The Consumer Health Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance all communicated their displeasure with the language of the bill that emerged from a hearing yesterday. Amendments offered by Sen. Mitt Romney, R-UT, that would have rounded off some of what the supplement industry considered to be the sharpest corners in the bill’s stipulations did not make it into the final version.
The bill is sponsored by Sen. Patty Murray, D-WA, who is the Chair of the Senate HELP Committee, and the panel’s Ranking Member, Sen. Richard Burr, R-NC. The measure’s primary purpose is to reauthorize the fees collected by FDA in the drug and medical device sectors.
Such bills are usually boilerplate affairs and rarely generate controversy. And, like the spending bills to fund the Federal government, they are destined to pass in one form or another. Indeed, the House fee authorization version (which contained no dietary supplement provisions) passed recently on a 392-28 vote.
But this year’s Senate version is different. It includes language meant, in Sen. Murray’s words, to “provide long overdue oversight of cosmetics and dietary supplements.”
CHPA and CRN have supported the concept of a mandatory product listing requirement, with CRN offering its Supplement Owl label database as a useful model for what the requirements of such a listing might be. UNPA had essentially carved out a position of being willing to consider the idea without overtly advocating for it.
Over broad, burdensome provisions
However, once the dust settled after yesterday’s committee hearing, the three trade organizations were unanimous that the provisions in FDASLA are too broad and could offer the potential for regulatory abuse as well as being costly and burdensome.
“While CHPA remains highly supportive of an appropriate listing system for dietary supplements that will enhance consumer safety, we are strongly concerned that the dietary supplement provisions of this legislation are overly broad and will place unnecessary and costly burdens on the entire industry. Moreover, the legislation falls short of the comprehensive reforms needed to appropriately and effectively modernize the regulatory framework for dietary supplements,” said Scott Melville, CHPA’s president and CEO.
Steve Mister, president and CEO of CRN, said increased transparency is a good thing for the industry, but the path laid out in this latest bill isn’t the right way to go about it.
“The outcome of today’s Senate HELP Committee vote on the FDA Safety and Landmark Advancement Act of 2022 (FDASLA)—which fails to include protections necessary for responsible industry to thrive—is highly disappointing,” Mister said.
“As the industry’s leading proponent for a federal mandatory product listing program operated by FDA, CRN remains steadfast in our belief that such a program can provide consumers and the agency the transparency they want and need from the marketplace,” he added.
“However, that transparency does not require confidential business information to go unprotected and should not necessitate trading away assurances that the authority to create the listing will not be misused,” Mister concluded.
UNPA: Without Romney’s fixes, bill is unacceptable
Israelsen said the changes suggested by Sen. Romney would have gone a long way toward fixing the bill. Without those changes, it’s circle the wagons time.
“We are extremely disappointed that the Senate HELP Committee failed — on a tie vote — to approve common sense improvements to the dietary supplement provisions in its FDA user fee reauthorization bill. UNPA thanks Senator Mitt Romney for his strong leadership in offering an amendment to improve these shortcomings,” Israelsen said.
“The Committee’s failure to approve the Romney amendment leaves UNPA no choice but to withhold support for the bill as ordered reported. We will be working with our membership and other trade associations to rectify the shortcomings as the bill moves to the full US Senate. UNPA remains hopeful that its recommended changes can be addressed and that a responsible and acceptable mandatory listing provision can be approved by the Congress,“ he added.
Four bones of contention
The three trade organizations stipulated four sticking points that must be resolved before the bill could be supported by industry. The stipulations would make it clear that a mandatory product listing may not be used as a pre market approval tool, as well as protecting trade secrets. The stipulations are:
- Unwavering language that FDA may neither reject a submission nor create qualifications on submissions that would permit the agency to reject a listing
- Protections for confidential or proprietary business information from public release
- Limits on the information provided to FDA to those items that appear on the label
- No creation of broad, new prohibited acts, which could have unintended consequences for the industry.