Search results: Complaint

Food Chemical News has discovered a stunning set of documents, made available by the Department of Health and Human Services as part of a transparency initiative, that prove FDA was forced by the White House Office of Management and Budget to remove certain elements from the draft of its FDA Food Safety Modernization Act preventive controls proposal. It had long been speculated among FDA watchers that the agency intended to include requirements for product testing, maintaining supplier verification programs and tracking consumer complaints in its FSMA proposal, published in the Federal Register Jan. 16, but the eight documents we found this week, while searching for other information, confirm it.

Food Chemical News is reporting that documents released on regulations.gov on Feb. 28 reveal cuts made by the White House Office of Management and Budget (OMB) to the implementing regulatory package for the Food Safety Modernization Act (FSMA).Those apparent cuts include striking out requirements for food companies to test for microbial contamination of environments and finished food products, as well as rules for companies to maintain supplier verification programs and track consumer complaints.

We encourage readers to review the documents here and comment on anything of interest in our comment section.

The bad news about dietary supplements pours in.  Most of them are harmless, but this industry is largely unregulated and the lack of oversight shows.

Here’s a brief summary of recent reports and an old one I’ve been saving for an occasion like this:

Some supplements do more harm than good

     A lengthy investigative report in the New York Times describes the death of a 22-year-old Army private attributed to taking a recommended dose of a workout supplement, Jack3d, bought at a GNC store on the base.

Jack3d contains a powerful stimulant called dimethylamylamine, or DMAA for short, which has similar effects as amphetamines, but claims to produce “ultra-intense muscle-gorging strength, energy, power and endurance.”

Some supplement companies don’t report problems to FDA

The Government Accountability Office (GAO), in Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products, reports a doubling of the number of adverse event complaints to the FDA since 2008.  It attributes the increase to FDA’s enforcement efforts and to lawsuits publicizing situations in which supplement firms are not reporting problems.

Some supplement companies can’t back up health claims

Last year, the Department of Health and Human Services’ Office of Inspector General (OIG) issued two reports examining health claims on immune support and weight loss supplements, both fast-growing segments of the industry.

In its first report, Structure/Function Claims Fail To Meet Federal Requirements, the OIG points to FDA’s limited enforcement authority over such claims.  As a result, supplement companies cut corners and ignore requirements for such claims.

Some supplement companies make it hard to complain

In its second report, Dietary Supplements: Companies May Be Difficult To Locate in an Emergency, OIG says that many supplements do not put information about where to file adverse event reports on their labels.   Many companies fail to register with the FDA.  And when companies do register, they neglect to provide required information.  About 20% of dietary supplement labels dd not provide telephone numbers or addresses where consumers can report adverse events.

The supplement industry brought this on itself

A year or so ago, the New York Times published a long article about the cozy relationship between Senator Orrin Hatch (Rep-Utah) and the supplement industry.

If you want to understand how the supplement industry gets away with ignoring regulations, read how “Senator Orrin G. Hatch has helped the nutritional supplement industry, and been rewarded with donations.”

He was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable.

When Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, it effectively deregulated the industry, allowing it to use a new category of vague health claims (“structure-function”), to use Supplement Facts labels, and to escape much in the way of oversight.

Even if we assume that most supplement manufacturers are honest about what’s in their products and what the products can and cannot do, some are not.  DSHEA gave the less honest manufacturers plenty of room to cause trouble, and so they do.

We will be seeing more such reports, no doubt.

When it comes to feeding kids, it is not possible to overestimate the self-interest of food producers—and their friends in Congress.

Forget about childhood obesity and other child health problems.  If you want to understand why school nutrition standards are so controversial, you must pay close attention to their effects on the financial health of the companies selling food to school meal programs.

Corporate health trumps kids’ health every time.

That is the lesson to be drawn from USDA’s December 7 announcement that it will allow schools some flexibility in implementing school nutrition standards for meat and grains.

As long as the schools meet minimum requirements for meat and grain servings, they no longer have to restrict the maximum size of servings.

This may be a trivial change; schools will still have to serve mostly whole grains and adhere to calorie standards.

But was this decision political?  Of course it was.

Despite two Institute of Medicine reports recommending improvements in the quality of school meals, Congress has chosen to micromanage USDA’s regulations.  Recall: tomato sauce on pizza now counts as a vegetable serving.

In October, three members of Congress asked the Government Accountability Office to investigate whether the new school nutrition standards resulted in higher costs and more food waste.  In November, Senator John Hoeven (Rep-ND) and 10 other senators, all from meat- and grain-producing states, that they were hearing complaints from constituents about kids going hungry in school.

In response, USDA Secretary Tom Vilsack reassured Senator Hoeven that USDA was listening to the complaints and was taking steps to address them: “you should be pleased to know that we have recently moved to allow for additional flexibility in meeting some of the new standards.”

