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The Evolution of Dietary Supplement Marketing

In 1994 Congress (pushed by Senators Harkin and Hatch) passed DSHEA (the Dietary Supplement Health and Education Act). As regular readers of SBM know, we are not generally happy about this law, which essentially deregulated the supplement industry. Under DSHEA supplements, a category which specifically was defined to include herbals, are regulated more like food than like medicinals.

Since then the flood-gates opened, and there has been open competition in the marketplace for supplement products. This has not resulted, I would argue, in better products – only in slicker and more deceptive claims. What research we have into popular herbals and supplements shows that they are generally worthless (except for targeted vitamin supplementation, which was already part of science-based medicine, and remains so).

A company can essentially put a random combination of plants and vitamins into a pill or liquid and then make whatever health claims they wish for their product, as long as they stay within the “structure-function” guidelines. This means they Read more »

*This blog post was originally published at Science-Based Medicine*

New Regulations To Be Placed On The Dietary Supplement Industry

A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.

The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.

Stepping back, the goal of the FSMA makes perfect sense: Read more »

*This blog post was originally published at Science-Based Medicine*

When Dietary Supplements Are Used As Medicines

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly.Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again — and maybe by writing this post I can make it easier for new readers to find the information.

Food, Medicine, or Something In Between?

The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.

Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).

So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1,000 times the intended amount.

The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality. Read more »

*This blog post was originally published at Science-Based Medicine*

New Recommendations For Vitamin D

Vitamin D has been talked about as the vitamin — the one that might help fend off everything from cancer to heart disease to autoimmune disorders, if only we were to get enough of it.

“Whoa!” is the message from a committee of experts assembled by the Institute of Medicine (IOM) to update recommendations for vitamin D (and for calcium).

The IOM committee’s report, released this morning, says evidence for many of  the health claims for vitamin D is “inconsistent and/or conflicting or did not demonstrate causality.” The exception is the vitamin’s well-documented (and noncontroversial) benefits on bone growth and maintenance.

The IOM panel’s report also says most North Americans (Canadians as well as Americans) have more than enough vitamin D in their blood to achieve the desired effect on bone. The committee said a blood level of 20 nanograms per milliliter (ng/mL) is sufficient for most people.

The panel set 600 International Units (IU) as the recommended daily intake for children and for adults ages 19 to 70. People ages 71 and older are supposed to get an additional 200 IU, or 800 IU a day.

That’s a fairly sizable increase over the previous recommendations of 200 IU per day through age 50, 400 IU for people ages 51 to 70, and 600 IU for people ages 71 and older. Read more »

*This blog post was originally published at Harvard Health Blog*

High Cholesterol And Red Yeast Rice Supplements

People are always on the search for “natural” ways to stay healthy and reduce cholesterol. Chinese red yeast rice supplements have been touted as a natural, safer way to lower cholesterol compared to statin medications. The yeast that grows on a particular type of rice contains a family of substances called monocolins, which lower cholesterol by inhibiting cholesterol production in the liver in the same manner as prescription statin drugs. Some studies have shown as much as a 15 percent drop in cholesterol.

All of this sounds good until you dig a little deeper. Supplements are not regulated by the Food and Drug Administration (FDA), and a new study in the Archives of Internal Medicine showed that different brands of red yeast rice supplements have dramatic variation in levels of active ingredients. Furthermore, some contained toxic manufacturing by-products. Read more »

*This blog post was originally published at EverythingHealth*

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When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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