Most adults in the United States frequently take one or more dietary supplement every day. With a growing number of users, it is imperative that more must be done to ensure product fidelity and consumers are protected. Here Darcy Simonis, Industry network leader at ABB food and beverage, explains how to improve traceability in dietary supplement production.
Though many dietary supplements contain naturally occurring ingredients, the industry has not been without scandal. Over the period of 2008 to 2011, the Government Accountability Office of the United States received 6,307 reports of health problems from the consumption of dietary supplements. Subsequent testing of herbal dietary supplements found that 80 per cent of tested products in fact contained chemical contaminants.
Pairing this with the current worldwide rise in allergies, where seven per cent of children have been diagnosed with allergies, compared to just three per cent of the adult population paints a worrying picture, it’s clear that the growth in supplement consumption must be paired with a growth in traceability from the dietary supplement industry.
Supplements manufacturers need to embrace clear traceability procedures to ensure that only high-quality supplements enter the market. Especially as the risk to consumers is high — even one mistake can cause long lasting and potentially fatal consequences.
Luckily there are clear rules and legislation that producers can follow to ensure that they are maintaining high standards when it comes to supplement production, depending on the region in which production is located. 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 USA and EU
In the USA, the regulation of food and dietary supplements comes under the remit of the Food and Drug Administration (FDA). Food products in the USA are subdivided into various categories, including foods, food additives, added substances and dietary supplements, with specific standards differing between the categories. Under these regulations dietary supplement production must comply with the good manufacturing practices (GMP) established in 2007.
Dietary supplements are complex products and the FDA’s GMPs for dietary supplements help ensure composition, purity and strength. The GMPs 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 dosages and in purity. Supplements must also first be confirmed to be safe before they are sold in the EU without a prescription. As a category of food, however, the regulations regarding traceability and good manufacturing practices are governed by each member states 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 product 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
The FDA’s GMPs require a written record of traceability to be maintained. However, this is time consuming and prone to errors 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 operation 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.
For example, ABB’s MOM system allows manufacturers to break down a production plant into distinct steps that are recorded into the products 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 contaminate or potential contaminant has entered the system.
Producers that use MOM systems can, therefore, state exactly what is in their product, confirm that it 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 diets 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.