Regulation

Observers disagree about whether report of tainted thyroid supplements points to wider problems in market

24-Jan-2014 - By Hank Schultz
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A recent blog in The New York Times raised questions about some thyroid supplements, but passed over the legitimate role dietary supplements scan have in the support of health thyroid function, observers say.

In the blog, author Roni Caryn Rabin cited a scientific paper published in the November issue of the scientific journal Thyroid.  The paper’s authors tested 10 commercially available supplements marketed for ‘thyroid support.’ They found that all of the products had detectable levels of the hormones thyroxine (T4) and triiodothyronine (T3). Nine out of 10 supplements revealed a detectable amount of T3 (1.3–25.4 μg/tablet) and 5 of 10 contained T4 (5.77–22.9 μg/tablet). Taken at the recommended dose, five supplements delivered T3 quantities of greater than 10 μg/day, and 4 delivered T4 quantities ranging from 8.57 to 91.6 μg/day, the authors found.  Some of the supplements with higher dosage levels delivered more of the hormones than typical prescription drugs do, the authors concluded.

“The authors of the scientific article did say they thought some products had added T3 or T4,” said Duffy MacKay, ND, vice president of scientific and regulatory affairs  told NutraIngredients-USA. “That is unacceptable and something that CRN is against.  Nobody should be adding synthetic ingredients to supplements to achieve an effect.  That’s dangerous and wrong.”

“Once a product is adulterated with a prescription drug, it is no longer considered a dietary supplement, it is considered an illegal drug, and it needs to be handled as so. This is a serious concern for the entire dietary supplement industry, and NPA fully supports FDA’s efforts in removing products such as these from the market. It’s important that products are what they say are for consumer safety,” said John Shaw, CEO of the Natural Products Association.

But MacKay said part of the issue revolves around the peculiar way in which glandular ingredients are regulated. Ingredients made form desiccated glands of animals were on the market in 1994, and so are legal dietary ingredients grandfathered in under DSHEA.  But to be legal they must have the hormones removed.  Drugs providing T3 and T4 thyroid hormones are made form animal glands, too.  So MacKay said it’s possible some of the supplements tested may have been manufactured by companies not fully up to speed on all of the somewhat arcane aspects of the regulations regarding glandulars, and put out products with trace amounts of hormones as opposed to intentionally spiking them with added hormones.  Even if that might be true it’s not something he condones, MacKay hastened to add.

Supplements can help

So that’s the bad news.  The good news is that Rubin correctly characterized how dietary supplements are regulated and avoided the ‘unregulated’ charge that is so often trotted out in mainstream media reporting on the sector.  Part of that may be attributed to the greater editorial rigor of that particular newspaper, MacKay said. But part of it may also be because the education efforts that the trade associations have made with national media organizations are starting to bear fruit.

But a big piece of potential good news that was missing from the Times piece is that supplements can help, MacKay said.

One thing that was missing from the New York Times article was a discussion of the role that dietary supplements can have in supporting health thyroid function,” he said.

“Some patients exhibit a condition called subclinical hypothyroidism.  They exhibit all the classic signs—low energy, dry skin, hair falling out—but their test values don’t give a frank diagnosis of hypothyroidism.  And without that a doctor won’t prescribe thyroid hormones.

“But its known that in cases where those patients are given a little bit of hormones the symptoms go away and they feel better.  Those are the kind of patients who, if they don’t want to use a drug, could consider using one of the gentler botanical alternatives, like adaptopgenic herbs that have been shown to be effective in supporting thyroid function such as ashwagandha or bladder wrack,” MacKay said.

Questions of quality and safety

Jason Sapsin, a Denver-based attorney with Fox Rothschild who representers many dietary supplement companies, has a somewhat different take.  Sapsin has a unique view in that he spent time at both FDA and at Johns Hopkins University, where he completed an advanced degree in public health.  In his view, the problems detailed in the Times piece are just a sample of ongoing, unsolved issues that plague the industry.

“I don’t know if (the findings of the scientific paper) come as a big surprise,” Sapsin said.

“This sort of thing continues to damage the dietary supplement market. It’s not jus about thyroid supplements, but any segment of the supplement market that is addressed to health conditions that are amenable to rapid results is susceptible,” he said.

Sapsin said an unspoken element that hovered over this story and others like it is whether supplements should have pre market safety approval.  The fact that a supplement can go on the market without a stamp of approval from FDA is greeted by disbelief and consternation among even more highly educated sectors of society, he said.

The question is who’s monitoring the process,” Sapsin said. Under DSHEA, the responsibility for making sure supplements are safe before they hit the shelves rests with the manufacturer.

“The manufacturer may be the biggest, most ethical company in the world. Or it could be somebody operating out of shed,” he said. This makes for a very tilted playing field in which some companies spend big bucks to be compliant while the shed dwellers skulk in with very little in the way of safety protocols.

“The typical response from an organization like CRN is that this is a few bad apples that spoil the bunch. The question is how many bad apples is too many? If you are a consumer who has been injured by a product, it doesn’t matter if there was one bad apple or 50. What is an acceptable level of risk?” Sapsin said.

Related topics: Regulation, Dosage forms & delivery formats, Weight management, Women's health, Healthy aging, Men's health