FDA appears to be leaving some discretion to dietary supplement firms - or the industry at large - to establish their own systems for qualifying vendors in order to use certificates of analysis under the good manufacturing rule.

The agency outlined some examples of ways to qualify a vendor during an Oct. 24 satellite call on the GMPs.

However, the industry could use more guidance on qualification, Andrew Shao, the Council for Responsible Nutrition's vice president of scientific and regulatory affairs, said.

If FDA does not offer more direction, industry should step up and create their own standards, he suggested.

The GMP final rule says to qualify a supplier a manufacturer must "establish the reliability of the supplier's certificate of analysis through confirmation of the supplier's tests or examinations."

A manufacturer can rely on an ingredient supplier's certificate of analysis for verifying specifications other than identity - for instance, contaminants, according to the rule.

What FDA Does Not Say On Vendor Qualification

While FDA emphasizes in its final rule the importance of qualifying a vendor, it does not spell out what qualifying a vendor means, some industry experts note.

According to Shao, the agency does not provide enough details on how to qualify a vendor.

"There are industry 'best practices' that various manufacturers have been using for years in order to ensure product quality, but still, no one knows what FDA expects to see for qualification," Shao said. "This is obviously important now in the age of food safety and import concerns."

What FDA Does Say On Vendor Qualification

During the satellite call, Brad Williams, special assistant to the director of the Center for Food Safety and Applied Nutrition's Division of Dietary Supplement Programs, said a vendor can be qualified through "having some tests done to verify that that vendor's certificate gives good results."

"It could be by hiring a private auditor to go to the firm and do a private audit," he said. "It could be through several other mechanisms: asking the firm to supply lab books showing their results and their quality of laboratory work."

As far as providing further guidelines for qualifying vendors, Williams said the agency does not have much experience, but there is "private information available out there for that subject."

Certificates of Analysis

There has been some confusion on how to use a certificate of analysis for dietary ingredients, CFSAN's Division of Dietary Supplement Programs Director Bill Frankos said during the call.

For example, firms can use CoA in addition to confirming an ingredietnt's identity, but not in place of that requirement.

"What we're saying is dietary ingredients have to have their identity confirmed 100 percent," Frankos said. "A certificate of analysis does not meet that standard because the company has to do an actual test for identity".

However, a certificate of analysis can provide information on other contaminants or other toxins that could be present in the product, he said.

"The certificate of analysis might give you heavy metal analysis, tell you how much lead is in the product," he said. "Or if it's a natural product that has some known toxin, you could use that to identify the level of that toxin that's there.

For example, "We know [aflatoxins are] there for certain products so we like to have an analysis of it," Frankos said. "It could be microbial contamination. ... So, certificate of analysis could identify the microbial load of the product."

In addition, "other parameters that help assure the safety and quality of the product can be provided by certificate of analysis - if the company has been qualified that you're buying it from."

FDA is also leaving it to firms to determine the acceptable levels of contaminants.

Limits For Contaminants

Limits for heavy metals "will be established by the manufacturer, usually in working with the supplier of the ingredients," Frankos said.

"Every dietary supplement has its own usage pattern," he said. "There are different amounts that are consumed, as recommended on the label, and so we are not in a position to establish what is an acceptable limit for heavy metals in each dietary supplement."

Frankos said the responsibility is on the manufacturer. "The manufacturer knows their product the best," he said. "They know how much is consumed. They know the history of that product, that is, where the ingredients came from, what were the levels in the natural product that they may have bought."

As long as the firm rationally supports the limit it sets for its product, the information is provided to any inspectors, and it is scientifically valid based on published information, FDA will accept whatever the limits the firm sets, he said.

"We're not prescribing how to do this," Frankos said. "FDA does have some information on lead, that is how to establish what we call a tolerable intake level for lead, and we have some discussion about how to do this, but we are not establishing a specific limit" for dietary supplements.

FDA allows manufacturers to set their own limits because, "there are so many different supplements with different ingredients and different recommended dosages that FDA could not set limits that would pertain to all," according to Shao.

"For example, a product could have trace amounts of a contaminant, but a relatively large serving size, resulting in a high exposure," Shao said. "Conversely, a product may contain comparatively high levels of a contaminant, but the dose is so low, that exposure is negligible."

"As far as where can you get information, there are a lot of toxicological references that are available that establish levels that are considered acceptable for heavy metals. You may find that you want to use some EPA documentation, or WHO - World Health Organization - information," he said.

In most cases the limits set by those bodies simply don't apply in any way to supplements in terms of dose, frequency, and total exposure. This is definitely an area where the industry needs more guidance," Shao observed.

- Rebekah Moan

Supplement GMPs Leave Vendor Qualification Specs In Manufacturers’ Hands

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