Grappling with a "Great Mountain of Paperwork" (Part 2)

To read part 1, please click here. .

Jim Lassiter of Ingredient Identity educates the audience on the importance of understanding and verifying the identity, purity, strength and composition of ingredients.

Lassiter also underscores the distinction between claims that dietary ingredient manufacturers make about the stellar benefits of their products (i.e., "helps to regulate total cholesterol levels and decreases blood pressure") and what youthe dietary supplement marketercan lawfully state.

At the noon buffet, I meet a few gentlemen with a contract manufacturer in Utah. We shoot the breeze about the rain that keeps falling, concealing the Flatirons and swelling nearby Boulder Creek. We wonder if anyone is hanging out on Pearl Street. Moments later, an affable label consultant sits down next to me, sharing a tale about a client, an Apache shaman, and extraterrestrials.   

When we return to planet earth, Randy Giboney of Western Botanicals, Dino Guglielmelli of Creation's Garden and Dean Kramer of Ortho Molecular Products share their stories of FDA inspections.

Giboney explains the terrible timing of an FDA inspection: a young auditor showed up the week his quality assurance manager happened to be gone. The auditor was congenial the first day. On the second day, he got down to business. And he began to dig deeper and deeper into Western Botanical's operations.

"He asked for all kinds of records, every kind of record you can think of," Giboney recalls. "His primary focus was on documentation. If it wasn't written, it didn't happen."

Giboney was insulted when the auditor claimed his firm didn't do any testing; he points out Western Botanicals spent hundreds of thousands of dollars on equipment and personnel.  

Giboney says he signed a Form 483 under penalty of perjury because the auditor told him he had to do so. Afterwards, he learned from his lawyer he didn't have to sign anything.

After the auditor left the building, Giboney called American Herbal Products Association President (APHA) Michael McGuffin, who advised him to contact a veteran attorney.

Western Botanicals spent about 1,000 man hours responding to FDA. Giboney had some advice for firms who are going through an FDA audit.

"Only give the inspector the information he asks for," he says. "Dont elaborate until it's requested."

Giboney maintains the inspector wasn't very helpful when he asked him about a specific cGMP problem that the young man noted. The auditor allegedly responded that the information was in the regulations.

Still, Giboney acknowledges the inspection was beneficial because it forced the company to closely examine its business. He says Western Botanicals now has better training, documentation and stronger SOPs.

One audience member leans into FDA, indicating the agency makes broad statements in warning letters that exaggerate or misrepresent non-compliance with cGMPs. (The gist of his argument: there is a difference between having absolutely no documentation or testing, for example, and certain deficiencies in these areas; it was implied that FDA fails to make the distinction in warning letters).

Brad Williams, a former FDA official who now works with the third-party auditor NSF International, was quick to come to the agency's defense.

"FDA's goal has always been to achieve compliance in the most reasonable way possible," he declares.

Addressing an assertion that "adulteration" is a "loose" term, Williams responds: "It's a loose term but it's a legal term." (He's referring to warning letters in which FDA advises a company that its products are adulterated; the term is defined in 21 U.S.C. § 342). 

If readers are dreading an FDA audit, be grateful if you are not Creation's Garden. Guglielmelli says the company endured an eight-week FDA audit.

"Give them what they ask for. Don't give them any more," he advises the audience.  

He also urges his peers to refrain from signing any documentation following the completion of an FDA inspection.

"Don't sign anything," Guglielmelli says. "It comes right down to an opinion."

Kramer of Ortho Molecular Products also has a recommendation for his peers: prepare for an FDA audit or face the certainty of failure.

"Everyone should have a procedure for an FDA inspection," he says. "You want to prepare for the audit any day."

Later in the afternoon, Cara Welch, Ph.D., of the Natural Products Association (NPA), appears to acknowledge the difficulty of dealing with companies that utterly fail to follow GMPs.

"I don't do enough to get rid of the 30 percent but it would be nice to get them in a room somewhere," Welch, NPA's senior vice president of scientific and regulatory affairs, says. But she admits she doesn't know the identity of these companies.

Welch prefers to highlight the behavior of companies that are in compliance with cGMPs.

Roy Upton, founder and executive director of American Herbal Pharmacopoeia (AHP), acknowledges it is difficult to police the 30 percent of firms that are giving the industry a bad reputation.   

"They are there for the bottom line," he says.

Perhaps, supplement firms should worry less about what their competitors aren't doing and more about what measures they are implementing to prepare for an FDA audit and avoid the issuance of a Form 483.