Supplement Safety

FDA employee Brad Williams '71 battles to keep tabs on this multi-billion dollar industry

by Noah Leavitt

You've seen them in your supermarket or drug store.

Row upon row of vitamins, minerals, and herbs promising dramatic results-weight loss, smoother skin, or a stronger immune system.

These are just some of the items making up the multibillion dollar dietary supplement industry. And, there's a good chance you're one of the millions of Americans taking some type of supplement.

But, how do you know that what you're ingesting is safe? How do you know that your Iron supplement contains just Iron? How do you know that vitamin promising to boost your immune system will actually protect you during flu season?

One of the people tasked with answering those questions is Brad Williams '71. The Chemistry alumnus has been working for the Food and Drug Administration (FDA) in various roles since 1975. And for the last decade, he has been working as a Consumer Safety Officer-keeping a close eye on dietary supplement manufacturers in the United States and abroad.

It's a job rooted in lab work-analytical chemistry to be exact-but with implications that affect many of us. Williams' journey to this important role at the FDA took some time-and in his opinion-a little bit of luck.

After graduating from Avon Old Farms School in Connecticut, Williams started his college career at Washington University in Saint Louis, before transferring to Boston University in 1967. At the time, he was taking night classes at BU, but wanted a full-time option.

"Curry stood out," Williams says. "The headmaster at my prep school had sent several people to Curry and thought very well of the school."

At Curry, Williams learned the skills that would shape his professional career:  chemistry and biology.

"I got to know Dr. Ralph Carleton [Head of the Chemistry department at the time] very, very well," Williams says. "When I started, I planned to major in biology, but then I started working with Dr. Carleton, and he started mentoring me and persuaded me to major in chemistry."

Williams built a strong academic and personal bond with Dr. Carleton. Over the years, Williams and his wife Patricia became close friends with Dr. Carleton and his wife Lulu.

"He was a great teacher, really good with people. He would trust people and work with them very well. I'm very honored to have known him," Williams says.

After graduating in 1971, Williams worked in labs around Boston, before landing a job with the Department of Veterans Affairs in Rhode Island. That job was funded by a research grant, and when it expired in 1975, Williams applied for- and was offered-his first job with the FDA.

Williams did not always envision becoming a Consumer Safety Officer. After all, his background was as a chemist- working in the lab. But, that science background makes Williams a perfect fit for his current position. He acts as an investigator in the FDA's Center for Food Safety and Applied Nutrition in College Park, Maryland. More specifically, Williams works in the Division of Dietary Supplements, which falls under the umbrella of the Office of Nutrition and Labeling. It's an office of 70 people overseeing hundreds of field investigators across the United States.

Williams' work on dietary supplements began in 2003- nine years after Congress first gave the FDA new authority on dietary supplement manufacturers. At the time, the FDA was in the midst of developing a new rule that would track exactly how supplement manufacturers made their products. That regulation, finalized in 2007, requires companies to follow current Good Manufacturing Practices (GMP).

It gave the FDA a new tool to affect change on a growing industry. Williams and his team have to fill in those gaps and make sure that the products on store shelves meet minimal quality standards.

"There's a perception that dietary supplements are completely unregulated. But it really isn't reflective of the truth. FDA has always had the authority to take action when something is hurting people," Williams says, while also acknowledging the difficult challenge he faces. "If you want to market a drug you have to put in a new drug application with evidence that your product is safe and effective for its intended purpose. Whereas dietary supplements are regulated as a category of food and don't have to prove to the FDA that they are safe and effective before being marketed."

In other words, dietary supplement manufacturers face a lower burden to prove the safety of their products, compared to drug companies.

Similarly, a dietary supplement cannot promise to act like a drug by treating, curing, or mitigating a medical condition. But, supplement makers can make so-called structure function claims; for example, "calcium builds strong bones."

"A consumer looks at the bottle of tablets and he or she may not understand that subtle difference," Williams explains. "If they pick up Vitamin D tablets is it really Vitamin D? There's really no way to ensure that unless there are some manufacturing standards."

It's a scientific version of the old cliché, "don't judge a book by its cover." Just because a dietary supplement is on store shelves doesn't mean it's necessarily safe, or even that the ingredients are accurate. You can only do that by taking a close look at the way a product is made, and documenting every step a company takes along the way.

"One of the rules we have is you can't test compliance into a product at the end once it's manufactured," Williams says. "I mean, you can do testing and say, yes it's 100% of what it says it is, but that doesn't necessarily ensure that it will perform the way you want it to."

That's why the 2007 dietary supplement rule requires companies to maintain written procedures about their manufacturing process, follow those
procedures, and then document that those procedures are being followed.

Still, the system cannot always prevent manufacturers from spiking products with chemicals that could prove dangerous to consumers. FDA has found almost 400 supplements spiked with Active Pharmaceutical Ingredients since 2008. Firms have recalled such products for containing ingredients like the banned chemical sibutramine (known commercially as Meridia). The appetite suppressant had been linked to events such as heart attacks and strokes in some patients.

Sometimes manufacturers are deliberately trying to mislead consumers. In other cases, Williams says companies may not test the identity of their incoming ingredients, and instead simply trust suppliers that they have been doing business with for decades.

It's a difficult job for people like Brad Williams, and it will only get harder as the supplement industry continues to grow. He estimates that there are 55,000 products on the market, produced by up to 2,000 manufacturers. And in the 2012 fiscal year, FDA investigators were able to inspect 341 of those companies. That includes some inspections of overseas factories-making the agency's job even more difficult.

"There are far more firms than we have people able to cover them," Williams admits.

However, stepped up efforts to enforce good manufacturing practices for dietary supplements have made many in the industry take the rule seriously, partially due to a number of criminal cases that have resulted in injunctions and seizures of products that don't meet GMP.

While criminal charges may be brought against offending firms, Williams says that is a last line of defense to protect consumers.

"The goal is to affect change rather than punish people," Williams says.

He believes that the dietary supplement rule will continue to do that-force companies to tighten up their operations, become compliant, and ultimately create quality products for consumers.

Of course, that is the goal for Williams, and everyone at the FDA. And, it's why he urges college students with an interest in science to consider careers in food, drug, or supplement safety.

"I've found it to be personally rewarding work," Williams says. "When you do something that solves a problem, especially when it deals with
situations with people possibly getting hurt, it's incredibly satisfying."


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