Freedom Caucus Hit List Includes Antibacterial Soap, Supplement Label Rules
This article was originally published in The Rose Sheet
Executive Summary
The caucus of 36 conservative Republicans lists 200 rules passed during the Obama administration, or the that president established through executive orders, that it recommends striking altogether or changing to lessen industries' regulatory burden.
Rules on consumer antibacterial soap ingredients and dietary supplement labeling are on a 23-page list of regulations the House Freedom Caucus wants eliminated in the first 100 days for the Trump administration.
The caucus of 36 conservative Republicans cast a net far and wide in listing 200 rules federal agencies have passed during the eight-year administration of President Obama, or the president established through executive orders, that it recommends striking altogether or changing to lessen industries' regulatory burden.
FDA, Centers for Medicaid and Medicare Services and other Department of Health and Human Services agencies account for 52 of the total count. Another source of regulations Republicans frequently criticize, the Department of Education, accounts for 26 of the regulations the caucus members ask President-elect Donald Trump to eliminate or change soon after his Jan. 20 inauguration.
The caucus chairman, Rep. Mark Meadows, NC, published the list on Dec. 14 along with a statement on Trump's election to the White House and the continuing Republican majorities in the House and Senate.
Republicans have "an opportunity to restore order in our government and to remove the out-of-control bureaucratic red tape that so often stunts the growth of otherwise successful Americans," said Meadows, who was re-elected to his third term in November and earlier in December was elected caucus chair, replacing Ohio Rep. Jim Jordan, who retired.
Rinse Away Soap Rule
A final rule FDA published in September put a one-year deadline on removing from consumer antibacterial soaps and body washes triclosan and 18 other ingredients commonly used in the products. (Also see "FDA: ‘Vast Majority’ Of Antibac Soaps Need Reformulation Under Final Rule" - HBW Insight, 2 Sep, 2016.)
The agency's Center for Drug Evaluation and Research acknowledged that most products in the categories available in the US contain at least one of the ingredients that were determined not to generally recognized and safe and effective, making them ineligible for OTC drug monograph listing.
The Freedom Caucus recommends rescinding the rule with a succinct statement why: the list's "Cost Of Rule" column says $106.3m to $402.8m.
The caucus also states the same sums as its reason for recommending cancellation of FDA's related proposed rule to amend the tentative final monograph for consumer antiseptic products intended for use without water by establishing conditions under which formulations are GRASE.
The June proposal gave firms one year to submit data showing that ethyl alcohol, isopropyl alcohol and benzalkonium chloride used in consumer antiseptic rubs are GRASE to ensure that they can continue marketing the products. With the proposals, FDA separated antiseptic rubs as a subcategory under the TFM. (Also see "The 'Rub' On Leave-On Consumer Antiseptics: FDA Seeks Safety, Efficacy Data" - HBW Insight, 20 Jul, 2016.)
Labels, FSMA, Deeming
The caucus offers more on its reason for recommending elimination of FDA's May final rule on revising labeling for Nutrition and Supplement Facts Labels. (Also see "'Landmine' Of Consequences In Nutrition, Supplement Facts Label Changes" - HBW Insight, 22 Jul, 2016.)
The rule, with compliance deadlines of June 2018 or 2019 depending on a firm's size, is estimated to have "costs ranging between" $200,000, $500,000 and $800,000, according to the list.
Additionally, the caucus points out the "rule places regulations on the serving sizes of breath mints."
The group also asks the Trump administration to strike some FDA regulations required by the Food Safety Modernization Act. On its list, the caucus notes that FSMA regulations include the "Mitigation Strategies To Protect Food Against Intentional Adulteration" final rule published in May with aims including preventing "acts of terrorism targeting the food supply” and total costs for compliance with the rules ranges between $280m and $490m annually. (Also see "Foreign Supplier Verification Concerns Grow On Supplement Firms" - HBW Insight, 16 Sep, 2016.)
Another FDA regulation the caucus recommends for elimination is in the rule the agency published in May that adds to the agency's tobacco manufacturing oversight electronic nicotine-delivery devices and liquids as well as cigars, pipe tobacco and other tobacco products not already regulated. (Also see "FDA Rule Stifles E-Cigarettes' Harm Reduction Role With Grandfather Date, Application Costs" - Pink Sheet, 12 May, 2016.)
The caucus published its list a month after the House Republican leadership warned federal agencies against publishing more regulations before the end of President Obama's term. The members' request tracks with the Trump's campaign priority for trimming federal regulations. (Also see "GOP Request To Stall New Rules: Post-Election Business As Usual On Capitol Hill" - HBW Insight, 28 Nov, 2016.)
However, while a White House moving toward less stringent regulations would be welcome for the supplement industry, potentially restrictive foreign trade policies Trump appears to favor could be a setback. (Also see "Trump Administration May Relax Supplement Industry Oversight, But Heighten Trade Concerns" - HBW Insight, 10 Nov, 2016.)