Until recently, American food manufacturers were operating under regulations that hadn't changed significantly in 70 years -- and it was time to shake things up. About 48 million people get sick from foodborne diseases every year, according to data from the Centers for Disease Control and Prevention.
In 2011 -- prompted by a series of nationwide outbreaks tainting everything from cantaloupes to peanut butter -- President Barack Obama signed into law the FDA Food Safety Modernization Act, a sweeping reform of American food safety laws aimed at keeping our food supply safe by shifting the focus to prevention.
The old system surrounding food safety was reactive, and went something like this: Discover a problem, investigate it, fix it, repeat. With its new rules, the FDA aims to prevent illness before it happens by anticipating, preventing, and validating during all stages of food production, from raw material production and procurement and handling to manufacturing, distribution, and consumption of the finished product.
The Food Safety Modernization Act has seven provisions, including the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food -- Preventive Controls for Human Food for short.
Preventive Controls for Human Food went into effect in November 2015, impacting all U.S. food manufacturers by creating new requirements for the production of food by registered food facilities -- requirements smaller food manufacturers might not totally understand, worries Larisa Pavlick, VP, global regulatory and compliance at the United Natural Products Alliance.
In addition to clarifying the definition of "farm" and modernizing the FDA's longstanding current good manufacturing practice regulations, Preventive Controls for Human Food requires registered food facilities to establish and implement a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of any hazards, says Pavlick.
"This rule will provide guidance for the manufacturing, holding, and packaging of food products in the U.S., and it also applies to products being imported, if they're intended to be sold or distributed in the U.S.," she explains. As she puts it, "The new regulation is more comprehensive, and it pushes it back to the manufacturer to be responsible for the food they're presenting."
The rule establishes requirements for a written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification, a supply-chain program, a recall plan, and record-keeping.
"If there is a risk associated with a food that's being produced, the manufacturer must develop a preventive control," adds Pavlick. "The manufacturer also has to have a recall plan."
The measures described above must be overseen by a Preventive Control Qualified Individual (PCQI) -- any person trained to implement the preventive controls developed through the food safety plan a company establishes. Any food company that manufactures, packages, holds, or distributes a food product using a Nutrition Facts panel is required to have a PCQI. This includes natural products and functional foods, such as protein shakes and energy bars. Dietary supplement companies are recommended to have a PCQI and are required to have a "qualified individual" to manage three portions of the new regulation.
Companies and products using the Supplement Facts panel are required to be fully compliant with 21 CFR Part 111-Dietary Supplement Good Manufacturing Practice (GMP); plus 21 CFR Part 117 Subpart A, including qualification of individuals; Subpart B for GMPs above and beyond those expected in 111, including an allergen management program; and Subpart F, which outlines extensive new records requirements. These three sections are the responsibility of a "qualified individual."
Dietary Ingredient (raw material) suppliers are classified as a food and therefore are subject to the full requirements. These suppliers include companies providing botanical powders used in dietary supplements, such as echinacea, gingko, and others. Any company distributing a dietary supplement would be expected to qualify their supplier of these ingredients to ensure they are compliant with the new regulation.
Some companies are worried that they'll have to go out and hire a new employee to cover the PCQI requirement. "That's not the case," Pavlick clarifies. "Somebody on staff can be trained to put together elements of the preventive control plan." For most companies, she adds, it will make sense to train multiple employees from various areas of operations as PCQIs.
Preventive Controls for Human Food is a food regulation, and it impacts all products that are marketed as food, natural supplements included. Dietary products won't have to comply with every aspect of the new regulation, but they will be required to have a "qualified individual" on-site. They'll also need to be compliant with record-keeping practices and procedures designed to prevent cross-contamination with allergens.
Because the Food Safety Modernization Act applies to imported products intended to be sold or distributed in the U.S., China -- a major importer of botanicals used in supplements -- will also be required to comply with the new law. What's more, any food manufacturer receiving products from overseas will have to verify that their supplier is meeting requirements. If the extra red tape seems like a pain, Pavlick asks manufacturers to consider the following argument for heightened regulation.
"Chinese herbs are amazing," says Pavlick, noting that many of them cannot be grown anywhere else in the world. "There are so many botanicals coming in from Asia that they simply can't be eliminated from the supply chain." With Chinese herbs, though, experts are finding a high incidence of heavy metals, pesticides, and other contaminants due to air pollution. "We can't replace the botanicals from many areas around of the world known for their strong traditional use, but we must be aware of the potential risks specific to the various countries of origin, including regional pollution, agriculture practices, storage techniques, and the relationship of these to potential contaminants."
The major regulatory shift outlined above brings heightened testing and monitoring expectations -- and, realistically, that might burden some smaller food manufacturers. The FDA did an economic impact study before it implemented its new regulations, explains Pavlick, noting, "There probably will be some impact." Preventive Controls for Human Food requires "more than most companies have done in the past with testing and monitoring," Pavlick says.
In September 2016, large companies with over 500 employees were required to come into compliance with Preventive Controls for Human Food. Most remaining companies -- those designated as "small businesses" with fewer than 500 full-time-equivalent employees -- must be compliant by this September. "Very small businesses" averaging less than $1 million per year in sales have another year to sort things out, but Pavlick points out that most companies won't qualify as "very small businesses" because of inventory reporting statement in the regulation.
"We've found that most of the companies out there are going to need to be compliant this year -- even some mom-and-pop shops aren't going to fall into the 'very small businesses' class," Pavlick says.
While the FDA has done some outreach, it's ultimately up to the company to comply with the new regulations. "Marketing isn't the FDA's job," says Pavlick, adding, "Most companies -- we're finding -- are very surprised by the new regulations."