FDA PLANNING TO REGULATE SUPPLEMENTS

Astrid Riecken | The Washington Post | Getty Images
Scott Gottlieb, commissioner of the Food and Drug Administration (FDA).

FDA plans to overhaul oversight of $40 billion dietary supplement market, curb ‘potentially dangerous products’

The Food and Drug Administration plans to strengthen its oversight of the dietary supplement market in what Commissioner Scott Gottlieb called “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”

The agency is developing a new “rapid-response tool” to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients, the agency said in a press release Monday.

The dietary supplement industry is worth over $40 billion and the choices for consumers have skyrocketed from 4,000 products to 80,000 in the past 25 years, the agency said.

“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” said Gottlieb.

The agency is also looking to update its compliance policies with new dietary ingredient notifications, or NDIs, which requires manufacturers to alert the FDA of any ingredients that weren’t sold in the U.S. before 1994.

“An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” said Gottlieb.

It’s also creating the Botanical Safety Consortium, a partnership between the public and private sectors, to evaluate the safety of botanical ingredients and mixtures in supplements.

“This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders,” said Gottlieb.

It also is hoping to make enforcement processes easier, which allows employees to issue warnings to companies and consumers.

The FDA rolled out part of its plan Monday morning when it sent warning letters to 17 companies for “illegally selling” products that claim to treat Alzheimer’s disease.

“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” said Gottlieb. “To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products.”

The FDA said it will continue to roll out plans in the next few months and that it plans to open communication up to the public and stakeholders.

Article source: CNBC.com

OUR THOUGHTS ON THIS:

Pro: Based on the situation with supplements and many false health claims, we see this as a 50/50 good news, for there are certain supplements that meets the most strict guidelines within the FDA, and there are those who do everything in their power to cut corners and increase profits, thus putting the consumer’s health at risk. So whatever it takes to police the bad actors in the industry.

Con: On the contrary, we do NOT trust the FDA at all, so we’re very concerned about the FDA’s measure in dictating the practices of the supplements industry. Based on clear evidence, the FDA has been notoriously and infamously known to have nefarious agendas regarding pharmaceutical products, at the same time make decisions that further threaten and jeopardize the health of the public. They are bought and paid for by big pharmaceuticals, and just mentioning the term “stakeholders” gives us a disturbing hint that they’re ready, locked and loaded to protect the investments of their stakeholders…AKA…owners’…AKA medical industrial complex’s bottom line, profits and influence.

Nevertheless, we also know our market and the majority of our consumers, and trust their abilities to investigate, verify, research, and trust their instincts and intuition regarding ANYTHING they choose to invest in and consume in their bodies they feel is best for their overall health that does NOT need a stamp of approval of a sold out governmental special interest firm.

The bottom line? Our products and services already exceed the safety requirements and expectations that the FDA is looking forward to regulating. And although we believe the consumer should have the latest information on safety of ingredients they are putting in their bodies, depending solely on the FDA for your health decisions can sometimes be even more detrimental to your health. Just simply follow the money behind this move…and please be careful.

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