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How Will the Supplement Industry Fare without Hatch?

Around The Web  |  By MedPage Today  
   January 04, 2018

Utah senator dramatically changed supplement regulation

This article first appeared January 3, 2018 on Medpage Today.

By Shannon Firth

With the announced retirement of Sen. Orrin Hatch (R-Utah), the supplement industry may have to look for a new champion.

Hatch, the longest serving Republican in the Senate, announced plans to retire in early 2019, according to The Salt Lake Tribune. He was one of the primary authors and "the moving force" behind the Dietary Supplement Health and Education Act (DSHEA) of 1994, according to Marc Ullman, JD, of counsel at Rivkin Radler on Long Island, New York.

"It is not possible to adequately state the magnitude of the impact Senator Hatch had on the supplement industry," Ullman told MedPage Today. Rivkin Radler's clients include members of the supplement industry, and the firm has been involved in cases related to the scope of the FDA's powers in relation to such products, according to its website.

Until DSHEA, the FDA held supplements to the standard of drugs, which Ullman described as "anything intended to treat, cure, or prevent disease in man or in animal or to affect the structure and function of the body."

But "DSHEA expressly said that the structure-function clause did not apply to dietary supplements," Ullman said.

Instead of being regulated as a drug, supplements were treated as food products, according to Michael Carome, MD, director of Public Citizen's Health Research Group.

The supplement sector grew from a $9-billion industry in 1994 when the bill passed to a $35-billion industry by 2013, reported the St. George News. In Hatch's home state of Utah, the supplement industry makes $7 billion annually, according to the same St. George News article.

DSHEA also included one very significant grandfather clause stating that any ingredient on the market at the time of the bill's passage would be legal and not subject to FDA review, Ullman explained. Hatch fiercely protected this clause, and pushed for "guidance and clarity and fair treatment" in the FDA's review of new ingredients, he added.

He also pressed the agency to take aggressive action against illegal ingredients, promoting the law's enforcement "in a manner that protects the legitimate, bona fide, mainstream supplement industry," Ullman said.

“Any FDA reforms in the past 35 years, Sen. Hatch’s fingerprints were on it,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association in a phone call.

“No one has passed as much legislation for the country or the FDA as Senator Hatch has,” he continued.

As for his understanding of healthcare, “I can’t think of another legislator who has the breadth and depth that he did. So, it’s a huge loss,” Fabricant said.

 

His ability to “reform and expand” industries extends beyond dietary supplements to drugs and biologics, Fabricant said, citing the Hatch Waxman Act of 1984, which opened the door to generic competition.

But one aspect of his career that’s often overlooked is the consumer protection aspect of his legacy, he continued.

Hatch helped pass the Nonprescription Drug & Dietary Supplement Consumer Protection Act of 2006, which mandated adverse event reporting for both dietary supplements and over-the-counter drugs, Fabricant noted.

His co-sponsors Sen. Dick Durbin (D- Ill.) and former vice president, then Sen. Joe Biden (D-Del.) were critics of FDA-regulated industry but Hatch, who was skilled at working across the aisle, managed to broker an agreement, he continued.

Hatch was also quick to give advice to his industry colleagues.

“Government can change your business quicker than anything, for good or bad. So, get involved,” Fabricant recalled Hatch saying.

The supplement industry showed their support for Hatch. The website OpenSecrets.orgreports that during the 1993-1994 election cycle, Hatch was the number one Senate recipient of contributions from members of the nutritional and dietary supplement industry, totalling $95,750. Former Sen. Tom Harkin (D-Iowa), DSHEA co-author, received $40,250.

In the 2015-2016 election cycle, Hatch ranked third in contributions from the supplement industry ($29,600), behind Sen. Marco Rubio (R-Fla.) who received $34,700, and Sen. Martin Heinrich (R-N.M.) who received $39,250.

Ullman noted that Heinrich "has shown very strong support for the trade."

Carome said he viewed DSHEA as weakening FDA regulation and oversight of dietary supplements.

"It took the agency in a direction it did not want to go," he told MedPage Today.

Before the law passed, the FDA was concerned about the potential links between supplements and serious health problems. For example, the use of L-tryptophan, advertised for treating insomnia, was tied to an outbreak of eosinophilia-myalgia syndrome, with more than 37 deaths were linked to the supplement, he added.

The passage of DSHEA "really resulted in deregulation of the industry," Carome concluded, noting that the industry has "exploded" since the bill passed.

He also noted that post-DSHEA, "hardly a week goes by now when the agency isn't putting out a warning about various dietary supplements that have been tainted in some way."

Products often don't contain the ingredients they say they do and consumers don't realize this, he added. For instance, an investigation by the New York Attorney General of four major supplement retailers found four in five products didn't contain the herbs listed on their labels, according to a 2015 New York Times report.

Carome said he did not think Hatch's departure would adversely impact the supplement industry. "[DSHEA] is so ingrained now, Hatch's departure is likely to have little impact on the regulatory landscape of dietary supplements. It's unlikely we'll be able to turn the clock back."

Hatch's departure also opens up a spot for a new chair of the Senate finance committee. It isn't yet clear who will fill that role, wrote Doug Holtz-Eakin, PhD, president of the conservative American Action Forum and a former Congressional Budget Office director, in an email to MedPage Today.

He suggested that Sen. Chuck Grassley (R-Iowa) would have the option, but he may choose to stay on the Judiciary Committee that he currently chairs. Another candidate could be Sen. Mike Crapo (R-Idaho), but he would have to give up the Banking Committee chair, he noted.

Regarding the priorities of the next finance committee chair, Holtz-Eakin said, "I think that the health agenda will be more driven by the needs for entitlement reform than by the policy preference of the chairman. Whoever is next would work on the same ACA, CHIP, Medicare, and Medicaid issues that Hatch would have faced."

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