Reports from Washington sources indicate that Illinois Democrat Senator Dick Durbin is scheduled to introduce the Dietary Supplement Labeling Act, in, according to Durbin, "an effort to improve information to consumers." However, perhaps seeing this as merely a ploy to enable the U.S. to follow similar anti-vitamin legislation in the EU, some industry associations are calling for more enforcement of the existing volume of regulations and not additional legislation.
According to a release from Durbin's office, the bill would: direct the Food and Drug Administration (FDA) to define "conventional foods," require manufacturers to register dietary supplement products with the FDA, require labels to disclose the known risks of ingredients, and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events.
The bill also calls for labels to display the batch number, which is something already adopted as standard industry practice.
"My goal is to take the decision about how a product will be regulated out of the hands of the manufacturer and put it in the hands of the FDA where it belongs," said Durbin. "Consumers who don't scour the fine print on the back of products may never know the difference, but they will be safer as a result of this bill."
Commenting on the details of the release, Michael McGuffin, president of the American Herbal Products Association (AHPA), described the bill as "largely proposing legislative solutions where what is needed is regulatory enforcement." "Supplements may not be represented as conventional foods and must be labeled to include all information -- including safety information -- that is, material in light of the consequences that may result from their use. And while no one will argue with the wisdom of using product lot numbers, it is already the standard industry practice to do so."
AHPA added that the most controversial part of the Dietary Supplement Labeling Act may well be its requirement for product registration: This is exactly what the EU anti-vitamin, herb and traditional medicines legislation calls for, and Sen. Durbin has sought such a change in the past.
"AHPA is in communication with Sen. Durbin's office, and I will be reviewing the actual legislation as soon as it is available," added McGuffin. "As always, AHPA's primary focus will be on identifying and opposing any legislation that in any way reduces consumer access to safe dietary supplements," McGuffin also noted.
Cara Welch, PhD, Vice President of regulatory & scientific affairs for the Natural Products Association (NPA), told NutraIngredients-USA that without having seen the language of the bill, based on his [Durbin's] release, there were "some areas where Sen. Durbin has a point, like the clarification of conventional foods -- we've been awaiting this for a number of years -- while there are sections we don't like." "What we don't want to see is new sweeping regulations against the kind of health aids that Sen. Durbin says he takes everyday," she said.
Harry Rice, PhD, director of regulatory & scientific affairs for the United Natural Products Alliance (UNPA), questioned the timing of the legislation. "Given that the New Dietary Ingredient (NDI) guidance is due to be published this Friday, the timing of the introduction of this legislation is nothing short of deliberate," said Dr. Rice. "This legislation reeks of Senator Durbin's longstanding opposition to DSHEA and is likely meant to rattle and erode the public's faith in dietary supplements."
Dr. Rice added that the statement that dietary supplement manufacturers do not have to prove the safety of their products before selling to consumers was "simply not true". "Under DSHEA, a company is responsible for determining that the dietary supplement(s) it manufactures or distributes is safe," he added.
Jonathan Emord of the Virginia-based law firm, Emord & Associates, said the bill was a "classic example of regulatory overkill." "The FDA has full regulatory power to prevent the sale of adulterated and misbranded foods and dietary supplements. Something consumed primarily for its taste in the normal daily diet is a food and must satisfy the food additive provisions of the Act."
"A dietary supplement is, by definition, a supplement to the daily diet, not substitutable for a food in common form. The agency routinely makes these distinctions and needs no additional power. By introducing new powers when old ones are more than sufficient, he invites abuses, including more burden and cost on an industry that is already overwhelmed by the burden and cost of the Good Manufacturing Practices (GMPs) and now, the Food Safety Modernization Act," added Emord.
The release from Sen. Durbin's office focuses predominantly on products in food or beverage forms, such as energy beverages. Durbin describes products like Rockstar Energy Drink and 5-Hour Energy as "foods and beverages taking advantage of the less stringent safety standards for dietary supplements under current law".
However, Jonathan Emord noted that the "FDA has had pending, since 2009, a rulemaking to distinguish between beverages and dietary supplements -- proof that it has the power and is at work on the very issue Durbin redundantly addresses.
Sen. Durbin said that his goal "is to take the decision about how a product will be regulated out of the hands of the manufacturer and put it in the hands of the FDA where it belongs."
We believe that, due to the stringent existing regulations that natural health manufacturers already have to deal with, the effort to create more legislation, especially legislation that parallels the European anti-vitamin, herb and traditional medicines legislation, is simply an effort to move the natural health industry forward in harmonization with EU laws and eventually under the purview of the pharmaceutical industry. Ironically, the natural health industry already has manufacturing and processing regulations parallel to the drug industry.
Efforts to medicalize natural health products can do no good in the short, medium or long term. Economically, it will result in significant increases in costs and reduced availability. Consumer safety concerns are ironic in that the natural health industry maintains a stellar record, whereas the pharmaceutical industry does not as we have continually reported throughout the years.
We will keep you updated on this issue and what you can do to help appropriately resolve it.
All the best,
Rudi C. Loehwing
World Institute of Natural Health Sciences