Michael D. Levin, Health Business Strategies
February, 2010

Michael Levin

The Dietary Supplement Safety Act of 2010, a bill proposed by Senators McCain and Dorgan, has been referred to the Committee on Health, Education, Labor and Pensions. The details of this bill and the committee members can be found here.

While the stated intent is to “more effectively regulate dietary supplements that may pose safety risks unknown to consumers,” this bill is an excellent example of well-intentioned legislation failing miserably to achieve its purported goals, leaving in its wake an expensive regulatory burden for both FDA and industry. Worse, it puts safe and valuable dietary ingredients at risk of being removed from the market.

Key provisions include:

1) An company which “manufactures, packages, holds, distributes, labels or licenses a dietary supplement” must register with the FDA and submit a copy of all “labeling” for all “dietary supplements” it handles, along with a “full list of the ingredients contained in each dietary supplement," which must be updated each and every year.

"This bill is an excellent example of well-intentioned legislation failing miserably to achieve its purported goals, leaving in its wake an expensive regulatory burden."

2) Moreover, a “dietary supplement facility or retailer” shall “obtain adequate written evidence from the preceding responsible entity in the chain of commerce that the product is registered as required with FDA under this regulation.

3) All companies registering their products with FDA must “create and maintain a substantiation file relating to the claim that the dietary ingredient or dietary supplement will reasonably be expected to be safe…..the substantiation file shall be prepared and maintained in such form and manner as the Secretary may prescribe and shall be available for review and inspection by the Secretary upon request”.

4) New Dietary Ingredients (NDIs) as defined in DSHEA is gone. The NDI provision allowed for continued use of dietary ingredients provided they were in commerce prior to 10/15/94. Instead, this bill requires that the Secretary maintain a list of all “Accepted Dietary Ingredients”.  If an ingredient is not on the “Accepted Dietary Ingredients List”, it is “adulterated” and cannot be legally sold.

5) Serious Adverse Effect Reporting requirements are modified. The word “serious” is removed, thus requiring all companies to report all non-serious adverse effects to the FDA “accompanied by a copy of the label on or within the retail packaging of such dietary supplement”

	"Will consumers be better protected if 800 companies build a substantiation file for 500mg vitamin C tablets to be taken twice daily? I think not."

6) Recall Authority: The bill provides FDA with unprecedented sweeping recall authority in the event the product is “misbranded”, “adulterated”, or if the Secretary finds there is a reasonable probability that a “dietary supplement would cause serious, adverse health consequences or death”. If such a mandatory recall is ordered by the FDA, the responsible party has the option to notify FDA of its intent to challenge the recall and have a hearing, which must occur within 10 days of the initial order.

Assessment: With an announcement apparently timed to coincide with the Olympics, this bill was applauded by stakeholders in the US Anti-Doping Agency (USADA) and members of the Supplement Safety Now coalition.  These stakeholders rightly object to “designer steroids” – illegal substances – that render an athlete illegally “supercharged”, and the supplement illegally “adulterated”.

Is this bill likely to eliminate “designer steroids”? Not at all. Such adulteration is already illegal.

What might this bill cost? Let’s review:

1) Using conservative estimates, if the 1400 or so supplement companies each have an average of 30 products on the market, FDA will receive 1400 annual reports involving 42,000 products. Does FDA have the resources to build, review and maintain this database and prosecute non-compliance?

2) If each company uses an average of 100 unique dietary ingredients, the substantiation file requirements could be enormous. Looking at it from another perspective, if the average product has 3 ingredients, we would have 1400 companies building 126,000 substantiation records. Worse, in having each company responsible for their own substantiation records, and with many similar products being marketed by multiple companies, the redundancy would be staggering. Will consumers be better protected if 800 companies build a substantiation file for 500mg vitamin C tablets to be taken twice daily? I think not.

"This unprecedented recall authority, combined with a 'positive list of approved ingredients' is viewed as extremely worrisome for obvious reasons, especially by conspiracy theorists."

