A representative with the Council for Responsible said most companies in the industry are following the law.

Josh Long, Associate editorial director, Natural Products Insider

September 17, 2015

3 Min Read
Dietary Supplement Industry Responds to DOJ Letter on Lawbreakers

The dietary supplement industry on Thursday expressed various reactions to a U.S. Justice Department letter, which claimed unlawful activity in the supplement industry “has become a massive, and wide-ranging, consumer protection problem." The agency also said it was making enforcement against such behavior a high priority in its consumer protection efforts.

“The declaration from the DOJ that the industry is a cesspool is outrageous," said Marc Ullman, Of Counsel at the New York-based law firm Rivkin Radler LLP, in a phone interview.

“It’s a mischaracterization of the supplement industry and what it points to is that people who are in the fraud business as distinguished from the supplement business … feel absolutely comfortable to market their frauds masquerading as dietary supplements because they are confident DOJ will do nothing about it."

Judy Blatman, senior vice president of communications with the Council for Responsible Nutrition (CRN), expressed gratitude that the Justice Department “considers fighting illegal activity in the supplement industry to be a high priority."

“The overwhelming majority of companies in our industry are following the laws, and these responsible companies are committed to ensuring that consumers have access to safe products," Blatman said in an emailed statement.

In the Sept. 9 letter addressed to Sens. Orrin Hatch (R-Utah) and Martin Heinrich (D-New Mexico), Assistant Attorney General Peter Kadzik cited problems of dietary supplements containing active pharmaceutical ingredients (APIs) and undeclared substances including known allergens, while he said several products are produced in facilities that don’t comply with GMPs (good manufacturing practices) and some other supplements are marketed as being able to treat diseases.

In a letter this past spring that was addressed to U.S. Attorney General Loretta Lynch, the senators expressed their concern about blatant criminal adulteration of products masquerading as dietary supplements.

“There is no place for companies illegally manufacturing unapproved pharmaceutical products and marketing them as dietary supplements," Blatman said.

Following the letter from Hatch and Heinrich, CRN also urged the Justice Department in a separate letter “to work more closely with FDA to implement a proactive regulatory and enforcement strategy to address this public health concern."

Natural Products INSIDER hasn’t been able to confirm the number of civil and criminal prosecutions that have been referred to the Justice Department and actually prosecuted in recent years to target unlawful behavior in the supplement industry.

But as INSIDER reported in July, since fall 2010, the government secured permanent injunctions against at least 15 companies that made and marketed dietary supplements. Since the article was published, FDA announced that four other companies in the supplement industry—including three Wisconsin-based businesses and an Iowa-based firm—have ceased operations.

The Justice Department’s letter marks the beginning of a dialogue, said Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA).

“I anticipate the next conversations will get more granular in detail, and we’ll start to talk about numbers," he said in a phone interview. “We are encouraged by the fact that they mentioned discussing things with industry partners, and we look forward to engaging the Department of Justice on fruitful dialogues."

Michael McGuffin, president of the American Herbal Products Association (AHPA), also commented on the Justice Department's letter to the senators.  

“AHPA appreciates the Department of Justice prioritizing enforcement action against illegal activity in the market," McGuffin said in an emailed statement. "AHPA also encourages the DOJ to mirror FDA’s effective prioritization of enforcement actions that targets those deliberately introducing misbranded drugs into the market while working with well-intentioned businesses to resolve minor infractions. DOJ should similarly prioritize enforcement actions from this public health perspective.”

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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