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Quality, testing are key priorities in sourcing ingestible materials

A rash of supplier quality issues has global buyers of ingestible materials on alert. But global sourcing of ingredients doesn't have to be risky if supply chain professional do their jobs.

By David Hannon -- Purchasing, 8/16/2007

With recent horror stories about contaminated pet food and tainted toothpaste filling newspaper headlines, supply chain visibility is coming under scrutiny in today's global market. Perhaps nowhere is it more important than when it comes to global sourcing of ingestible materials and ingredients such as nutraceuticals.

When it comes to best practices in sourcing of ingestible materials and ingredients, the resounding message that comes through from experienced buyers in the market is: get control and visibility of your supply chain, no matter how long it is. Don't buy anything if you haven't done a thorough, in-person inspection of the supplier's facilities and processes.

Larry Kolb is president of U.S. operations at TSI Health Sciences in Missoula, Mont., a maker of dietary supplement active ingredients and some over-the-counter drugs. He says "it's an interesting time to be in the dietary supplement market because we've seen growth and with the growth comes a lot of issues." Kolb adds that the recent stories of pet food and toothpaste contamination are a sign that there needs to be tighter worldwide standards on quality and inspection of ingestible materials.

But until there is, it's up to the buyers and quality personnel to ensure that what they are buying for their products is safe and clean.

TSI Health Sciences may know this better than most companies its size because it was originally a distributor of supplement ingredients, buying from one source, inspecting the materials and selling to another source. As a distributor, the quality of materials and suppliers was a constant concern both on the buy and sell side of its business.

"The average supplement company has to source globally to remain cost-competitive, but typically doesn't have the resources to travel overseas and continually evaluate the practices and quality programs of suppliers of all the ingredients they buy," Kolb points out. And a supplier audit doesn't take place in the front office, Kolb says, because while the supplier's front office may look professional, "the actual production might be a very primitive process at some plants. The buyers may be collecting and standardizing the best they can, but if the production happens at a low-cost, low-quality facility, it may lead to contamination issues. This 'cottage industry' production is caused or supported by the cost pressures and lack of regulatory pressure on the market."

Kolb says the lack of visibility into the manufacturing process for ingestible materials and supplement ingredients eventually became too much of a concern for TSI as a distributor, so the company shifted to a manufacturing model where it could better control the processes and ingredients in the products it sold.

Today, TSI has three manufacturing facilities in China which are run to meet U.S. standards. "We've completely restructured our business so we can give buyers complete assurance that our materials are safe and represent the specifications we manufacture to," Kolb says. "That's how we addressed the global crisis on quality—we manufacture more in-house to give us more control of our supply chain."

Large multinational firms like consumer products giant Procter & Gamble hold a distinct advantage in global sourcing by having buyers located in various global regions to provide visibility into the multiple levels of supply. This is especially beneficial when Cincinnati-based P&G sources its wide swath of ingestible ingredients for its food and dietary supplement brands, such as Metamucil, a dietary fiber supplement.

For example, P&G buys psyllium, a plant used in the production of Metamucil, from suppliers in India. Bill Cortner, director of edible ingredients purchases, says P&G's local buyers in India have a much closer feel for the supply market in India and can ensure that product meets not only local standards of quality, but also P&G's internal standards which it applies across its geographies and markets.


Cortner: “We don’t test different materials at different levels. Everything has to meet the P&G standard.”
"We don't test different materials at different levels," Cortner points out. "Everything has to meet the P&G standard regardless of where it comes from or where it goes to."

Testing the ingestible ingredients and materials is not as formulaic as it may sound. Many smaller companies use third-party laboratories to test the ingredients being sourced, but Kolb points out that "some third-party labs provide a pass document that is not accurate. Most of the labs are very credible but struggle with testing methodology to test these ingredients."

Elan Mikel Sudberg is the COO and laboratory manager at Alkemists Pharmaceuticals, a Costa Mesa, Calif.-based third-party testing laboratory for the nutraceuticals industry. "We're sort of middlemen in the quality control process," Sudberg explains, noting that his firm could be hired by companies up and down the supply chain, from raw material growers to buyers at processors or end-customers.

Sudberg sees dramatic variances in the amount of testing and research companies do on the ingestible ingredients they source. "Some companies go way beyond what's necessary or what's practical and others are going purely on blind faith," he says. "And it isn't dictated by size—some big companies simply accept a lab report from the supplier on faith."

While the testing process for ingestible ingredients and nutraceuticals may seem very complex, Sudberg points out that the first test should be identification—is the product what it says it is?

"Often products from suppliers overseas come with a certificate of analysis but there's nothing about identity on it," he says. "It makes no sense to test for pesticides or metals on the wrong product or material."

Sudberg warns buyers to look out for "blackmail laboratories" performing unsolicited "random testing. Some less-than-reputable labs take products off store shelves and test them. If the product is not labeled properly, the lab approaches the maker with the results, threatening to take the results public if their lab is not contracted by the manufacturer as the analysis firm.

Cortner says buyers at companies should take advantage of industry groups such as the Consumer Health Products Association to gain best practice and benchmarking insight.

 

Keys to successful sourcing of ingestible ingredients overseas

  • Audit suppliers in person whenever possible with a quality expert.
  • Know and understand the validation and certification processes presented by suppliers—if you're accepting them from a supplier, you need to know what they are.
  • Ask your suppliers about their suppliers. Get details and references.
  • Encourage third-party evaluations and certifications at your suppliers, at your company and at your customers.
  • Include identification testing in your processes.
  • Join industry groups to gain access to best practices and benchmarking ideas.

GMPs issued for supplement industry

The Food and Drug Administration in late June issued a long-awaited final rule outlining good manufacturing practices for dietary supplements. According to a statement from the FDA, the final rule includes requirements for "establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for record keeping and handling consumer product complaints."

Under the final rule, manufacturers are required to evaluate dietary supplements for:

  • Identity
  • Purity
  • Strength
  • Composition

"If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded," the statement says.

Larry Kolb, COO of TSI Health Sciences in Missoula, Mont., says the timing of the issuance of the FDA's rules has more to do with the "crisis of quality" in the supplement industry than anything else. Kolb says the stories of contaminated pet food and toothpaste may get worse, especially in the supplement industry, which has seen dramatic growth without any manufacturing standards in place.

The interim rules are effective August 24 and the FDA will collect comments on them until September 30.


For more information: Consumer Health Products Association

Also read: Procter & Gamble puts new spin on global chemicals sourcing

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