Joanna Cosgrove08.29.11
Longtime supplement industry champion, Senator Orrin Hatch (R-UT) recently sat down, town hall meeting style, to discuss the issues most affecting the dietary supplement industry—namely the potential trouble that could come as a result of FDA's proposed New Dietary Ingredient (NDI) guidance. The meeting afforded supplement industry representatives the opportunity to impress upon Sen. Hatch how FDA’s NDI guidance, though well-intentioned, could wreak havoc on the supplement industry—which happens to be a lucrative part of the economy in the Senator’s home state of Utah.
More than 120 dietary supplement industry executives attended the meeting, which was held at Utah Valley University in Orem. The leaders of five industry trade association were also assembled for an NDI panel discussion. They were Loren Israelson, executive director, United Natural Products Alliance (UNPA); Steve Mister, president and CEO, Council for Responsible Nutrition (CRN); Michael McGuffin, president, American Herbal Products Association (AHPA); John Gay, executive director and CEO, Natural Products Association (NPA); and Scott Melville, president and CEO, Consumer Healthcare Products Association (CHPA).
UNPA’s Mr. Israelsen, whose trade association is headquartered in Salt Lake City, was quoted by the Salt Lake Tribune as saying that dietary supplements represent a $6.5-billion-a-year revenue to Utah. “We’re very concerned right now about the economic impact of this on industry because there are so many jobs at stake here,” he said.
Senator Hatch vowed to “fight tooth and nail to prevent premarket approval and hold the line on [the Dietary Supplement Health and Education Act (DSHEA)],” and encouraged supplement industry companies to “take an active role” in the ongoing NDI guidance process. He said he welcomed feedback on the NDI guidance, and encouraged the industry to submit comments “backed up with facts.” He noted that the five trade associations represented on the panel would be great resources for assistance with the commenting experience.
Senator Hatch also discussed his opposition to the Dietary Supplement Labeling Act bill introduced by Senator Dick Durbin, D-IL, which would require manufacturers to disclose any known ingredient or side effect risks. However he added, “There’s a balance here that has to be made and I just want to be sure people who take supplements are safe, and they are.”
During his panel presentation, CRN’s Mr. Mister criticized the excessive requirements to demonstrate safety that are identified in this draft guidance as necessary for an NDI—a standard that is nearly identical to a food additive petition. “FDA is essentially equating the two standards—which is exactly what DSHEA endeavored to prevent,” he said.
In addition, Mr. Mister expressed concerns about FDA’s position in the draft guidance that a synthetically derived constituent of a plant cannot be a dietary ingredient. FDA’s view, he explained, is that “if the ingredient is produced in a lab, no matter how bio-identical it is, it can’t be used in a dietary supplement—period. And no amount of safety data appears that it will change the agency’s mind.”
In an interview with Nutraceuticals World, Mr. Mister said that when the Dietary Supplement Labeling Act bill was discussed, the mood in the room was that the legislation would “hurt the industry and impose unnecessary bureaucratic requirements for registration and filing of labels, as well as the potential for adverse warnings on products that may be unnecessary,” he said. “There’s a pretty strong sentiment that that legislation is really problematic to the industry.”
When asked if Senator Hatch proposed any alternative ideas to counter Senator Durbin’s bill, Mr. Mister said that Senator Hatch believes DSHEA strikes the right balance between supplement safety and access. “He’s concerned that legislation like this will come along and revise that and push the balance too far in the other direction, which would mean consumers would not have access to products that they have come to appreciate,” commented Mr. Mister. “For a long time he’s been saying DSHEA works and there’s no reason why it doesn’t provide adequate consumer protection at the same time it protects the industry—but FDA needs to enforce it. I heard the same kinds of comments [at the meeting]. He expects FDA to enforce the law as it was written.”
A Q&A session concluded the panel discussion and a press conference followed. Senator Hatch closed the event by promising to “work hard to protect your industry” and “preserve DSHEA [so that] 150 million Americans have access to beneficial supplements.”
More than 120 dietary supplement industry executives attended the meeting, which was held at Utah Valley University in Orem. The leaders of five industry trade association were also assembled for an NDI panel discussion. They were Loren Israelson, executive director, United Natural Products Alliance (UNPA); Steve Mister, president and CEO, Council for Responsible Nutrition (CRN); Michael McGuffin, president, American Herbal Products Association (AHPA); John Gay, executive director and CEO, Natural Products Association (NPA); and Scott Melville, president and CEO, Consumer Healthcare Products Association (CHPA).
UNPA’s Mr. Israelsen, whose trade association is headquartered in Salt Lake City, was quoted by the Salt Lake Tribune as saying that dietary supplements represent a $6.5-billion-a-year revenue to Utah. “We’re very concerned right now about the economic impact of this on industry because there are so many jobs at stake here,” he said.
Senator Hatch vowed to “fight tooth and nail to prevent premarket approval and hold the line on [the Dietary Supplement Health and Education Act (DSHEA)],” and encouraged supplement industry companies to “take an active role” in the ongoing NDI guidance process. He said he welcomed feedback on the NDI guidance, and encouraged the industry to submit comments “backed up with facts.” He noted that the five trade associations represented on the panel would be great resources for assistance with the commenting experience.
Senator Hatch also discussed his opposition to the Dietary Supplement Labeling Act bill introduced by Senator Dick Durbin, D-IL, which would require manufacturers to disclose any known ingredient or side effect risks. However he added, “There’s a balance here that has to be made and I just want to be sure people who take supplements are safe, and they are.”
During his panel presentation, CRN’s Mr. Mister criticized the excessive requirements to demonstrate safety that are identified in this draft guidance as necessary for an NDI—a standard that is nearly identical to a food additive petition. “FDA is essentially equating the two standards—which is exactly what DSHEA endeavored to prevent,” he said.
In addition, Mr. Mister expressed concerns about FDA’s position in the draft guidance that a synthetically derived constituent of a plant cannot be a dietary ingredient. FDA’s view, he explained, is that “if the ingredient is produced in a lab, no matter how bio-identical it is, it can’t be used in a dietary supplement—period. And no amount of safety data appears that it will change the agency’s mind.”
In an interview with Nutraceuticals World, Mr. Mister said that when the Dietary Supplement Labeling Act bill was discussed, the mood in the room was that the legislation would “hurt the industry and impose unnecessary bureaucratic requirements for registration and filing of labels, as well as the potential for adverse warnings on products that may be unnecessary,” he said. “There’s a pretty strong sentiment that that legislation is really problematic to the industry.”
When asked if Senator Hatch proposed any alternative ideas to counter Senator Durbin’s bill, Mr. Mister said that Senator Hatch believes DSHEA strikes the right balance between supplement safety and access. “He’s concerned that legislation like this will come along and revise that and push the balance too far in the other direction, which would mean consumers would not have access to products that they have come to appreciate,” commented Mr. Mister. “For a long time he’s been saying DSHEA works and there’s no reason why it doesn’t provide adequate consumer protection at the same time it protects the industry—but FDA needs to enforce it. I heard the same kinds of comments [at the meeting]. He expects FDA to enforce the law as it was written.”
A Q&A session concluded the panel discussion and a press conference followed. Senator Hatch closed the event by promising to “work hard to protect your industry” and “preserve DSHEA [so that] 150 million Americans have access to beneficial supplements.”
