In today’s world, companies are always searching for the latest and greatest products to bring to our customers. Creating something new can be exciting and profitable for your business, but there are a lot of things that you, as the food safety manager, need to consider. As with all things, there are multiple regulatory hurdles in creating a new product. In this column, I want to review some of the major ones of which you need to be aware, so that your company can legally and safely produce new products.
As I have discussed in my last few columns, you need to make sure your R&D and production personnel are communicating with you. If a USDA inspector walks on the floor and sees you making something new that you haven’t addressed, you have big problems. So continue to remind all of your management that even if they don’t think it needs to, everything new must go through the food safety group for review.
Often, others don’t realize everything that goes into making new products. Make sure they understand that it takes time to get approval, sometimes from multiple agencies, before the product can be produced. The major hurdles with creating something new are:
- Sample vs. experimental
Sample vs. Experimental.
I know you won’t be surprised when I tell you there is a specific regulation regarding the difference between sample and experimental product. The reason behind this is that if you make something new to “test” and you put the mark of inspection on it, then it is now considered a “legal” product and must be addressed in your HACCP and all related food safety programs. FSIS Directive 7000.2 clearly explains the difference:
- Experimental products: Products that are produced for research and development and not offered for sale. Experimental products are new products or existing products that introduce a new formulation or flavor. These products may be prepared and taste tested in such facilities as test kitchens, sensory panel rooms, research and development facilities within a corporate organization, and inspected or non-inspected areas within an establishment. While still under the control of the company, these products may be made available to test panels or company employees that will judge the quality and appeal of the new product. The panels may meet within the establishment’s facilities, sensory panel rooms, or under contracted conditions, such as at an independent evaluator’s location where the company retains control of the product.
- Sample products: Products that are made available for pre-market consumer testing and available to the general public and not for sale. In such cases, the company relinquishes control of the product by its distribution to those outside the employ of the company.
So in plain terms, if you make a “new” product and it leaves your control, it is considered sample product, and all regulations are applicable. Once you put the USDA “bug” on the bag or the box, it is considered a “legal” product. Make sure you are clear on how you are handling the testing of your new product before you proceed.
Labeling products is always a difficult task. There are many questions you need to ask yourself. Are you making claims? What are the ingredients? Do you need nutritional labeling? USDA regulations now allow for “sketch” labeling (meaning you can make the label without approval) if the product does not make special claims such as “fat-free,” “Angus,” etc. There are four situations for which labeling approval is required by USDA. They are:
- Labels for temporary approval (9 CFR 412.1(c)(4)).
- Labels for products produced under religious exemption (9 CFR 412.1(c)(1)).
- Labels for products for export with labeling deviations (9 CFR 412.1(c)(2)).
- Labels with special statements and claims (9 CFR 412.1(c)(3)).
Be aware that if you are dealing with cattle and claims as to how it is raised or its genotype, then you are also required to go through the ARC/AMS branch of USDA for additional certification requirements.
Obviously, you would want to know if this new product has ingredients that are considered one of the seven major allergens. As you know, you would then need supplier approval, label review, and everything you would normally do with allergens.
Probably the biggest mistake I see is that new products are not addressed adequately in HACCP. Again, make sure you know what your production people are doing. More than once I have heard stories of USDA inspection personnel walking onto the floor, seeing a new chemical, process, or ingredient being used (even if it’s for sample purposes as previously discussed), and then looking at the HACCP plan to see that it’s not addressed and you were not told about it. This can quickly turn into a recall situation. Heaven help you if USDA walks onto your production floor and finds that a new ingredient is being tried in some dark corner that has an allergen in it. If you didn’t address it in your HACCP plan, saying “Oh don’t worry, it’s only to test something new,” you will lose.
Make sure you are aware of all applicable regulations regarding this new product. Is it intact or non-intact? Again, does it include allergens? What are the labeling regulations?
Creating new products can be an exciting and profitable time for your business. Just make sure you’re a step ahead or you’re already a step behind.