Single Identity Test For Botanicals "Makes Sense" - Israelsen

The use of multiple tests to confirm the identity of botanical ingredients is inappropriate, especially for small manufacturers of dietary supplements, Utah Natural Products Alliance Executive Director Loren Israelsen told FDAers at a public meeting on supplement GMPs in Salt Lake City, Utah Sept. 28.

Touching on what appears to be one of the more sensitive issues surrounding the development of Good Manufacturing Practices for dietary supplements, Israelsen suggested identity testing of botanicals or herbals "will be probably the most expensive element for many small companies as it relates to finished raw material from a certified vendor."

"Clearly, it seems to me, there's no need to have multiple confirming tests," Israelsen stated. "Simply one chemical identity test makes sense."

The advance notice of proposed rulemaking on supplement GMPs, published by FDA in the Feb. 6, 1997 Federal Register, would require only one test to confirm the identity of a botanical ingredient. The ANPR, which presents an industry-drafted set of GMP standards, says: "Each lot of raw material shall undergo at least one test by the manufacturer to verify its identity" (¹ (Also see "Industry dietary supplement GMP proposal published for comments in ANPR." - Pink Sheet, 10 Feb, 1997.)).

However, a recent draft report by a GMP working group of the FDA Food Advisory Committee called for multiple tests to confirm the identity of supplement ingredients (² (Also see "Herbal/Botanical Ingredient Identity Multiple Testing Recommended By FAC" - Pink Sheet, 5 Jul, 1999.)).

The Sept. 28 meeting was the second of three designed to solicit comments (³ (Also see "Supplement Defect Action Levels To Follow GMP Reg - FDAer" - Pink Sheet, 4 Oct, 1999.)).

At the agency's first small business meeting on the GMP issue, an American Herbal Products Association rep suggested FDA exempt small raw material batches from multiple test requirements because of the burden on smaller firms (⁴ (Also see "GMP Identity Test Exemption For Small Ingredient Batches Suggested To FDA" - Pink Sheet, 19 Jul, 1999.)).

"You're not going to see a lot of raw material botanicals in the future as products become more sophisticated and small businesses are really going to struggle with this," Israelsen maintained.

Many foreign vendors produce botanical ingredients under pharmaceutical standards but sell the products as dietary supplements in the U.S., he noted, adding these suppliers have been audited and inspected "very carefully at various levels - governmental and by U.S. companies" with which they do business.

"I would have absolutely no question" regarding the reliability of analytical tests such vendors would provide with their finished materials, he added.

"As small companies need to rely more and more on other vendors in a value-added process, they're going to get stuck with multiple tests that seem to be truly redundant and yet add a significant amount of cost in the process," Israelsen continued.

"Having said that, I think the raw material testing element is going to be very difficult as well for small companies because of the small lot size, but the...size of testing remains relatively constant," he said.

Relationships between manufacturers and raw material suppliers "are changing a lot," Israelsen stated, noting the average cost of raw materials has risen "probably a factor of 10-fold over the last 10 years, so whereas people used to pay $10 a kilo they're now paying $100 a kilo."

"That complicates things for small businesses because they are buying quantities that are relatively small," he stated. A large manufacturer dealing with much bigger lot sizes is able to "amortize the costs of those tests over thousands of pounds per lot," which can make the cost "absorbable," the industry rep noted, "but for small businesses, this is going to be a real problem."

In recent written comments to FDA, Captek Softgel International, a softgel contract manufacturing firm with 105 employees and about $13 mil. in annual sales, points to the "financial burden" certain provisions of the ANPR, particularly the identity testing requirements, would have on the company.

Captek says it produces 300 products using 500 active ingredients. "To test the different ingredients and products, we would need to invest $120,000 on additional equipment and staff two additional analytical chemists at $80,000 to $90,000 per year," the company maintains.

Development and validation of the necessary identity tests would take up to six months, Captek adds, "especially for situations where no acceptable method or information exists."