Tag Archives: manufacturing

Camila Gadotti, 3M
In the Food Lab

Examining the Role of Food Safety During R&D

By Camila Gadotti, M.S.
1 Comment
Camila Gadotti, 3M

Research and development (R&D) is an essential starting point toward the creation or modification of new and exciting food products, processes and packaging. To ensure that a product is safe for consumption, food safety should be considered during the initial stages of a product’s lifecycle. Incorporating food safety into R&D can be tricky, as safety considerations may change the initial idea or concept of a new food product. For example, the idea of a freshly squeezed orange juice in every supermarket shelf is appealing; however, without pasteurization, that juice will not be safe for consumption, nor will it have the desired shelf life. Adding raw chopped garlic to a hummus product makes it taste great, but will it be safe for consumption after being on the shelf for a month?

To better understand how safety of new products is assured from concept to launch, I spoke with two R&D scientists about food safety considerations during new product development. The interviewees, Maria and Laura, work for the same large food manufacturer, which is located in the Midwest, in the snack foods and breakfast cereals categories, respectively. They both confirm that the R&D team follows a specific procedure during the product concept phase—one that places food safety at the forefront. The team starts by determining how the new product compares to food safety regimens already in place with other products that the company manufactures. If the product is a line extension with only a few changes to an existing formulation, the food safety concerns are likely to be low, and the food safety program already in place is adapted to meet the safety needs of the new product. However, if the product being developed is highly differentiated from other products manufactured by the company, food safety moves into a more central role throughout the development cycle.

According to Maria and Laura, the first step in ensuring food safety for a new product is for the development scientists to have in-depth discussions about the product’s formulation, ingredients and supply sources. These three aspects, along with the planned manufacturing process, are then evaluated through a hazard assessment. The hazard assessment is comprised of microbiological, quality, regulatory, stability and physical hazard assessments. Ingredients that pose food safety concerns without prior controls and process conditions are identified. The quality team determines controls for these ingredients and subsequently involves process engineers to verify that process conditions are attainable and will provide proper control for the hazards identified. A complete HAACP plan is put in place for the new product production, taking into consideration equipment cleanability and location, traffic control for ingredients and operators, and air handling systems. The hazard assessment is documented in detail and must be approved by the quality manager before production runs can begin and development can resume. Although the entire process is led by R&D, multiple other functions are involved and consulted throughout the process.

Manufacturing processes, formulation and market availability of ingredients drive the food safety of a new product, with manufacturing processes and formulation usually being the key drivers. “However, in cases like the recent shortage of eggs due to the avian flu crisis, finding substitutions for ingredients in shortage becomes an important driver for food safety,” says Maria. Laura says that at times, product formulations can change due the integrity of the ingredient or its source. In such cases, a similar ingredient from a credible source is chosen and the safety of the product is re-assessed. There are critical quality and food safety elements that must be considered in the product design phase to prevent issues later in development. When R&D professionals keep these elements top-of-mind when considering formulation and ingredient sourcing, everyone benefits—from the company to consumers.

Although consumer confidence in the safety of the U.S. food supply is slipping (11% said they were “very confident” in the safety of the food supply, down from 15% in 2013; 50% said they were “somewhat confident”, down from 55% in 2013, according to the International Food Information Council’s 2015 Food and Health Survey), the interview with Maria and Laura shows that manufacturers are putting significant effort into developing safe food products. It is equally as important for suppliers and vendors to have robust food safety programs to build strong relationships with manufacturers. Food companies have a lot to lose if a product they develop is, or becomes, unsafe for consumption. Not only can the average cost of a recall add up to $10 million in direct costs to a food company, lost sales and the impact to the company’s market value, brand reputation, and business relationships is major. Some companies never recover from the punch. Through taking the time to audit suppliers, screen new ingredients, and make robust prototypes, food companies can be more confident in the safety of their innovative new products as they go through the development process.

hemp-infused tea

Hemp-Infused Beverages: FDA Compliance and the Cannabis Industry

By Aaron G. Biros
1 Comment
hemp-infused tea

With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.

“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.

hemp-infused tea
Lexaria’s ViPova black tea infused with CBD oil made from industrial hemp

A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.

Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.

Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.

Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.

“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”

Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.

“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”

Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.

Top 6 Best Practices for Your Allergen Control Program

Undeclared allergens are the cause of a great number of recalls in the United States, causing significant consumer health issues, scrap costs, and sourcing conundrums. Under FSMA, good manufacturing practices are undergoing revisions, and the one area that has gotten the most attention is allergen control.

Undeclared allergens were responsible for the greatest number of recalls in the United States in 2013, causing significant consumer health issues, scrap costs, and sourcing conundrums. Under the Food Safety Modernization Act (FSMA), good manufacturing practices (GMPs) are undergoing revisions — and the one area that has gotten the most attention is allergen control. Under the new GMPs, an emphasis has been put on facilities to have an allergen control program.

Further, 15 million Americans and 17 million Europeans have documented food allergies. According to a study released by the Centers for Disease Control and Prevention (CDC), food allergies have increased by 50 percent among children from 1997 to 2011; and hospital admissions for severe reactions have increased seven-fold in Europe over the past decade, according to the European Academy of Allergy and Clinical Immunology.

FSMA’s Proposed Rule for Preventive Controls for Human Food has two major features–provisions requiring hazard analysis and risk-based preventive controls, and revisions to the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110. Included within these revisions is the requirement that each covered facility prepare and implement a written food safety plan, which includes a hazard analysis, preventive controls (e.g., process controls, food allergen controls, sanitation controls, and recall plan), monitoring procedures, corrective actions, verification activities, and recordkeeping.

Allergen Control Programs are multifaceted with elements ranging from ingredient supplier verification, storage, scheduling, formula and rework control, sanitation and changeovers, and label verification.

In essence, there are two main goals of an allergen control program, which appear simple on paper, but are very difficult to execute.

  • Goal #1: If you make a product with an allergen in it, you need to make sure that the allergen is declared on the label.
  • Goal #2: If you make a product that is NOT supposed to have a specific allergen in it, you need to do everything possible to prevent cross-contact.

So how can you make the most of your Allergen Control Program? Use these 6 Best Practices in this e-book, co-produced by TraceGains Inc. and AIB International. Click here to download.