Existing amendments cover most of what ‘DSHEA 2.0’ would do, AHPA says

By Hank Schultz contact

- Last updated on GMT

Related tags: Regulation, DHSEA

Before rushing into an amendment of DSHEA it’s wise to consider how the law has already been modified and how full enforcement of those provisions might accomplish what the modification advocates have in mind, a trade organization cautions.

Micheal McGuffin, president  of the American Herbal Products Association, spoke with NutraIngredients-USA at the recent SupplySide West trade show in Las Vegas, NV.  McGuffin said in AHPA’s view there is a lot of value in the Dietary Supplement Health and Education Act as it stands.

DSHEA significantly different now than it was 25 years ago

“Where APHA ends up is, we kind of like DSHEA 1.0, or, if we’re more accurate, let’s call it 1.1, because that law has been modified in the last 25 years in some pretty significant ways,” ​McGuffin said.

The first big modification came as part of the Bioterrorism Act of 2002 that required among other things that every company that sells food in the US, including dietary supplement companies, to be registered with the Food and Drug Administration.   That act also made it easier for FDA to trace problematic ingredients by forcing companies to open their books as to where they bought the ingredient from and who they sold  it to.

McGuffin also noted that FDA now has mandatory recall authority in the food and supplement realm as part of the Food Safety Modernization Act, which amended the Food Drug and Cosmetic Act of which DSHEA is a part.  That’s a power the agency does not even have over the nation’s drug supply, McGuffin noted.

Probably the most significant change was the institution of the adverse event reporting requirement, which has been in place since 2006.

“That’s a burden we agreed to take on ourselves because we thought it address the primary value of consumer safety,”​ he said.

Product listing:  Solution in search of a problem

One potential amendment of DSHEA that has been much discussed in industry is that of a mandatory product listing, in which every product prior to going to market would submit product information to FDA.

McGuffin said AHPA’s members are not in favor because in their view most of what such a listing would accomplish is already being done.

“Our members have said, what’s the problem this is supposed to solve, would it solve it and would it be enforced?”​ McGuffin said.

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