3) The real mystery questions are: What form of substantiation will satisfy the Secretary? And, how will the Secretary decide which dietary ingredients to add to the “Accepted Dietary Ingredients” list?  What happens to the ingredients that are overlooked? Under the bill, the Secretary would have the authority to issue a mandatory recall because the product is, technically, adulterated (i.e., the supplement contains an ingredient not on the Accepted Dietary Ingredients list). This unprecedented recall authority, combined with a “positive list of approved ingredients” is viewed as extremely worrisome for obvious reasons, especially by conspiracy theorists.

About Adverse Events, Serious and Otherwise: Of course, the mandatory reporting of all adverse events (not only serious adverse events, as now required under law), puts even more burden on FDA with no reasonably foreseeable upside for the public health. How much burden? If 1400 companies receive only 30 complaints of adverse effects/year, FDA would have to record (and presumably review) an additional 42,000 complaints annually (still a fraction of what they read from Pharma).

While immediate reporting of serious adverse events, as required under law, is both appropriate and necessary for protecting the public health, the reporting of clearly frivolous complaints associated with non-labeled use of a dietary supplement (eg, “my dog ate a bottle of your product and vomited”) is as much a waste of time as if food companies were required to report all adverse events. Food companies are not required to report all adverse events. If they were, the FDA would be pouring over complaints about little Johnny eating a gallon of ice cream and getting a tummy ache. I consider neither example a wise use of taxpayer dollars.

Adverse Events: The Bottom Line: FDA review of all adverse reactions associated with the use of drugs is appropriate and an essential part of post-marketing surveillance for all products intended to treat disease. FDA review of all adverse reactions associated with foods and dietary supplements – products intended to provide nutritional support -  is inappropriate. FDA review of all serious adverse reactions (defined below) associated with dietary supplements is currently required under current law and, from a public health and safety perspective, totally appropriate.

Serious Adverse Event – Current Legal Definition

Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or
Requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

	"I support [the FDA] vigorously prosecuting those found guilty of conspiracy to violate federal food drug and cosmetic laws by endangering the public health with illegal products."

The View From Here:  We unfortunately live in an age of anxiety and mistrust. The sad fact is this: every industry has a Bernie Madoff.  In the supplement industry, these a few “bad actors” who, in their greed, selfishness and disregard for the public, have not let their quest for cash be deterred by regulations. Instead of promulgating burdensome regulations that will do nothing meaningful to prevent adulteration, I support arming the FDA with the resources necessary to enforce existing regulations. I support their vigorously prosecuting those found guilty of conspiracy to violate federal food drug and cosmetic laws by endangering the public health with illegal products (be they foods, supplements or drugs). Sending a few to jail after seizing their assets and forever prohibiting them from ever returning to their industry just might serve to deter others from following their “yellow brick road”. If there’s a brick wall at the end of the brick road, others just might choose another path. Given the current state of enforcement where egregious offenses often only result in monetary fines, there is not a brick wall, only a toll booth. The most recent “toll booth” example can be viewed here.

Levin's Recommendation Levin proposes legislation which goes to the source - requiring the laboratories that would first discover adulterants to immediately report them.

Alternatives? And if we cannot rely upon enforcement of current regulations to protect the public health and feel compelled to commit taxpayer dollars to new regulation, logic suggests that we take a cue from US Customs. How? Protecting our food supply by detection of adulterants at the point of entry is, arguably, the logical place to start. Where are dangerous adulterants first detected? They are first detected at analytical laboratories who test raw materials and finished products. The lab: customer relationships are protected under client confidentiality agreements. Might it make sense to legislate a requirement for laboratories to immediately report to FDA the confirmed presence of dangerous economic adulterants in foods, dietary ingredients and dietary supplements?

Taking that step seems a more logical approach towards protecting the food supply and the public health.

Conclusion: Let’s let FDA enforce the current regulations, let them focus their limited resources on pursuing Big Issues (e.g, the GSK/Avandia increased heart attack risk issue) and, with this legislative alternative, have a new early warning tool by which to protect the food supply.

Meanwhile, S 3002 should be defeated quickly. To make your voice heard, please click here.