by Marion Nestle

Currently browsing posts about: FDA

May 29 2012

The latest battle in the supplement wars: FDA v. DMAA

Welcome to the largely unregulated universe of dietary supplement marketing, in this case of DMAA, a.k.a. 1,3-dimethylamylamine, methylhexanamine, or geranium extract (from which it is supposedly isolated).
DMAA is supposed to stimulate athletic performance.
In April, the FDA sent letters warning ten DMAA distributors that it considered their products adulterated because:
  • DMAA does not naturally come from a food.
  • Most of it is produced synthetically
  • It might not be safe.
The FDA received 42 complaints of adverse events associated with taking DMAA supplements.  Although the reports do not prove that DMAA caused the problems, these are serious: cardiac disorders, nervous system disorders, psychiatric disorders, and death.The FDA says:

dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack).

One FDA warning letter went to a company called Muscle Warfare for its DMAA supplement “Napalm” which “produces intense sensations of power, drive, energy, focus, motivation, and awareness.  Enormous strength, speed and endurance increases may result.”

Here’s how the company says Napalm works:

Upon ingestion, energy is almost instantly kicked in with Air Strike while core body heat is dramatically supported. This extra body heat may then dramatically support the release of heat shock proteins, during your workout by way of our patent pending Thermobraic Heat Shock Protein Deployment System via Myobolic-SERMS/1&2….Muscle Pumps are fueled via a remarkable creatine free, Plasma Scorch Muscle Engorgement Agent….

Just pure power and dry hard size. Anabolism is kicked in by your ultra-intense workout coupled with our powerful mTOR pathways inducing Vaso-Anabolic Branched Chain Amino Acid Blend. Further hormonal anabolic support is induced by our patent pending NMDA™ hormonal support agent. NMDA™ specifically targets growth hormone, testosterone, IGF-1 and IGF-2 release and has been scientifically shown to provide dramatic support!

As I keep saying, you can’t make this stuff up.

The supplement industry, ever eager to find an athletic supplement that everyone will want to take has reacted with outrage to the FDA’s warning letters (see NutraIntredients-USA.com for a series of articles on DMAA).

Since Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, the supplement industry has gotten a virtually free pass on regulation and its less scrupulous members push the limits of marketing to the point where the FDA has no choice but to act.

DMAA supplement marketers now argue that if DMAA comes from geraniums, synthetic DMAA should be legal. 

I had no idea people were eating geraniums, but never mind.  The flowers may not contain DMAA anyway.

According to NutraIngredients, most DMAA is synthetic (hence: not natural):

There is only one study repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85) – which analytical testing experts contacted by NutraIngredients-USA say is “not scientifically defensible“.

The supplement industry views the warning letters as signs that the FDA is going to start giving its products greater scrutiny.

That would be a step in the right direction, but maybe the FDA won’t have to.  The warning letters elicited a flood of  class action lawsuits against DMAA.

If the FDA won’t or can’t act, lawyers will take up the burden of regulating potentially unsafe and misleadingly marketed supplements.

Update, June 29:  Oops.  Investigators fail to find DMAA in geranium extracts or oils. 

May 16 2012

Follow-up on sushi tuna scrape: it’s supposed to be cooked!

In response to my post on tuna scrape, Professor Alan Reilly, Chief Executive, Food Safety Authority of Ireland (the equivalent of our FDA) sent this photograph of an actual tuna scrape label.

 

After I forwarded it to Bill Marler, he noticed that it is one of several photographs posted on the FDA’s tuna scrape recall web page).

The type is too small to read so I’ve done some cropping:

Professor Reilly asks:

What is puzzling me is why this product “minced tuna” was used in sushi products. The label (copy attached) clearly states that the product must be cooked before consumption and it is for industrial uses only (labelled not for retail).

Those are good questions, but here’s another, equally alarming.  What’s that strangely formatted Nutrition Facts label? It does not precisely follow FDA design or content requirements.

This is a red flag.  If the company is not following labeling rules, it might not be  following other rules either—safety, for example.

Safety?  Uh oh.

Bill Marler reports that the FDA “483 Inspection Report” on the Indian tuna processing facility is now available.  Read these quotes and shudder:

  • Tanks used for storage of process waters have apparent visible debris, filth and microbiological contamination.
  • There is no laboratory analysis for water used in ice manufacturing at the [redacted] facility to show the water used to make ice is potable.
  • Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment.
  • Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

I draw several lessons from this episode:

  • Food is safer when cooked.
  • Labels need to be read—and followed—carefully.
  • Raw sushi is a high risk product, especially if it doesn’t cost much.
  • The FDA needs to be doing a lot more inspecting of overseas facilities, and before they cause problems.

