Preventative Allergen Controls: How are manufacturers handling the requirements?

Effective January 1st,2023 sesame will be added as the 9th major food allergen required to be labeled on packaging and monitored within manufacturing facilities under the regulations of FSMA and the FASTER Act. 

Around 18 years ago, FALCPA determined that there were 8 major allergens that elicit the majority reactions for most consumers. To better serve the customers, the FDA mandated that manufacturers of consumer goods monitor label these 8 allergens and provide clear warnings.  Over the years both manufacturing companies and the FDA have provided statements to address cross-contact and labeling warning statements.  Most often the use of “may contains” statements or “processed in a facility which…” statements were used to notify that an allergen was present in the facility/line and the company was aware that their products may not be 100% allergen free of the stated allergens.  The FDA has been very clear since these statements gained popularity that labeling statements are not to be used instead of good manufacturing practices when it comes to allergen control, they are adamant that the manufacturer must provide the best possible efforts to avoid allergen cross-contact, first. After all other means have been addressed then additional warning steps can be utilized. 

On April 23rd, 2022, the Food Allergy Safety, Treatment, Education, and Research Act (FASTER) was signed into law.  The intent of this law was to follow the stringency of the newly recognized laws in FSMA and further provide protection for consumers before, during, and after manufacturing.  FSMA put allergen cross-contact at the same level of concern as microbial contamination and the FASTER Act reinforced the need for preventative sanitation controls and allergen awareness. Clean the lines, which will protect consumers. The FASTER Act also added a 9th allergen (sesame) to the list of major allergens currently mandated by the FDA.  On the 1st of the new year allergen labeling for sesame will be required on packaging, which also means the allergen will fall under the stringency of FSMA. 

Manufacturers do not have to remove products already in commerce, but after January 1st all new food will be mandated.  Some major companies have already prepared for this change and some of the strategies have sparked controversy. Namely, companies are adding trace amounts of allergenic ingredients (sesame) to all formulations to avoid having to do allergen changeover cleaning.  Some consumers feel that this defeats the purpose of the FASTER Act, many people who suffer from food allergies trust companies who have products which contain an allergen such as sesame and also produce products that do not contain the allergen, now however the companies are adding trace amounts of sesame to all products to avoid mandatory changeover cleaning.  The companies are explaining that the facility is either not equipped to handle the constant changeover or avoid cross-contact thoroughly enough.  The FDA requires that an allergen is listed in the product if listed in the allergen statement, so the trace amounts are added to adhere to the regulations.

Are companies skirting the regulations or are they being transparent in their labeling? Many critics are arguing the latter.  Stating that due diligence is not being done to assure safe food and a band-aid approach will not benefit the consumer.