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By an act of Congress, dietary supplements are regulated less strictly than conventional foods, so much so that some beverage manufacturers would much prefer to have their products labeled as dietary supplements than foods, energy shots, for example.

Under the law, the FDA pretty much has to keep hands off of supplements, except when something egregious happens, like people getting sick or dying.

The FDA is now trying to clarify the difference between beverages that are supplements and those that are drugs.  It just issued:

• Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages
• Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
• Federal Register Notice for the Industry Guidance on Distinguishing Liquid Dietary Supplements from Beverages

These documents, however, are guidance.  The are not regulations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Why is FDA doing this?  I’m guessing for two reasons.

1.  The weird ingredients in energy drinks:

We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods. 

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.

2.  The high caffeine levels in those drinks.

Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

Caffeine is GRAS (generally recognized as safe) at the levels added to soft drinks.

But the levels in energy drinks are so much higher that the FDA has questions about whether GRAS applies to them.

These guidance documents are open for comment.  If you care about such issues, weigh in now.

In the strange way the U.S. government works, Congress has produced the “Consolidated Appropriations Act of 2014,” which authorizes payments for government services, including those related to agriculture.

This is not the farm bill.  It’s what Congress decides taxpayers will pay for in the farm bill as well as bills that cover other programs run by USDA.

The House summary of agriculture appropriations is a lot easier to read than the bill itself, although it contains its share of double speak.  Try this:

WIC – This program provides supplemental nutritional foods needed by pregnant and nursing mothers, babies and young children. The bill provides full funding for WIC at $6.7 billion – $153 million below the fiscal year 2013 enacted level…This level will ensure all eligible participants will be served.

Can someone please explain to me how a cut of $153 million will ensure service to everyone who is eligible?  WIC is not an entitlement; eligible people cannot be served once the money runs out.

The bill does provide full spending—$82.2 billion—for SNAP, but only because it has to.  SNAP is an entitlement and spending for it is mandatory.  Unless, of course, Congress ever passes the farm bill, which currently contains a $9 billion proposed cut.

And here’s more double speak.  “The legislation includes several provisions to reduce spending and increase oversight of taxpayer dollars.”  How?  By authorizing spending for:

• Oversight and monitoring requirements for the WIC program, including a directive for the Secretary of Agriculture to increase oversight of vendors to help rein in food costs;
• A provision requiring USDA to submit a plan for reducing high error rates and improper payments in the National School Lunch and School Breakfast Programs;
• Requirements for the Secretary of Agriculture to help weed out and eliminate waste, fraud, and abuse in the SNAP program – including a directive to ban fraudulent vendors, and a prohibition on advertisements or outreach with foreign governments.

And why does the FDA’s budget still get decided by committees dealing with agricultural appropriations?

The FDA is a public health agency in the Department of Health and Human Services, which is funded by entirely different committees which you might think understand its mission a lot better than committees fussing about legislation that

restricts the Grain Inspection, Packers and Stockyards Administration (GIPSA) from implementing certain regulations that would allow harmful government interference in the private market for the livestock and poultry industry.

I can hardly wait to see what the farm bill will look like.

I’ve written frequently about the “natural” issue—what’s natural in foods and what’s not—on this site and now must do so again.

Yesterday, FoodNavigator reported that the FDA “respectfully declined” to decide once and for all whether foods labeled “natural” can include GMOs.

To summarize what brought this on:

• Judge Yvonne Gonzalez Rogers referred a lawsuit over “all-natural’ claims on GMO-containing Mission tortilla chips to the FDA to decide whether GMO-containing products can be considered “natural.”
• So did two other judges in cases involving Campbell Soup and General Mills Kix cereal.

The FDA’s letter to the three judges says the agency has to make decisions like this in the context of rulemaking, not litigation.

So how about making a decision about what “natural” means once and for all?

Not a chance.  The FDA says it has better things to do:  “Because especially in the foods arena, FDA operates in a world of limited resources, we necessarily must prioritize which issues to address.”

Back to court, this one goes, or so it seems.

