The revised AMA policy was adopted earlier this month and was announced to the public via a press release yesterday.
“We need the federal government to step up its regulation and enforcement of the dietary supplement industry to remove unsafe products from the market and protect public health,” said outgoing AMA board chair Dr. Jesse M. Ehrenfeld, MD.
Specific AMA recommendations
The new AMA policy calls for:
- Efforts to enhance FDA resources, particularly to the Office of Dietary Supplement Programs, to appropriately oversee the growing dietary supplement sector and adequately increase inspections of dietary supplement manufacturing facilities.
- FDA having appropriate enforcement tools and policies related to dietary supplements, which may include mandatory recall and related authorities over products that are marketed as dietary supplements but contain drugs or drug analogues, the utilization of risk-based inspections for dietary supplement manufacturing facilities, and the strengthening of adverse event reporting systems.
- Continued research related to the efficacy, safety, and long-term effects of dietary supplement products.
The new policy, which extensively references papers coauthored by noted industry critic Dr. Pieter Cohen, MD, of the Harvard Medical School, calls for FDA to mandate that supplements be required to conform to USP standards for identity, strength, quality, purity, packaging and labeling. The policy also recommends that FDA institute a mandatory product listing and that the Agency modify the New Dietary Ingredient provision to encourage more NDI filings.
Agreement with some of new policy
Industry stakeholders found much to agree with in AMA’s stance.
“Today’s American Medical Association (AMA) call for more stringent regulation and more FDA enforcement has many parallels to calls from the supplement industry – including members of the Consumer Healthcare Product Association (CHPA) – who believe DSHEA needs to be modernized and strengthened,” said John Troup, PhD, vice president of scientific affairs at CHPA.
Some AMA suggestions already circuating in industry
Steve Mister, president and CEO of the Council for Responsible Nutrition, echoed that concilatory tone. Mister noted that some of the things AMA was calling for were initiatives put forward by CRN itself.
“Like CRN, the AMA’s new policy statement calls for increased enforcement of the current law, the removal of unsafe products from the market, and truthful labeling of products. The AMA statement shares CRN’s strong support for establishing a mandatory product listing for supplements, improving label literacy to help consumers better understand the products they take, and for open-minded, better-informed dialogues between healthcare practitioners and their patients about supplement usage,” Mister said.
One issue where CRN differed with the new AMA policy was in the matter of proprietary blends, which the AMA was calling for to be abolished. Mister noted that propriety blends are in fact required to list their ingreidents; only the amounts are held as a trade secret.
“That allowance protects unique product formulations from copycats and is one of the few aspects of the law that guards innovative advancements by product formulators,” Mister said.
NPA: AMA ignores stellar safety record
Dan Fabricant, PhD, president and CEO of the Natural Prdoucts Association, took a harder line.
“We agree with their statement on enforcement. In terms of the rules, though, we couldn’t disagree with them more,” he said.
Fabricant said NPA has encouraged physicians to engage more with the adverse event reporting system. An NPA statement on the new AMA policy notes that dietary supplements as a whole have extremely low adverse event reporting rates making them safer by that standard than are drugs or even conventional foods.
“Granted, there is no substitute for a healthy diet, exercise and good choices, and people should always speak to their doctor before deciding to take a supplement. But the truth is that few of us get enough nutrients from food alone and nutritional supplements are essential to millions of Americans who use them each and every day to support their health,” Fabricant said.
NOW, leader in finding quality problems, weighs in
Supplement manufacturer NOW, based in Bloomingdale, IL, has taken a lead this year in identifying poor quality supplements being sold online. NOW has tested batches of SAMe, CoQ10, acetyl-l-carnitine, phosphatidylserine and ALA products with generally poor results, finding a majority of the products were understrength. But Aaron Secrist, Executive Vice President of Quality, R&D and Operations at NOW Health Group, said those results shouldn’t be used to impugn the many solid manufacturers in the industry, and said his company was in agreement with some of the points AMA has made.
Secrist noted that leading industry companies along with NPA stepped up to create a GMP certification program even before FDA got around to issuing the regulation. And he said the industry has banded together to create the Supplement Safety & Compliance Initiative (SSCI).
“We believe that DSHEA provides a robust regulatory framework to regulate the dietary supplement industry. Historically, the problem has been the lack of enforcement by the FDA,” Secrist said.
“The proliferation of the e-commerce platform has helped the dietary supplement industry to explode in the last decade. This has made the traditional barriers to entry very low for unscrupulous dietary supplement companies. There are some brands that have sprung up overnight and become very popular on Amazon and other e-tailer sites that nobody in the responsible industry has ever heard of. This issue is not specific to the dietary supplement industry. NOW Foods has been very instrumental in calling out these fraudulent brands by testing them and publishing the results in the trade press and on the company’s website,” he added.