FDA is Broken

May 16, 2014 | Health Services

The Mission Statement posted on FDA’s Office of Regulatory Affairs webpage by Associate Commissioner Melinda Plaisier on Jan. 21, 2014, stated we can expect the agency to be “Protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.” The problem, however, is that when it comes to regulating dietary supplements, FDA appears to be utterly disinterested in protecting the public health or maximizing compliance. Simply put, the Agency’s actions—or rather inactions—suggest that FDA is broken.

The vast majority of companies in the supplement industry work hard to ensure they are in compliance. They invest significant resources—time and money—in working to implement cGMPs (current good manufacturing practices) and ensuring that their product labels and claims follow all applicable laws and regulations.

Sadly, there is an element that passes itself off as part of the supplement industry because it labels the products it sells as “dietary supplements” while displaying complete disregard for the law and consumer welfare. These companies do not know or care about GMPs and do not care what claims they make for their products or what they put in them. They sell pills spiked with undeclared active pharmaceutical ingredients or new dietary ingredients (NDIs), make product in facilities lacking even the most basic quality systems and claim to be able to cure cancer. They disregard regulations requiring notification of FDA before a NDI can be used, and they ignore letters from the agency advising that NDI Notifications are so defective that it is impossible to identify the ingredient and even hazard a guess whether that ingredient can reasonably be expected to be.

Mass media coverage makes it seem as if these scofflaws are the true face of the supplement industry. After all, it’s not news when a company follows the law and sells good, beneficial products; “male enhancement” products adulterated with sildenafil (Viagra) make for much more alarming (aka interesting) stories. Companies that provide this kind of news for the media make for even more interesting “news” because of the impunity with which they operate. The real news, however, should be FDA’s abject failure to use the multitude of enforcement tools (seizure, injunction, reinspection fees and even prosecution for strict criminal liability offenses) to make it clear that these scofflaws/criminals are not welcome in the supplement industry. Two recent examples illustrate how abysmally FDA is failing in its self-declared mission of “Protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.”

New Dietary Ingredients

On Nov. 15, 2013, I spoke at SupplySide West to address “Why We Asked for NDI Enforcement: Industry Integrity and Public Health.” At that time, I had already spent over a year working on behalf of clients selling the NDIs pyrroloquinoline quinone (PQQ), astaxanthin, and zinc carnosine. Each of these clients invested significant time and money in the extensive research necessary to demonstrate that their ingredients were safe for human consumption and that they were capable of manufacturing them consistently in a manner that did not create a public health risk. Each of them were also being victimized by competitors selling cheap knock-offs (euphemistically called “follow-on”) that couldn’t be bothered with niceties such as submitting the NDI notifications required by law, spending money on safety studies or ensuring their version of these ingredients didn’t contain heavy metals, unknown peaks (remember l-tryptophan?) or more than 40 times the upper acceptable limit of residual chloroform.

Starting in August 2012, we have repeatedly asked FDA to take action to stop the importation of these knock-off ingredients, citing the economic harm and potential public health risk created when NDIs are manufactured under unknown circumstances. We specifically stated our fears of a repeat of the l-tryptophan disaster of the late 1980s when at least 37 people died and nearly 1,500 were injured due to one company’s manufacturing error creating the presence of peak E in this ingredient.

In response to market pressure Mitsubishi Gas Chemical America was attempting to leverage in defense of its legally marketed PQQ, nearly a year after this situation was brought to FDA’s attention, on Aug. 29, 2013 Nascent Health Sciences LLC (Qingdao Nascent Trading Company LTD) finally submitted a NDI notification to FDA. On Oct. 29, 2013, FDA responded by advising Nascent that it has “significant concerns whether the dietary supplement product containing pyrroloquinoline quinone will be reasonably expected to be safe.” FDA’s letter specifically stated that it was “unable to establish the identity of your new dietary ingredient . . . based on the manufacturing information you provided” apparently because, we assume, complete manufacturing information would have disclosed that Nascent’s product was synthetic, which would have been immediately objectionable to FDA.

The letter also stated that the agency “was unable to establish the safety” of Nascent’s ingredient and raises questions about the appearance of lesions on the kidneys animals used in the studies cited in the notification. This letter was made public by FDA only after the submission of a Freedom of Information Act (FOIA) request. Despite receipt of this letter, Nascent continued to market its ingredient.

