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Coordinated Fed Enforcement Has Supplement Industry Playing Defense

By Erik Goldman

A coordinated set of enforcement actions by the Food & Drug Administration, the Federal Trade Commission, the us dojDepartment of Justice, the Department of Defense, the postal service and several other federal agencies has the dietary supplement industry playing defense....and also applauding.

Earlier this month, the Department of Justice announced its pursuance of civil and criminal cases against more than 100 supplement makers, charging them with illegal spiking of supplements with pharmaceuticals, inclusion of ingredients that are inappropriate for use in supplements, or making false, unsubstantiated or misleading marketing claims.

The largest case with the highest profile was the set of criminal charges brought against a Texas company called USPlabs, maker of workout and weightloss thermogenic "supplements" that actually contain fluoxetine as well as synthetic stimulants. The company's most popular product called OxyElite Pro, has been the subject of multiple previous enforcement actions, including a 2013 order from the FDA to stop distribution of the product following multiple reports of liver failure in OxyElite users. 

In this month's action, USPlabs executives have been brought up on criminal charges.

The current federal sweep includes five civil court cases alleging fraud, misleading advertising, failure to comply with good manufacturing procedures, unlawful sale of illegal ingredients, and promotion of supplements as cures for diseases including cancer and arthritis. The FTC has also brought dozens of civil actions alleging false and misleading advertising. Regulators have been particularly focused on supplements marketed for muscle-building and athletic performance enhancement, sexual enhancement products, those containing poure powdered caffeine, those containing the substances BMPEA and DMBA which are considered illegal by federal agencies.

(For links to further info on various indictments, see list below).

Loren Israelsen, executive director of the United Natural Products Association (UNPA) says that his organization applauds the coordinated effort to eliminate bad players from the rapidly growing industry.

Loren Pic bio"We were gratified to see the breadth of agencies represented. UNPA and responsible industry have long urged regulators to take decisive action against noncompliant products," said Israelsen in a statement issued by UNPA.

"We encourage regulators to continue to assure consumers of wide access to safe, beneficial and well-researched dietary supplements. For our part, we will continue to work closely with all regulators on the types of cases they described today to support and encourage a supplement industry that operates within the law and continues to be deserving of widespread consumer trust."

Israelsen and other supplement industry leaders say this month's regulatory assault goes a long way to counter the oft-heard canard that the supplement industry is unregulated. “The clear message for industry, Congress, the media and consumers is that there is broad authority held by various agencies to regulate dietary supplements.

The federal actions follow a year of state-level clampdowns heralded by the New York Attorney General's attempt to take down major supplement retailers like GNC and Vitamin Shoppe on allegations they were selling fraudulent herbal products. Though AG Schniederman's efforts were largely rebuffed, they did set precedent for a number of AG actions in other states, as well as a tide of class-action lawsuits.

While he says he welcomes stronger enforcement efforts aimed at eliminating truly fraudulent and dangerous products, Israelsen said he is also concerned that some regulators may be less concerned with public protection and more concerned with election year politics.

There is a fine line between policy that protects the public and encourages the highest standards in product manufacture, and one that's designed to thwart what is currently a thriving industry. Israelsen sees rough seas ahead for supplement companies, particularly those playing in the big box retail or online sectors.

For the most part, regulators are not targeting healthcare professionals who dispense supplements. Compared with major retailers, dispensing clinicians are very low profile, and they tend to be dispensing practitioner-grade products that are typically made to pharma standards and are much less likely to contain undeclared, ilicit or dangerous ingredients.

Further, Israelsen surmises that neither the Attorneys General nor the federal regulators want to get tangled up in matters of clinical judgment or physician-patient relationship issues.

For more information on recent regulatory actions:

Download Bethel Nutritional complaint (1.9 MB)

Download optimum complaint - filed (552.09 KB)

Download vibrant life complaint - filed (79.41 KB)

Download Viruxo filed complaint (676.94 KB)

Download Vivaceuticals Inc Complaint (112.27 KB)

Download Supplement Sweep Chart to release_2015-11-12_updated (29.19 KB)

Download USP Labs indictment_with redactions final (2.74 MB)

When White is Alright

By Erik Goldman

CauliflowerWhite-colored foods have a generally bad reputation among health conscious people, and for very good reason: many of the most toxic and nutritionally vapid foods have had all the color beaten out of them. Bleached flour, sugar, white bread, vegetable shortening are just a few that quickly come to mind.