On December 8, Senator Hoeven issued a news release:

The rule had appeared to pose problems…especially for students in low income families, students in athletics programs or students in school districts with limited operating budgets. Moreover…it may be difficult for all students to get adequate protein to feel full throughout the school day. Protein is an important nutrient for growing children.

“I’m grateful to Secretary Vilsack for recognizing that the rules need to allow for individual differences among children and the prerogatives of local school districts, and resources available to them,” Hoeven said. “While we welcome this news from USDA, we believe the new flexibility should be permanent, rather than for just the 2012-2013 school year, and we will continue to press that case.”

Protein?  Since when is protein an issue in American diets?  (Most Americans, even kids, get twice the protein required).

What’s at stake here are sales of meat and grains to school lunch programs.

What’s also at stake is what comes next.

USDA has yet to issue regulations for nutrition standards for vending machines and competitive snacks and sodas sold in schools outside the lunch programs.

You can bet that Congress—which seems to have nothing better to do—will be taking a close interest in those rules as well.

If what’s happening with school meals proves nothing else it is that Congress cares a lot more about the health of the industries that support election campaigns than it does about the health of children.

Sad.

Concerns that highly caffeinated Monster Energy drinks might be responsible for the recent deaths of at least five young adults are, as I see it, a direct result of deregulation of food oversight.

Here’s my version of the history leading up to the present situation:

• In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which in essence deregulated dietary supplements, permitted them to be labeled and regulated as supplements, not foods, and removed much of FDA’s authority over their contents and health claims.
• The dietary supplement industry, as I explain in Food Politics, wrote much of the key language of this law.
• When the FDA tried to enforce its food rules for supplements, the courts ruled in favor of manufacturers on First Amendment grounds.
• Because rules for supplements are less restrictive than those for foods, some manufacturers prefer labeling their products as supplements.
• Monster Energy drinks are labeled as supplements, removing them from much of FDA’s authority.

The results of DSHEA, in this case, are explained by the New York Times:

But while the F.D.A. regularly makes adverse event reports about drugs and medical devices publicly available, it does not do so for dietary supplements like energy drinks. Because of that policy, consumers had no way of knowing of the complaints about Monster Energy drinks before incident reports were released by the F.D.A. in response to a formal Freedom of Information Act request.

Also, while supplement makers have been required since late 2007 to alert the F.D.A. to possible product-related deaths and injuries, Monster Beverage submitted just one such report to the agency over the last four years, agency officials said.

Most likely because of their high caffeine content, sales of energy drinks are rising rapidly, as shown in this graphic from the Times:

Booming sales means booming profits, and the makers of energy drinks are under pressure to cash in.  That sometimes means cutting corners or not always matching contents to labels.

For example, a Consumer Reports investigation of the caffeine content of energy drinks identified some discrepancies.

Caffeine levels per serving ranged from about 6 milligrams to 242 milligrams per serving—and some containers have more than one serving. The highest level was in 5-hour Energy Extra Strength; the lowest in the seemingly oxymoronic 5-hour Energy Decaf…By comparison, an 8-ounce cup of coffee has about 100 milligrams; a 16-ounce Starbucks Grande, 330 milligrams.

Consumer Reports noted one other key point: the FDA considers caffeine as GRAS (Generally Recognized As Safe) and does not require amounts to be listed on labels.

A representative of the Monster Beverage Corporation explained that his company does not list caffeine levels “because there is no legal or commercial business requirement to do so, and also because our products are completely safe, and the actual numbers are not meaningful to most consumers.”

Consumer Reports points out that Monster drinks—like those of 16 other products—warn against use by children, pregnant or nursing women, and people sensitive to caffeine, and recommend a daily limit.

Whether the Monster Energy drinks are really responsible for the reported deaths will not be easy to establish.  One victim, age 14, is said to have consumed two 24-ounce Monster drinks containing 240 mg caffeine each within a day or two.

That energy drinks are labeled as supplements ties the FDA’s hands in dealing with such products.

Here are some suggestions to consider:

• Label energy drinks with standard Nutrition Facts panels.
• Require amounts of caffeine to be stated on the label.
• Limit the amount of caffeine that can be included in soft drinks.

Two Senators (Durban and Blumenthal)—not for the first time—are pushing the FDA to investigate.  Good idea.  I can only speculate about why the FDA isn’t responding, but I’m guessing that this issue, like so many others, is too controversial to take up during an election campaign.

Soon, please.

Mayor Bloomberg’s cap on soda sizes at 16 ounces has elicited a hard-hitting, Friday-afternoon (let’s hide it if we can), but otherwise well organized cease-and-desist lawsuit from the soft drink industry.

The suit, New York Statewide Coalition of Hispanic Chambers of Commerce et al. v. The New York City Department of Health and Mental Hygiene et al., is represented by Latham & Watkins, a law firm that often represents the American Beverage Association (ABA), the leading soft-drink trade group and one of the plaintiffs in this case.