All of this means that we need a better food safety system, one that can address the enormous proportion of our food supply that comes to us from countries with weaker food safety standards.

Addition, May 17: Ben Embarek, a food safety scientist at the World Health Organization notes that the 483 report reveals that Moon’s HACCP plan did not list appropriate critical control points.  Anyone auditing the plan should have picked up the problems on paper, which is easier and less expensive to do than an on-site inspection.  But the FDA does not pre-audit international HACCP plans.  They are supposed to be cleared by exporting companies registered by FDA.  Comment: it’s hard to imagine that the current system can work, and it clearly does not.

May 11 2012

FDA panel recommends approval of another iffy weight-loss drug

I was riveted by an article in today’s New York Times about the latest decision of an FDA drug advisory panel.

The panel voted to approve a new weight-loss drug, lorcaserin.  The vote was mixed: 18 for approval, 4 against, and 1 abstention. The majority felt that the benefits outweighed the risks and that even if there were risks, “new tools are needed to treat a major health problem.”

The benefits are worth a look.

  • People taking the drug lost an average of  5.8% of their body weight in a year, compared to 2.5% for people taking a placebo.  This difference is below the FDA’s standard for approval which requires a 5% difference.
  • Among those taking the drug, 47% lost at least 5 percent of their weight after a year, whereas only 23% of those taking the placebo did so.  This meets a second FDA standard for approval.

What about the risks?  The drug:

  • Causes tumors in rats (although perhaps at higher doses than might be taken by people).
  • Damages heart valves (in the same way the withdrawn drug, Fen-Phen, did).

Also in the Times is a piece by Dr. Danielle Ofri on her experience with patients who want weight-loss drugs.

She quotes from an essay called “Lemons for Obesity” by Dr. Michael S. Lauer, who was a minority voter on the FDA panel that approved the weight-loss drug Qnexa earlier this year.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Shares of the maker of the drug nearly doubled after the decision.  The Times reported that “Arguments by investors have been passionate.”

People who cannot easily lose weight are desperate for help.

But is it ethical to put them at this kind of risk?

May 10 2012

GAO says U.S. food safety system needs work, resources

The Government Accountability Office is complaining again about the inadequacies of the American food safety system, and with good reason.

Its 2012 Annual Report, Opportunities to Reduce Duplication, Overlap and Fragmentation, Achieve Savings, and Enhance Revenue, says that the food safety system is:

fragmented and results in inconsistent oversight, ineffective coordination, and inefficient use of resources.

In 2007, GAO added food safety to its list of high-risk areas that warrant attention by Congress and the executive branch.

More recently GAO found that this fragmentation extends to the responsibilities across multiple agencies to defend food and agricultural systems against terrorist attacks and natural disasters…Many of these activities are everyday functions or part of the broader food and agriculture defense initiative and would be difficult for the agencies to separately quantify.

This report repeats what the GAO has been saying since the early 1990s:

there is no centralized coordination to oversee the federal government’s overall progress in implementing the nation’s food and agriculture defense policy.

Because the responsibilities outlined in this policy (HSPD-9) are fragmented and cut across at least nine different agencies, centralized oversight is important to ensure that efforts are coordinated to overcome this fragmentation, efficiently use scarce funds, and promote the overall effectiveness of the federal government.

Reminder: the present food safety system is mainly divided between two agencies: USDA (meat and poultry) and FDA (everything else).

Centralized oversight of food safety?  What a concept.

May 9 2012

FDA’s Global Engagement

The FDA has just released a classy new report on Global Engagement, summarizing its efforts to deal with issues raised by the globalization of drugs, medical devices, and foods.

This is a big deal.  In 2009, 300,000 foreign facilities in more than 150 countries exported $2 trillion worth of FDA-regulated products to the United States.

Given these numbers alone, the FDA has some challenges.

In 2011, one out of every six FDA-regulated food products in the U.S. came from abroad.  Imports of fresh fruits, vegeta­bles, coffee, tea, and cocoa have more than doubled since 2000.

