Small companies such as Attune Foods must also qualify the quality systems of the copackers and contract manufacturers they use and understand the ultimate sources of their ingredients.
Now he’s president/CEO of Attune Foods, San Francisco, a venture capital-backed functional food company that makes innovative Probiotic Wellness Bars, which deliver over five times the live active cultures of yogurt.
Hurlbut still is dedicated to source verification. But it is now more complex, requiring close relationships both upstream to ingredient providers and downstream to delivery of product.
“Small companies have a challenge in that they often must use copackers and contract manufacturers and still guarantee food safety and quality,” he says. “Attune Foods invests heavily in controls that are designed to prevent worst-case scenarios. Recent outbreaks have raised customer awareness of ingredients and source verification is critical to maintain consumer trust.”
Ingredient suppliers on guard
Ingredient suppliers are heeding the message, as well.
“FutureCeuticals prides itself on providing high quality ingredients to our customers,” says Colleen Zammer, sales director for FutureCeuticals Inc., Momence, Ill. FutureCeuticals specializes in the discovery, development, manufacturing, processing, growing and marketing of scientifically innovative nutraceuticals, functional foods and cosmetic ingredients.
Rapid screening using an automated immunoassay instrument is used by an FDA chemist to detect cell surface antigens of salmonella on food products.
“The type of products and technologies we provide are standardized for functional nutrients that have a measurable affect on the body. Quality is imperative so they not only look and taste as they should, but so we meet our own specifications for those functional nutrients. These natural, health-enhancing products cannot be adulterated with anything that would be detrimental to health,” says Zammer.
“This is not always an easy task, especially in the natural products sector where variation occurs – naturally,” she continues. FutureCeuticals carefully records the critical elements of each of the products it brings in as raw materials and analyzes the finished goods for specific quality-related attributes.
“We have expanded our in-house testing capabilities over the years to be able to detect new actives or adulterants that have emerged on the scene. We also work closely with a couple of key external laboratories that are specialists in certain analyses that we need to leverage on occasion. One cannot be an expert in everything, and as a relatively small company we are perfectly happy to leverage the capabilities of others to provide credible and objective analysis of our products,” says Zammer.
FDA’s mission ‘at risk’
On Dec. 3, 2007, the FDA’s Science Board, an advisory committee, adopted the findings and recommendations of its subcommittee issued in a report called, “A Mission at Risk.” This ominous report in summary said the following:
There has never been a greater need for an effective FDA to ensure the safety of our foods, drugs, vaccines, medical devices, and a host of other products.
The FDA, which traditionally has been one of the government’s most trusted agencies, with scientists and regulators recognized worldwide for their skill and dedication, is being allowed to wither away, its tradition of excellence eroded by lack of support from Congress and the White House.
The demands on the FDA have soared in recent years as 50 percent of our drugs and 15 percent of our food supply are imported. Yet, the FDA has lost 20 percent of its scientists and hundreds of inspectors in the past three years.
Scientific advances in medicine and technology are exceeding the FDA’s regulatory capacity, a situation that threatens our technological competitiveness and economic future.
The FDA’s information technology systems are outdated and inadequate, posing a threat to its public health mission.
The FDA’s capability cannot be restored to its former stature of consumer protection without determined effort from Washington. Without action, the cost to our society will be far greater than the costs of rebuilding the FDA.
“We also review our specifications and certificates of analysis on a regular basis to ensure we are well within compliance of the standards we have set,” she says. “If we see any trends in drifting data, we have a multi-disciplinary team comprised of management, production and QA/QC review and address the situation.”
Cargill Inc., Wayzata, Minn., operates in 66 countries, which makes maintenance of the quality of the food chain at once complex and critical to its success. “Cargill's position has been to establish prerequisite programs, such as Good Manufacturing Processes (GMPs) and Hazards Analysis and Critical Control Points (HACCP). These programs must be evaluated and validated,” says spokesperson Mark Klein. “We require that of our suppliers, too. In addition, suppliers should be visited and audits conducted."
For DSM Nutritional Products, Parsippany, N.J., an international supplier of vitamins, carotenoids and other chemicals to the feed, food, pharmaceutical and personal care industries, it is not where products are made, but how they are made.
“The main issue is not about bashing China but about creating a level playing field where all suppliers and manufacturers have to adhere to the same quality and environmental standards globally,” says Todd Sitkowski, senior marketing manager. “Our customer presentation titled ‘A Partnership of Trust’ highlights our quality approach with products and services as well as our relationship with our customers.”
The DSM Partnership of Trust program focuses attention on the three most important areas of food chain integration: quality, reliability and traceability. Quality certification standards – such as cGMP, ISO 9001 and ISO 14001, USP, EUR.PHAR, FCC, HACCP, and Kosher and Halal certifications -- are strictly adhered to. As the source of raw materials, DSM selects only reliable suppliers that meet DSM’s stringent specifications.
With an integrated global and local supply chain, global manufacturing sites and a commitment to customers, even in crises, DSM takes its role as a good corporate citizen seriously. “Selecting anything less than quality ingredients places the entire food chain at risk,” says Sitkowski.
Ingredients now come from all over the globe, and at a time when the FDA’s public health mission has been compromised. Recent contamination incidents of food and drugs and the consequent erosion of consumer trust is acting as a kind of Darwinian selective pressure, favoring those companies that take the quality of the food chain the most seriously. It’s a matter of simple evolution.
“The notion of guaranteeing food safety from ‘field to fork’ is no longer possible for any one industry,” sums Heidolf. “Today, there are just too many factors for one company to control. You need to look one step above you and one step below, not just at your company. It should be a continuous learning supplier partnership in which all share the same goal: quality.”