Dietary Supplements Update: October 2, 2013
Just as Congress was leaving Washington for their August recess, Senator Durbin Launched and Richard Blumenthal (D-CT) introduced S. 1425, The Dietary Supplement Labeling Act of 2013. This legislation is the latest attempt to undo the Dietary Supplement Health and Education Act of 1994 (DSHEA) and nudge dietary supplement regulations closer to the drug regulatory model. We cannot let this happen as it will only serve to reduce access to products and drive the cost of products higher!
In an orchestrated legislative-media 1-2-3 punch, (1) USA Today posted a story regarding Matt Cahill, the developer of several designer steroids marketed as dietary supplements. (2) On July 30, Senator Durbin gave an impassioned speech on the Senate floor to reference the USA Today paper, in which he promotes the perception that the FDA conducts tests on drugs and should conduct tests on supplements. This inaccurate on its face and shows his long standing intention that supplements be removed from food regulations and forced into drug regulations. (3) On July 31, Senator Jay Rockefeller (D-WV), Chairman of the Committee on Commerce, Science, and Transportation gave Senator Durbin a forum in a hearing entitled, “Energy Drinks, Exploring Concerns About Marketing to Youth.” to raise an alarm about supplements and to open the door for the introduction of his revised legislation.
S. 1425 – The Dietary Supplement Labeling Act of 2013 would:
- Add an additional level or registration requirements over and above the facility registration requirements of all foods implemented through the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- Add an additional level of reporting of product labels to include a list of all ingredients which will be made public. Keep in mind:
- Proprietary data will not be protected, thus opening the door for companies to suffer significant financial losses from copy-cats.
- A database of dietary supplement labels already exists and is available to the public through the National Institutes of Health’s Office of Dietary Supplements at: http://www.dsld.nlm.nih.gov/dsld.
- Development of mandatory warning labels for dietary supplements for which the government determines may cause potentially serious adverse events, drug interactions or contraindications, and potential risks to subgroups such as children and pregnant women.
- Additional label requirements for proprietary blend products.
- Have the FDA create a list of dietary ingredients and propriety blends to target for ‘warning labels’ and use the Institute of Medicine (IOM) to make regulatory decisions based on the possibility of adverse event rather than actual reports of adverse events.
- Change the substantiation process for dietary supplement structure function claims to open the door for pre-market approval.
- Require the FDA to establish a definition for “conventional foods” (presumably to target energy drinks and other products that are not in capsule/pill form.)
S.1425 Is Not Needed! The suggested additional layer of regulations in this Bill will be costly; will open the door for companies to have their products copied because natural products typically do not have the same patent protections as drugs, and will nudge supplements out of the food category and into the drug category by opening the door for required pre-market approval. Furthermore, a registry of labels already exists within the government and many companies already include on the label information to advice about pediatric and pregnancy use.
What Can You Do? Click here to register your opinion on S. 1425. Click here to take survey. Share this link with everyone you know who cares about dietary supplement access.