US Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) recently introduced the Durbin-Blumenthal Dietary Supplement Labeling Act. This legislation is intended to protect consumers from dangerous supplements by imposing new requirements on supplement manufacturers. While the intentions of this legislation are noble, there are fatal flaws that will prevent this bill from accomplishing any of its goals.
There are 4 main objectives of the bill, and what follows is the corresponding 4 reasons why this bill won’t work:
The 4 Objectives of the D-B Supplement Labeling Bill (scroll to the bottom of the page)
Requirement #1: Allowing FDA to track how many dietary supplements are on the market and what ingredients they contain.
Flaw #1: A registration requirement is only as effective as the person/people reviewing the submissions.
The proposed legislation would require dietary supplement manufacturers to register their products with the FDA and to provide a copy of the label as well as information on its ingredients (to prove safety and efficacy).
Theoretically, that would curtail the number of products that are absolute poppycock, with no scientific basis whatsoever. Example: Deer Antler pills (no, this is not a joke).
In reality, it will take a live human being to read through all the paperwork (electronic or hard copy) of all the dietary supplement registration/submissions. And if said FDA Agent finds something bogus, won’t it require another human being (or multiple people) to call or visit this dietary supplement manufacturer and deliver the warning letter or Cease and Desist notification?
With human resources and manpower already stretched thin, how will the FDA accomplish any of the supplement review goals stipulated in this bill?
Requirement #2: Requiring more information on product labels including warnings associated with specific ingredients.
Flaw #2: This requirement means supplement manufacturers would have to put warnings on the label to call out the hazards for specific ingredients that may cause adverse events for any particular groups. Hmmm, now that sounds like a fantastic idea…but does this sound familiar to anyone else?
Furthermore, the Council for Responsible Nutrition brought up an excellent point in their official response to the proposed bill. As Steve Mister, President and CEO, CRN said in the statement,
We cannot support legislation that directs FDA to require warning labels for products or ingredients that ‘could cause’ adverse events or potential risks as this is a case of the precautionary principle run amok. While the premise may be well intentioned, in practice this requirement would lead to confusing and unnecessary label instructions likely to deter consumers from using beneficial dietary supplements based on uncommon or miniscule risks. Further, a new law is unnecessary because the Dietary Supplement Health & Education Act (DSHEA) already provides FDA with the authority to mandate warning labels if the agency determines there is an unreasonable risk of injury or illness under the conditions of use provided in the labeling. Other provisions of the legislation likewise create burdensome new mandates for manufacturers who are already complying with DSHEA without addressing the industry’s outliers.
Requirement #3: Giving FDA the authority to require manufacturers to provide proof for any potential health benefit claims
Flaw #3: Current law already requires a supplement manufacturer to notify the FDA about their structure/function claims (meaning claims that an ingredient with a particular structure elicits a particular function – ex. Calcium builds strong bones).
One point for the bill: According to this article by Natural Product Insider, a government report has indicated that the FDA needs more authority to compel a manufacturer to submit these kind of documents to prove their structure/function claims.
HOWEVER: When the FDA is granted more authority to monitor these claims, the argument of Insufficient Manpower comes up again. What good is having the authority to monitor and request these documents if there aren’t actual people and hours to devote to this task? It would be a tough call to have to decide whether to put FDA’s resources toward monitoring supplement claims and monitoring imported foods and resolving food outbreaks (Remember the Cantaloupe Crisis? The Deadly Peanut Butter Salmonella outbreak?) FDA Resources Spread Thin in Enforcing Food Safety
Requirement #4: Directing the FDA to clarify the distinction between dietary supplements and food and beverage products with additives.
Flaw #4: Beverages are not inherently safer than supplements.
It’s no secret that Senators Durbin and Blumenthal are anti-energy drinks.
Oddly enough, one of the biggest complaints against energy drinks is that they are beverages masquerading as supplements. Supposedly, that makes them less accountable for ensuring product safety. As laid out clearly in this article by The Hill Regulation Blog:
“Energy drinks are marketed as dietary supplements instead of beverages, leading them to be regulated more laxly, Senate Democratic Whip Dick Durbin (Ill.) said.”
HOWEVER, as food/beverage/supplement industry lawyer Justin J. Prochnow explains in this interview from BevNet Live, (starting around 3 minute mark) switching from a supplement to a beverage doesn’t mean the product is safer. It means the product has to abide by a different set of rules (What? Supplements have regulations? Yes, and this is the #1 myth regarding supplements because indeed, they DO have regulations to abide by).
Monster energy, Red Bull and Rockstar are now all marketed as beverages (actually, Red Bull has ALWAYS been marketed as a beverage). Does that mean these products are any less likely to harm someone who consumes too many energy drinks in one day or consumes just one energy drink too fast (meaning consuming over 200mg caffeine under 20minutes)? No.
The bottom line is regardless of whether the product is marketed as a food/beverage/supplement, there are multiple other factors that determine its safety.
BOTTOM LINE: Those in the supplement AND food industry know safety is multi-factorial. Hygiene, pest control, ingredient contamination and adulteration – all these factors and many more affect how safe a product truly is. In a world where a supplement or food company can easily falsify a piece of paper stating the composition of their product, the answer is NOT to require companies to file more paperwork. The answer is not to give the FDA and other governing bodies the authority to monitor that paperwork, but to give them the resources (money, manpower, hours, grassroots support etc) to enforce the laws and regulations already in existence.