The New England Journal of Medicine has an editorial on why we need to stop using antibiotics to promote the growth of farm animals and make sure they are only used for therapeutic purposes.

Otherwise, bacteria will become resistant to them and the antibiotics won’t work in us.

This figure from the article illustrates the problem:

As writers in the Journal wrote a year ago, we know what to do about the problem: Ban antibiotic use for everything other than disease treatment.

The FDA is taking baby steps in this direction.  How about a new year’s resolution to speed up the process?

I was in Washington DC last week when the FDA announced  that it was taking significant steps to address antibiotic resistance, a problem caused by overuse in raising animals for food.

The FDA called on makers of animal antibiotics to:

• Voluntarily stop labeling medical important antibiotics as usable for promoting animal growth or feed efficiency (in essence, banning antibiotics from these uses).
• Voluntarily notify the FDA of their intent to sign on to these strategies within the next three months.
• Voluntarily put the new guidance into effect within 3 years.
• Agree to a proposed rule to require a veterinarian’s prescription to use antibiotics that are presently sold over the counter (the proposal is open for public comment for 90 days at www.regulations.gov.   Docket FDA-2010-N-0155).

Voluntary is, of course, a red flag and the Washington Post quoted critics saying that the new guidance falls far short of what really is needed—a flat-out ban on use of antibiotics as growth promoters.

• Consumers Union is concerned about the long delay caused by the 3-year window.
• CSPI is worried about all the loopholes.
• NRDC thinks the FDA is pretending to do more than it’s really doing and “kicks the can significantly down the road.”
• Mother Jones points out that the meat industry can still “claim it’s using antibiotics ‘preventively,’ continuing to reap the benefits of growth promotion and continue to generate resistant bacteria.”
• Civil Eats reminds us that the Pew Commission on Industrial Farm Animal Production (on which I served) recommended a ban on nontherapeutic use of all antibiotics.

Yes, the loopholes are real, but I view the FDA’s guidance as a major big deal.  The agency is explicitly taking on the antibiotic problem.  It is sending a clear signal to industrial farm animal  producers that sooner or later they will have to:

• Stop using antibiotics as growth promoters.
• Stop using antibiotics indiscriminately, even for disease treatment.

I think the FDA is dead serious about the antibiotic problem.  If the FDA seems to be doing this in some convoluted fashion, I’m guessing it’s because it has to.  The FDA must not have been able to find any other politically viable way to get at the antibiotics problem.

I see this as a first step on the road to banning antibiotics for any use in animals other than the occasional treatment of specific illnesses.

As the New York Times puts it,

This is the agency’s first serious attempt in decades to curb what experts have long regarded as the systematic overuse of antibiotics in healthy farm animals, with the drugs typically added directly into their feed and water. The waning effectiveness of antibiotics — wonder drugs of the 20th century — has become a looming threat to public health. At least two million Americans fall sick every year and about 23,000 die from antibiotic-resistant infections.

Still not convinced antibiotics are worth banning for promoting growth?

The best explanation is the Washington Post’s handy guide to the antibiotic-perplexed.  Here, for example, is its timeline of development of microbial resistance to antibiotics.  The bottom line: the more widespread the use of antibiotics, the greater the onset and prevalence of resistance.  And it takes practically no time for bacteria to develop resistance to antibiotic drugs.

Resources from FDA

• Consumer Update: Phasing Out Animal Antibiotics
• FAQ on today’s action
• Final Non-Binding Guidance for Industry 213
• Veterinary Feed Directive
• Final Non-Binding Guidance for Industry 209

At a talk I gave for CQ Roll Call in Washington, DC last week, an audience member asked about the definition of “natural.”  I thought I had said everything there was to say about it (see post from August).  Wrong.

Another member of the audience sent me the definition of “natural” produced by, of all things, the  Treasury Department’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

Three federal agencies deal with “natural.”

The FDA

In answer to the question, “What is the meaning of ‘natural’ on the label of food?,” the FDA says:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

The USDA

The USDA discusses “natural” in the context of organic foods, in order to distinguish “natural” from organic:

Natural. As required by USDA, meat, poultry, and egg products labeled as “natural” must be minimally processed and contain no artificial ingredients. However, the natural label does not include any standards regarding farm practices and only applies to processing of meat and egg products. There are no standards or regulations for the labeling of natural food products if they do not contain meat or eggs.

