At a time when presidential candidates are being asked which federal agency needs to be cut out due to excessive spending, bureaucratic red-tape and regulations from here to Timbuktu, a bill was recently introduced by Senator Dick Durbin (D-IL) which aims to expand the Food & Drug Administration’s reach, further encroaching upon the dietary supplement industry with incessant regulations. Senate Bill 1310 has been referred to the Committee on Health, Education, Labor and Pensions which, dare I say, should certainly have more important things to discuss right now then dietary supplements…
Although, according to a study funded by the Natural Products Foundation, the dietary supplement industry contributes more than $60 billion to our national economy which is nearly triple U.S. consumer sales. Perhaps this committee should be looking for ways to stimulate this economic driver, rather than looking into putting a stranglehold on the industry. Not only does the dietary supplement industry clearly have a market, they are also creating and supporting jobs in a myriad of industries in addition to their own such as manufacturing, retail sales & scientific, among others. There is obviously a large percentage of Americans exercising their right to health freedom and supporting the dietary supplement industry, Sen. Durbin should take heed with his attack.
You might be wondering, why the need for additional government intervention? I know I am. This bill will lead to restricted access to products that Americans are choosing to buy & raise the cost to the consumer for these products ultimately stifling competition within the industry. I can’t help but wonder, is Big Pharma behind this bill? Interestingly enough, the same day that SB 1310 was introduced, the FDA issued, “Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” which just so happens to contain the same elements outlined in Durbin’s bill.
Durbin’s bill would require additional labeling on dietary supplements that in the past have been labeled simply a food or a beverage. Surprise, surprise – this new labeling triggers massive regulations! The dietary supplement companies would have to go through a lengthy registration process for each of their products with the FDA which requires more money, time and resources. This is an issue that Sen. Durbin has brought up numerous times in the past and it appears to be an attempt to address his need for a clearer FDA definition of a “conventional food” – a long standing issue within the industry. The reason that this debate is important is that there are different safety regulations for “conventional food” and “dietary supplements” regulated under the Dietary Supplement Health and Education Act (DSHEA). Although DSHEA called for this definition when it passed in 1994, the bureaucrats at the FDA have failed to do their job and the debate over this definition has been raging for the past 17 years. Durbin’s bill puts the weight of what should be the FDA’s burden, squarely onto the shoulders of the dietary supplement manufacturers. The biggest kicker of all is that there are already numerous regulations and laws in place that are not being enforced which would address his stated concerns. There are also several practices which are industry standards put in place for the consumers’ safety like using product lot numbers.
If you think about it logically, it is in the industry’s best interest to produce a safe, effective product so that they can maintain a profit – this legislative attack will do nothing to make these products safer, it will only suffocate the ability of the smaller producers to maintain their place in the industry eventually stifling competition industry-wide. Even the Association of American Physicans and Surgeons is oppossed to this bill.
The president and CEO of the Council for Responsible Nutrition (CRN), Steve Mister called the bill, “a misguided bill that doesn’t address the concerns raised by Sen. Durbin, but instead creates more bureaucracy for an already resource-challenged agency and more red tape and costs for industry while doing nothing to further protect consumers from his concerns. Instead of urging FDA to use its current enforcement authority to isolate and punish those companies that are not following the law, this bill serves to punish all responsible companies with its overreaching mandates.”
In addition to registering their product with the FDA, the companies that manufacture these supplements would also have to register their facility; a description of each dietary supplement product manufactured by that facility; a list of all the ingredients in each of those products; a copy of the label and labeling for each of those products. And then, if a product is reformulated or discontinued, the bill also mandates that this registration process start all over again & be done within 30 days of beginning manufacturing, reformulating or discontinuing a product. Adding to the red tape, SB 1310 would require that the FDA create a list of all possible adverse side effects to groups like pregnant women or children; engage with the Institute of Medicine to evaluate the ingredients and proprietary blends within 18 months and produce a report on its findings; the report would be followed up with a public comment period and 2 years later, the FDA would be required to publically identify what they feel to be dangerous to the public.
Under DSHEA, a dietary supplement is defined as: a vitamin, a mineral, an herb or botanical (excluding tobacco), an amino acid, a concentrate, metabolite, constituent, extract, or combination of any of the above. Additionally, it must also be intended for ingestion (pill, capsule, tablet, powder or liquid); not represented for use as a conventional food; and labeled as a dietary supplement.
What do all of Durbin’s proposed regulations boil down to? Essentially, a transparent attempt to have vitamins and dietary supplements treated like drugs which will not go over well with the over 150 million Americans who make the choice to purchase these products annually. I support health freedom. I support free markets. I support an individual’s right to choose to purchase whatever product they want and Sen. Durbin’s SB 1310 is a blatant attack on that right. If you agree, please join me in opposition to Senate Bill 1310.