We recently learned that inaccurate and misleading reporting language had been included in an appropriation bill in the United States House of Representatives. Fortunately, the language of the report does not have the force of law, but it was still a bad surprise.
The language reflected some proposals from anti-supplement groups like The Pew Charitable Trusts and said: “[The] The Committee is concerned about the lack of strong regulation of dietary supplements, some of which cause an estimated 23,000 emergency room visits per year, including fatal illnesses and deaths, and encourages the FDA to issue regulations requiring mandatory listing and registration of food supplements. products to create transparency in the supply chain.
Eh? A member of the credit committee clearly did not do his homework, as this estimate was part of a study published in the New England Journal of Medicine, which the Natural Products Association (NPA) criticized for its flawed methodology and conclusions. .
But what does “encourage” mean and should we be concerned? This means that the language of the report is not exactly at the top of the priority list. So aside from the bad reputation, which we’re not happy with, the possibility of Congress adopting new requirements for the dietary supplement industry seems slim, doesn’t it? Wrong.
Next come the Senate officials. Powerful and long-standing industry critics like Sense. Richard Durbin (D-Illinois) and Patrick Leahy (D-Vermont) are used to proposing wrong legislation when it comes to nutritional supplements. As a general rule, rights holders should not give new legal permissions to fund the government. But given the pro-regulatory stance of the Biden administration, it’s not surprising to see this backhanded approach of heavier and unnecessary rules.
What is surprising is that the Biden administration is effectively duplicating a proposal from the previous Trump administration, which has been repeatedly criticized by the current administration. The surprises don’t end there. While some in the industry support yet another product registry – in addition to the current dietary supplement product label databases – we hope they never signed up for a partner in this business – Pew – to describe the industry as life threatening.
Why? When you search for “Pew” and “Supplements”, you find the exact same language as the credits report titled “Stricter monitoring of dietary supplements is still needed to protect consumers.“
Pew and others argued for a mandatory product registry, but failed to provide industry leaders with any evidence that it would have a significant impact on public health. During this time, the FDA does not enforce the laws and regulations already in force. Pew has said for years, “At a minimum, supplement manufacturers should be required to provide the FDA with basic information such as the product name, ingredients, and label for every product sold… Known as list, this requirement would increase transparency and strengthen the FDA’s ability to respond to emerging concerns. But the FDA already has access to this information through various resources and tools, such as the National Institutes of Health (NIH) Dietary Supplement Label Database. Yet the FDA does not use this resource and many others.
It’s no secret that groups like Pew and others have been attacking the industry for years. They have tried and failed to over-regulate dietary supplements. The difference this time is that it is politically convenient for the current administration to graft on and support a heavy policy initiated by groups like Pew during the previous administration.
Did the people in the industry really think that making an alliance with a group that just wants to see the industry go away would result in a partner or a process that they could control?
We advise Congress that instead of questioning the undisputed record of the safety of nutritional supplements used by two-thirds of all Americans, the FDA should focus on the following: using its enforcement powers to set a safe level of consumption for CBD; perform more facility inspections; and step up efforts to enforce the New Food Ingredient Notification (NDIN) requirement in law, particularly with respect to imports.
And there are more surprises. As Natural Products Insider so aptly described in a recent series, the FDA says a lack of resources limits its ability to enforce the NDIN requirement at U.S. borders. Some resources may have been diverted from inspections due to COVID-19 concerns, but we still haven’t seen a funding proposal to bring inspections back to pre-COVID levels, improve much-needed foreign inspections, or fill in. shortcomings in the enforcement of NDIs imported into the United States and not meeting FDA requirements. This despite the fact that pre-COVID inspections were significantly lower than 5 or 10 years ago, even with years of increased funding. Is it a sincere effort to use existing laws to protect Americans? Is this an effort to effectively regulate the industry? As a former director of the Food Supplement Programs Division of the FDA, I can attest to the fact that the system is working effectively, provided the requisite will is applied.
While the FDA will likely receive more funding, the agency should be held accountable. Otherwise, the FDA will continue to be a stubborn and stagnant agency more focused on acquiring new authorities than using the tools it already has.
Some voices claiming to represent the best interests of the industry have to let go of their obsession with the new legislation, just so they can say they’ve done something. Instead, we should use the process to ensure that the FDA, as the regulator, inspects more facilities in accordance with current good manufacturing practices (cGMP) and enforces the NDIN requirement, especially against imported NDIs. in our country. These are not difficult concepts. It is common sense.
If children were given a larger allowance for skipping their household chores, people would question that parent’s logic. The same is true here. We have to be very careful about signing short-sighted proposals and rewarding bad behavior. This is especially true when you consider the huge role supplements played during the pandemic and the growing popularity of natural products in health and wellness.
Daniel Manufacturer, Ph.D., is CEO and President of the Natural Products Association. He was previously the director of the FDA’s (now “Office”) division of dietary supplement programs.