We import:

  • 80 percent of seafood
  • ~50 percent of fresh fruit
  • ~20 percent of fresh vegetables

As the report explains,

  • Many products entering the United States are made or grown in countries that lack the necessary regulatory over­sight to ensure their quality and safety.
  • Greater numbers of suppliers, more complex products, and intricate multinational supply chains introduce risks to product safety and quality, including more oppor­tunities for economic adulteration and the spread of contaminated products.
  • FDA can only realistically inspect a small percent­age (less than 3 percent) of the enormous volume of food products arriving at U.S. ports of entry, making it crucial that the Agency focus on ensuring that food products meet U.S. standards before they reach the United States.

To deal with this problem, the FDA has opened offices in:

  • China: Beijing, Shanghai, and Guangzhou
  • India: New Delhi and Mumbai
  • Latin America: San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico
  • Europe: Brussels, Belgium; London, United Kingdom; and Parma, Italy
  • Asia-Pacific: FDA headquarters
  • Sub-Saharan Africa: Pretoria, South Africa
  • Middle East and North Africa: Amman, Jordan

The FDA seems seriously concerned about its global initiatives and the safety problems posed by our globalized food supply.

The volume seems impossible to manage.  Let’s hope the FDA’s efforts do some good.

May 8 2012

The latest pet food Salmonella recall

A reader writes:

Here’s what I don’t understand.

Everyone who is scared of raw says they want their dog’s food to be cooked, to kill salmonella.

But here is kibble, which by definition is cooked to the point of losing most of its original nutrients, but STILL has salmonella.

I don’t see how this is possible.  If it’s cooked enough to be “kibbled,” how can it possibly still have salmonella? It just seems like the worst of all possible worlds.

This question refers to the recent recall of dry dog food manufactured by Diamond Pet Foods.

As the CDC explains, Michigan public health officials found Salmonella in an unopened bag of a Diamond kibble product during routine testing.  This particular Salmonella strain had been found to infect at least 14 people.

CDC investigators connected the dots between the illnesses and dog food through interviews:

Seven of 10 (70%) ill persons interviewed reported contact with a dog in the week before becoming ill.

Of 5 ill persons who could recall the type of dog food with which they had contact, 4 (80%) identified dry dog food produced by Diamond Pet Foods that may have been produced at a single facility in South Carolina.

In my book, Pet Food Politics: The Chihuahua in the Coal Mine, I tell the story of the massive pet food recalls of 2007 due to contamination with the industrial chemical, melamine.  And in Feed Your Pet Right, my co-authored book about the pet food industry, I explain how pet foods are manufactured and why they are so subject to contamination and recall.

Canned pet foods are sterile.  Dry kibble is not.  It may be sterile at the point of extrusion, but it is a perfect growth medium for bacteria.  It is nutritionally complete.  Although some nutrients are lost during processing, the product formulas compensate for such losses.  That is why dogs can survive on “complete and balanced” dry foods.

If the factory is contaminated with Salmonella, the bacteria can fall into the production lines and get packaged into the kibble bags.

Dogs are relatively resistant to Salmonella and usually do not show signs of illness from eating contaminated kibble.

But humans who handle the food or the dog can acquire the bacteria and get sick.

This makes dry dog food a potentially hazardous product, one best kept away from people with weak immune systems such as young children and the elderly.

People like feeding dry food to pets because it is convenient and cheap.

My point in Pet Food Politics was that pet food is an indicator of problems in food safety regulation.  If pet foods are not forced to be produced under strict food safety measures, humans and the human food supply are also at risk.

Resources

May 2 2012

FDA releases strategic plan for 2012-2016

Ordinarily I find government plans of this type to be soporific but this one is especially well written and well thought out (with some caveats).

The report is a statement of FDA commitment to what it is going to do in the next four years in food areas that affect people and animals.  It includes many promises, among them this one of particular interest: 

Program Goal 4: Provide accurate and useful information so consumers can choose a healthier diet and reduce the risk of chronic disease and obesity

Objective 1. Update the Nutrition Facts label.

  • Publish proposed rules updating the nutrition facts label and serving sizes [OK, but by when?].
  • Publish final rules updating the nutrition facts label and serving sizes [Ditto].

Objective 2.  Implement menu and vending machine labeling regulations.

  • Publish final menu and vending machine labeling regulations [OK, but by when?].
  • Collaborate with states, localities and other partners to ensure high rates of compliance.

Objective 3.  Improve consumer access to and use of nutrition information.

  • Explore front‐of‐pack nutrition labeling opportunities [Explore?  See comment below].
  • Collaborate with public/private sector parties on nutrition education [Collaborate?  See comment below].
  • Implement updated standards for the labeling of pet food including nutrition and ingredient information [How about a Pet Facts label for pet foods that someone might actually be able to understand?].
  • Implement standards for animal feed ingredients.
  • Publish final rule defining and permitting use of the term “gluten free” in the labeling of foods.

