Q. What is the purpose of HR 3380?
A. HR 3380 amends the DSHEA law and seeks to dramatically limit future FDA authority to regulate supplements like drugs by using the DSHEA law itself against the FDA.
A. For seventeen years the FDA has engaged in its salami-slice strategies to blame industry and penalize supplement consumers via administrative regulations and industry guidelines. HR 3380 is a proactive response to the FDA’s continuing efforts to subvert the intent and the letter of the 1994 DSHEA law.
Q. What would HR 3380 do?
A. HR 3380 exempts approximately 25,000 dietary supplements that have already been FDA reviewed and approved for sale under DSHEA between January of 1995 and January 2007, according to industry statistics. The CDC estimates that supplements are now used by at least 53% of Americans on a daily basis.
A. DSHEA “exempted” supplements sold prior to 1994 from the regulatory requirements established by DSHEA. These supplements were “grandfathered” into law and classified as being “Generally Recognized As Safe” (GRAS) products for public consumption; placing them outside of FDA regulatory overreach.
Q. What is “Grandfathering” and why is this important?
A. HR 3380 simply updates the “grandfather date” in DSHEA from 1994 to 2007. Supplements were “grandfathered” because DSHEA did not exist and no FDA documented record of safety existed. Many thousands of GRAS supplements would be exempt from future FDA regulatory actions by moving the date forward; and there is now 17 years of historical consumer use safety data to support this.
Q. What is the reason for the January 2007 date?
A. The date links exempted dietary supplement status with two existing FDA supplement laws. The DSHEA mandated Good Manufacturing Practices (GMP) industry guidelines, to ensure the safe production of supplements, were implemented in 2007. The Dietary Supplement Adverse Event Reporting law, a post-market safety monitoring system, was implemented in 2007. Any other date would be a repeated arbitrary decision, as was the case in 1994, making it less defensible to DSHEA opponents.
Q. What is the position of other groups on HR 3380?
A. For the time being, the industry associations are not taking a position. They wish to give the FDA the opportunity to withdraw the FDA proposed NDI Guidance, or to negotiate for years with the FDA. The DSHEA FDA regulatory history shows that this is a waste of time and has not benefited consumers.
Between the remaining legislative or judicial avenues, the NHF believes the legislative course is best. The goal is to eliminate the FDA’s ability to continue to impose its anti-supplement agenda by closing the size of the window to which it can be imposed in the future. HR 3380 accomplishes this and should be supported by health freedom advocates and supplement users.