Other plaintiffs are the Teamsters Local 812, the Korean-American Grocers Association of New York, the National Association of Theatre Owners of New York State, and—-no surprise—the National Restaurant Association.

These groups are all concerned that the soda cap might encourage people to reduce soda sales (its point, after all).  This would drive down profits for stores, concession stands in movie theaters, restaurants, and the people who distribute sugary beverages.

The basis of the suit includes these complaints [with my comments]:

• The Board of Health does not have the legal authority to cap soda sizes at 16 ounces (only the City Council does): “This case is not about obesity in New York City,” the plaintiffs wrote in the opening sentence of the suit. “This case is about the Board of Health, appointed by the mayor, bypassing the proper legislative process for governing the city.” [Legal experts think that cities do have the authority to regulate public health, witness smoking bans, helmet laws, and seatbelt requirements]
• The cap is a ban on personal freedom. [Nobody is stopping people from buying more soda if they want it]
• Most New Yorkers oppose the soda cap. [Perhaps because of the extraordinarily expensive campaign conducted by the soda industry]
• The cap is “arbitrary and capricious,” because it applies only to some businesses and targets only certain types of beverages: “Delis and hotdog stands are barred from selling a 20-ounce lemonade, but the 7-Eleven a few feet away remains free to sell Big Gulps.”  [The rule applies to all businesses over which the city has jurisdiction, so there is nothing arbitrary about it] 

This lawsuit is clearly about profits, not health.  Let’s hope the Court throws it out.

The first 14 of the documents are available in a zip file here (but only for the next week or so).

You have to hand it to BPI (Beef Products Inc), the producer of  “Lean Finely Textured Beef (LFTB)”—a.k.a. “pink slime.”  The company deserves a prize for chutzpah (translation: outrageous audacity).

It has just filed a defamation (“veggie libel”) lawsuit for $1.2 billion (!) against an amazing cast of characters:

• ABC News (owned by Disney)
• TV news anchor Diane Sawyer
• ABC correspondent Jim Avila
• ABC correspondent David Kerley
• Gerald Zirnstein , former USDA employee who invented the term “pink slime”
• Carl Custer, former USDA employee
• Kit Foshee, whistleblower former BPI employee

South Dakota, apparently, has a veggie libel law to protect companies making food products from people who say mean things about them (recall: the Texas cattlemen vs. Oprah Winfrey).  Nobody has ever tested the constitutionality of veggie libel laws but I don’t know anyone who thinks they will stand up in court—free speech and all that.

BPI says the company lost 80% of its sales, a loss of $20 million per month, following news broadcasts about “pink slime.”  It had to close three facilities—in Texas, Kansas, and Iowa—and fire 650 workers at those places as well as 85 others at the company’s headquarters in South Dakota.

As I’ve written before, I see the “pink slime” episode as reflecting a lack of transparency in the beef industry and BPI’s efforts to defend its products as an example of power politics in action.

BPI is fighting back, hard.

• It created its own website: Beef is Beef
• It got some congressional representative to get the Congressional Research Service to write a report on the “pink slime” episode.
• And now this lawsuit.

The responses:

ABC News says, “The lawsuit is without merit. We will contest it vigorously.”

Bill Marler, the Seattle attorney who specializes in representing victims of food poisonings, has taken on this case and is representing Custer and Zirnstein.

Marler points out:

• You can buy a lot of Pink Slime for $1.2 billion.
• Someone should have told BPI’s lawyer it is not a great PR move to repeat the same charge that your client is now claiming harmed them in the first place.
• The lawsuit is without merit.
• We intend to defend this bogus, unwarranted and frivolous claim brought by BPI against these two former FSIS public employees.
• We are also contemplating filing a counter-claim against PBI.

Let the charges and countercharges begin!

This one will be almost as much fun to watch as the equally absurd legal squabbles between the Sugar Association and the Corn Refiners Association over what to call High Fructose Corn Syrup.  I’ll do a post on that next week sometime.

I’m puzzled by the huge media attention to McDonald’s announcement that it will post calories on menu boards.

McDonald’s will have to do this sooner or later.  By doing it now, it gets a public relations bonus.

Why will it have to?  Because the Affordable Care Act takes menu labeling national (see my previous post on this).

When the Supreme Court ruled that the Affordable Care Act is constitutional, it made menu labeling constitutional.

The FDA wrote proposed rules for menu labeling early in April.  These, you may recall, contain exemptions for movie theaters and other venues.  Note: There is still time to file complaints about the exemptions.

Implementation of the rules can’t begin until the White House Office of Management and Budget releases them.  It’s had them—along with food safety and other regulations—under consideration for months.

Presumably, OMB will act eventually.

McDonald’s looks like a champion getting out in front on this one.

Other fast food places will have to post calories too.  The only question is when.

• DMAA does not naturally come from a food.
• Most of it is produced synthetically
• It might not be safe.