Goal-setting processes usually include dates by which the objectives are to be completed.  These do not, which suggests that the FDA can continue to delay action until 2016. 

I also do not understand what is meant by “Explore front‐of‐pack nutrition labeling opportunities.”  Explore?  The FDA has already sponsored two Institute of Medicine reports on front-of-pack labeling.  Does this mean the agency is ignoring them and intends further research?

And “Collaborate with public/private sector parties on nutrition education?”  What does the FDA have in mind for the content of such education?  You can bet that no collaborative campaign can focus on “don’t drink your calories.” 

FDA needs to deliver on these items, and sooner rather than later.  This year?  I’m not counting on it.

 

Apr 12 2012

The FDA takes action on animal antibiotics, at long last

Yesterday, the FDA proposed long-awaited action against use of antibiotics for non-therapeutic purposes in animal agriculture.

From the outside, this might look more like inaction.  The agency is asking drug companies to voluntarily cut back on producing antibiotics for non-therapeutic purposes and to require veterinary oversight of use of these drugs.

The announcement comes in the form of three documents in the Federal Register.

  • Final Guidance for Industry: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.
  • Draft Guidance for Industry aimed at assisting drug companies in voluntarily removing from FDA-approved product labels uses of antibiotics for production rather than therapy, and voluntarily changing the marketing status to include veterinary oversight.  This is open for public comment.
  • A draft of a proposed Veterinary Feed Directive regulation,  also open for public comment, outlining how veterinarians can authorize the use of antibiotics in animal feed.

In an FAQ on the announcement, the FDA answers some obvious questions:

4. What is “judicious use” and what are FDA’s recommendations?

“Judicious use” is using an antimicrobial drug appropriately and only when necessary;

Based on a thorough review of the available scientific information, FDA recommends that use of medically important antimicrobial drugs in food-producing animals be limited to situations where the use of these drugs is necessary for ensuring animal health, and their use includes veterinary oversight or consultation.

FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use (my emphasis).

5. Why did FDA decide to do this now?

FDA has worked with many stakeholder groups and the U.S. Department of Agriculture (USDA) to develop a strategy that will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agricultural industry.

In June 2010, FDA released a draft guidance document explaining its recommendations for change and in the interim period sought and received input from various stakeholders, including the animal pharmaceutical industry, animal feed industry, veterinary and animal producer communities, consumer advocacy groups and USDA.

Translation: this has been in the works for a long time and is the result of extensive discussions with the relevant industries.

As Food Safety News explains, the reaction of just about everyone to this announcement has been tepid.

  • Food safety advocates object to voluntary, because it never works.
  •  The meat industry insists that non-therapeutic antibiotics are essential for producing cheap meat under crowded conditions.

For example, the National Pork Producers make the usual industry arguments:

Harm to small farmers: The guidance could eliminate antibiotics uses that are extremely important to the health of animals…And the requirement for VFDs [veterinary oversight] could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.

Voluntary equals regulation: The guidance, which does not have the force of law but may be treated as such by FDA, is a move to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on the use of antibiotics in livestock and poultry production.

The science is “junk”: But numerous peer-reviewed risk assessments, including at least one by FDA, show a “negligible” risk to human health of antibiotics use in food-animal production.

My interpretation:

The FDA’s position on non-therapeutic use of antibiotics in animal agriculture is quite clear.  The agency recognizes that based on the science, the use of antibiotics as growth promoters in animals poses a serious risk to human health.

I’m guessing this is the best the FDA can do in an election year.

This move looks to me like a direct challenge to drug companies and meat producers to clean up their acts and take some responsibility for the effects of their misuse of animal antibiotics on public health.

It’s also a challenge to food safety advocates to make sure that the FDA monitors the effects of its voluntary guidance and, if the industries don’t cooperate, that the FDA gets busy on real regulations.

Addition: The account in today’s New York Times explains why the FDA is starting with voluntary efforts:

The reason for the reliance on voluntary efforts is that the F.D.A.’s process for revoking approved drug uses is lengthy and cumbersome, officials said. The last time the F.D.A. banned an agricultural use of a medically important antibiotic against the wishes of its maker, legal appeals took five years. In this case, hundreds of drugs are involved, each with myriad approved uses in various animals.

“You and I and our children would be long dead before F.D.A. could restrict all of these uses on its own,” Ms. Rogers [of the Pew Foundation]said.

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