and buyers.
As more people begin to take supplements as a part of their daily diet, it is imperative that manufacturers continue to improve traceability. Only when there is a clear line of traceability will producers be able to create a strong and stable bridge of trust with consumers.
Darcy Simonis is food and beverage group vice president at ABB (Zurich, Switzerland). ABB (ABBN: SIX Swiss Ex) is a pioneering technology leader with a comprehensive offering for digital industries, with four customer-focused, globally leading businesses: electrification, industrial automation, motion, and robotics & discrete automation, supported by its common ABB Ability digital platform. ABB’s Power Grids business will be divested to Hitachi in 2020. ABB operates in more than 100 countries with about 147,000 employees.
- U.S. Government Accountability Office report. “Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products.” March 2013. Accessed at: https://www.gao.gov/assets/660/653113.pdf
- American Academy of Allergy Asthma and Immunology website. “Allergy Statistics.” Accessed at: https://www.aaaai.org/about-aaaai/newsroom/allergy-statistics