But not all white foods are bad, stresses nutritionist Deanna Minich, PhD. Some of them are downright healthful, especially for people on detoxification diets.

Here are a five of Dr. Minich's favorite pale but powerful vegetables that shouldn't be overlooked when "eating the rainbow."

Cauliflower: One of the many cruciferous vegetables that can assist in healthy detoxification processes in the liver, cauliflower is more than half as potent as the “detox superstars,” broccoli and kale; Eating some occasional cauliflower is a good way to add some variety to your cruciferous vegetable intake. A study in 2007 (Kirsh et al.) found that “High intake of cruciferous vegetables, including broccoli and cauliflower, may be associated with reduced risk of aggressive prostate cancer, particularly extraprostatic disease.” Cauliflower has a low glycemic index of 15-30. "One of my favorite ways to prepare it is to briefly sauté the florets in extra-virgin olive oil and spices and serve warm," she says.

Onions: These gorgeous white orbs are healing and helpful for blood sugar, heart health, and, most definitely, detox; They contain at least 25 different plant compounds called flavonoids, with one of the most popular ones known as quercetin, a potent antioxidant. Red onions tend to contain just a bit more of the flavonol phytonutrients than the yellow onions, although there is some variability, based on where the onion was grown. Most of those phytonutrients are right below the skin, so do not overpeel your onions! Onions have a very low glycemic index of 10-15.

Garlic: Garlic is a detox heavy-hitter, garlic is much like the other white foods listed here. It has so many medicinal uses, from lowering cholesterol to balancing blood sugar to helping with heart health and blood pressure. When it comes to detox, its sulfur and selenium content come in handy. Let raw garlic sit after cutting it to maximize the production of protective antioxidants.

Coconut Milk: Dr. Minichs's Whole Detox recipes emphasize coconut oil and coconut milk, primarily because of the content of short- andmedium-chain fats which are helpful for the healing of the gut, and also because they are quickly burned as fuel by the liver. Coconut products have a reputation for their anti-microbial and anti-viral effects. One recent study surprisingly showed that an extra-virgin coconut-containing diet decreased waist size and increased good cholesterol in people with coronary artery disease.

Turnips & Parsnips: Raw turnips have a low glycemic index, though that becomes pretty high when they are cooked. Parsnips have a medium to high glycemic index when cooked, but both provide great opportunities to increase fiber intake, along with a complex array of different plant nutrients that protect the body from oxidative stress damage. Often used in stews and soup, they add a lot of flavor. It is important not to overcook them because they will become mushy and higher in glycemic impact. Both turnips and parsnips can be shredded into salads as a tasty touch!


AMA Calls for Ban on Consumer Drug Ads

By Erik Goldman

The American Medical Association's leadership has called for a complete ban on direct-to-consumer advertising for prescription medications and medical devices.

The organization announced the move, which it says it will back with a strong lobbying campaign, at its annual policy-making Patrice Harris.Fullmeeting in Atlanta earlier this month.

Drug company spending topped $4.5 billion this year, according to the AMA, and reflets a 30% increase in the last 2 years alone. AMA leadership contends that the bloated marketing budgets driving that expenditure are a major factor in soaring drug costs. Further, the physicians' group says the drug ads stoke patient demand for treatments that are often not necessary,  and put pressure on physicians to prescribe when it is not appropriate. 

The vote, "reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said AMA Board Chair-elect Patrice A. Harris, M.D., M.A. “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

Not surprisingly, the pharmaceutical industry disagrees. Tina Stow, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, contends that DTC ads transmit "scientifically accurate information to patients so that they are better informed about their health care and treatment options."


Given all the handwringing about healthcare costs, on top of all the election year politics, this showdown could be more exciting than the Superbowl.



Hey Big Spendah! AMA, Pharma Among Top Influence Purchasers

By Erik Goldman

The old expression “Money’s the answer. What’s the question?” comes quickly to mind in light of a recent analysis of political lobbying expenditures.

Hospitals No Longer Safe Havens in War Zones

By Erik Goldman

The targeting of medical facilities, evidenced by the Oct. 3 bombing of a Doctors Without Borders hospital in Kunduz, Afghanistan is a disturbing trend, one that runs counter to long-established humanitarian principles.

What's the New ICD-10 Code for "Financial Toxicity"?

By Erik Goldman, Editor in Chief

There’s a devastating but largely overlooked side-effect that threatens the efficacy of many promising cancer therapies: it is called "financial toxicity." That’s the official new term devised by cancer researchers to describe the cost burden of medical care. There's even a clinical tool to measure it.



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