Fed Budget Bill: Two Wins, One Loss for Food Labeling

By Erik Goldman

The $1.1 trillion Federal spending bill passed by Congress this week includes a two minor wins for advocates of GMO labeling, but a significant loss for anyone concerned about food safety standards and the environmental costs of food transport.

First, the good news: Congress jettisoned a provision that would have prohibited state legislatures from passing or implementing their own GMO labeling laws, in favor of creating a single national review board to assess the safety of genetically-modified ingredients. The bill was officially called the "Safe and Accurate Food Labeling Act," but GMO critics refer to it as the Deny Americans the Right to Know (DARK) act.

The new budget bill also mandates that the Food and Drug Administration issue final guidelines for the labeling of the genetically-modified salmon species that the agency approved for market in November. The bill allocates a whopping $150,000 to fund the labeling guideline project and to implement a consumer disclosure program. (UpShots sincerely trusts that the commissioners will use discretion and not blow that $150K on wild Alaskan salmon caviar at their planning luncheons).

Big Food manufacturers and retailers have voiced disappointment over the non-passage of the "Safe" act. By leaving the field open to individual state initiatives, Congress is fostering "a patchwork of costly and misleading state labeling mandates," says Pamela Bailey, president of the Grocery Manufacturers Association, a massive food industry lobbying group that has been strongly opposed to GMO labeling.

On the near horizon is the implementation in January of the State of Vermont's GMO labeling mandate, which was approved by the Green Mountain state's legislature in 2014. Bailey has indicated that her constituents are less-than-happy about having to comply.

But they can console themselves by knowing that the budget bill nixed a requirement that all imported meat products be labeled with country-of-origin information. That's a big loss on the transparency front, because it means that companies and retailers will not be required to disclose where the meat was grown, harvested or processed. Lawmakers say they took that decision in order to avoid punitive tarriffs from other countries (ie China) that opposed country-of-origin labeling.

It's a pretty safe bet that the omnibus budget bill is packed with pork. But, alas, we will not be able to know where it came from.



Vaccine Critics Get Shot in the Arm from NYC Court

By Erik Goldman, Editor in Chief

A Manhattan Supreme Court judge has ruled that New York City's health department does not have the legal authority to add flu vaccines to the list of mandatory shots required for young children to enter city-licensed preschools and day care centers.

According to Justice Manuel Mendez, any changes to the roster of the city's required shots--which currently includes polio, mumps, measles, rubella, varicella, Haemophilus influenza B, pertussis, tetanus, pneumococcal diseases, meningitis, and hepatitis B--must be mandated by the New York State legislature, not the city's board of health.

The flu vaccine mandate was a parting shot from the administration of former Mayor Mike Bloomberg, and was set to take effect on January 1, 2016. But the legality of the requirement was challenged by a lawsuit filed by parents concerned about the potential risks. Also at issue in the case is the fact that the city's health board is appointed, not elected, and therefore may not represent the views of the city's citizens. 

In his ruling, Judge Mendez stuck closely to the matter of the Board of Health's legal authority to change vaccine policy; he assiduously avoided issues related to the merits or risks of the flu vaccine, the legality of vaccine mandates in general, or any of the other contentious issues about vaccines.

Essentially, Mendez' decision merely bounces the matter upstairs to the state legislature in Albany.

Still, vaccine opponents are hailing it as a significant victory for parental freedom of choice. City health commissioner, Dr. Mary Bassett, is disappointed. She holds that the mandate could have prevented many cases of childhood as well as adult flu, and potentially saved lives.




Rademenes: A Cat Healer Finds His Calling

By Erik Goldman

Rademenes barely made it past his second month of life.

The small black kitten was on the verge of death in the street in the small town of Bydgoszcz, Poland,  when a kind stranger found him and took him to an animal shelter. The vets there were considering euthanasia, but something stayed their hands.

CatCompassionThe kitten recovered, and soon became something of a clinician himself. He has taken to nursing other sick animals at the clinic by cleaning them, cuddling them, and keeping them company as they come out of surgical procedures. Lucyna Kuziel, a veterinarian at the clinic where Rademenes is now a permanent "attending" says the cat pays particularly close attention to other animals who are very sick or who are going through surgery.

"It's as if having been so close to death's door himself, he now wants to help others get better."

Rademenes is both fearless and species-agnostic, showing no hesitation about comforting big dogs with the same tenderness he gives to his own feline kind.

The healer cat is named for the sage-like feline protagonist from a popular 1980s Polish children's TV series called Siedem Zyzcen ("Seven Wishes").

Like his namesake, the real-life Rademenes is himself becoming a rising star in the online cat video universe. 

Many people hold a view that cats are not social creatures. Rademenes is clear evidence to the contrary. He's an exemplar of compassion, and one from whom we all could learn.





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 bioLoren Israelsen, Executive Director, United Natural Products Alliance"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.FullPatrice Harris, MD, AMA Board Chair - electmeeting 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.