In the interim, on Oct. 21, 2013, Rep. Steve Stockman, (R-TX) wrote to FDA Commissioner Margaret Hamburg asking why the agency had failed to take action against NDIs marketed without the DSHEA required notification. Rep. Stockman’s letter specifically referenced PQQ, astaxanthin and zinc carnosine. Remarkably, FDA’s response on Jan. 16, 2014 asked the Congressman to provide it with the names of any companies he knew to be selling these ingredients without filing a NDI Notification, even though this information was already in its possession.

Coincidentally, during a meeting at FDA headquarters on Jan. 17, 2014, the agency was provided with specific evidence of continued marketing of Nascent’s synthetic PQQ. Materials relating to concerns regarding the presence of impurities in Nascent’s product were also delivered to the agency. Yet, three and half months later, Nascent continues to steal sales from Mitsubishi, and place product into consumers’ hands with no reliable evidence that it can be reasonably expected to be safe. FDA’s response to this has been to do nothing.

The situation with knock-off astaxanthin is remarkably similar. FDA has been aware for months that various companies have been selling synthetic astaxanthin for use in dietary supplements without bothering to file NDI Notifications. The reason is obvious: these notifications would be rejected by FDA since synthetic astaxanthin cannot be a dietary ingredient. (I lost that argument with FDA). Companies that chose to ignore the law in this manner have attempted to rationalize their behavior by claiming that their synthetic astaxanthin is “present in the food supply” because it is approved by FDA for use as a color additive in fish feed. Setting aside questions about how much of this synthetic color additive is actually consumed with a piece of fish, this claim ignores the statutory requirement that the substance be “present in the food supply as an article used for food in a form not chemically altered.”

Alarmingly, samples of synthetic astaxanthin from another supplier (whose product is not an approved fish feed color additive) have been tested by Fuji Health Science Inc. and been found to contain up to 24,000 ppm of chloroform; USP has set the maximum allowable amount of this toxin as solvent at 60 ppm. Finished product using this cheap synthetic knock-off have been found to be exposing consumers to between 1,910 and 4,660 ppm of chloroform, which is between 40 and 77 times the maximum allowable level. While it is incredibly discouraging that unethical buyers for supplement manufacturers will purchase this knock-off solely because of pricing, it is downright alarming that FDA has had this information for months and done nothing to remove this public health threat from the market.

Curing Cancer with no GMPs

On April 18, 2014 FDA issued a warning letter to Iowa Select Herbs. Sending such a letter is not unusual. Strikingly, however, this letter cited the company for making claims that its products cure “cancer to diabetes to constipation to heart conditions to arthritis …” The letter also cited an abject failure to comply with the cGMPs for dietary supplements noting violations ranging from failing ” to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement” to not bothering to conduct identity testing for dietary ingredients. The letter also noted the company failed to comply with even the most basic requirements for dietary supplement labels by failing to include a Supplement Facts Box.

Sadly, warning letters like this are not uncommon. It is inexplicable that 20 years after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), all FDA can muster against a rogue company preying on vulnerable consumers with serious illnesses that manufactures its products without even the most basic elements of a quality program is a letter. Is this really all an agency with the power to enjoin offending companies, institute seizure actions against volatile goods, and refer matters to the United States Attorney for strict criminal liability prosecutions can muster?

FDA is Broken

Companies introduce ingredients into the market without a thought of complying with the NDI Notification process and with no knowledge of whether their ingredient is really safe for human consumption. Unapproved new drugs masquerading as dietary supplements claim to treat cancer and are produced in facilities without even the most minimal quality programs in place. FDA’s refusal to exercise serious enforcement authority over these rogue products masquerading as dietary supplements has created an atmosphere where scofflaws feel free to operate. These companies know the worst thing that could most likely happen to them is FDA will send them a letter. Even then, after they receive a letter from the agency, many of these companies feel free to continue their outlaw behavior because they know that the chances are that the next thing they get from FDA will be another letter—not an injunction, not a seizure and certainly not a prosecution.

Whether it is because FDA is still having an institutional temper tantrum 20 years after the passage DSHEA and simply refuses to do anything to make the law really work, or if it is for some other unknown reason, FDA is broken. In these cases and many others, it has and continues to fail in its self-proclaimed mission of “protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.”

Printed with permission from Natural Products Insider.  All rights reserved.

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