The ATF

This agency is in charge of regulating alcoholic beverages, largely for tax-collection purposes.  Its “ATF Ruling 85-4” does not actually define the term “natural,” but instead says when ATF takes no exception to its use.

(1) Any grape fruit, citrus or agricultural wine may be designated “natural” if it is made without added alcohol or brandy…No other type of wine may be designated as “natural.”

(2) A distilled spirit may be designated as “natural” if is solely the result of distillation, with or without mingling of the same class and type of spirits or simple filtration which does not alter the class or type of the product.

(3) A malt beverage may be designated “natural” if it is made without adjuncts (additives) other than those additives which do not remain in the finished product, either by precipitating out or by combining with other components of the product and the resulting compound precipitates or is filtered out.

I am not making this up.

CSPI thinks it’s time to phase out the use of “natural.”  OK by me.

Addition: Michele Simon, who blogs at Eat, Drink, Politics, writes (she’s not making this up either):

In fact, ATF is how housed within the Department of Justice.

Historically, ATF had all jurisdiction over alcohol (and was within Treasury), which is where that rule must have come from.

ATF still maintains jurisdiction over criminal activity, but now, the Alcohol and Tobacco Tax and Trade Bureau oversees labeling. That’s housed within Treasury.

This explains the split in 2002 (click here).

Clear as mud? So maybe you can add a fourth agency to your list!

Thanks to Politico for alerting us to Monsanto’s sudden discovery:  it has just recognized—can you believe this?—that it has a public image problem.

In recent months the company has shaken up its senior public relations staff, upped its relationship with one of the nation’s largest public relations firms and helped launch a website designed to combat the fallacies surrounding genetically modified organisms.

Monsanto revealed its public image worries in its annual filing to the Securities and Exchange Commission.  The SEC requires companies to list societal factors that create risk to its profitability. Monsanto’s first three:

1.  Threats to patent rights

Efforts to protect our intellectual property rights and to defend claims against us can increase our costs and will not always succeed; any failures could adversely affect sales and profitability or restrict our ability to do business.

Intellectual property rights are crucial to our business, particularly our Seeds and Genomics segment. We endeavor to obtain and protect our intellectual property rights in jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported.

2. Too much regulation

We are subject to extensive regulation affecting our seed biotechnology and agricultural products and our research and manufacturing processes, which affects our sales and profitability.

Regulatory and legislative requirements affect the development, manufacture and distribution of our products, including the testing and planting of seeds containing our biotechnology traits and the import of crops grown from those seeds, and non-compliance can harm our sales and profitability.

3. Bad public relations

The degree of public acceptance or perceived public acceptance of our biotechnology products can affect our sales and results of operations by affecting planting approvals, regulatory requirements and customer purchase decisions.

Some opponents of our technology actively raise public concern about the potential for adverse effects of our products on human or animal health, other plants and the environment. .. Public concern can affect the timing of, and whether we are able to obtain, government approvals.

Even after approvals are granted, public concern may lead to increased regulation or legislation or litigation…which could affect our sales and results of operations by affecting planting approvals, and may adversely affect sales of our products to farmers, due to their concerns about available markets for the sale of crops or other products derived from biotechnology.

Maybe if the company was less aggressive about defending itself against risks #1 and #2, public relations would be less of an issue.

Do the close calls on labeling initiatives in California and  Washington worry Monsanto?  Of course they do.  They should.

I was on the FDA food advisory committee in 1994 and witnessed Monsanto’s aggressive opposition to labeling.

If public image is a problem for the company, it has nobody to blame but itself. 

The only surprise:  Why did public demands for labeling take so long?

I’m in Washington, DC this week on a bit of book tour for Eat, Drink, Vote (see Appearances for schedule).

At my Politics & Prose bookstore event last night, I got asked why I think the food environment matters so much in dietary choice.  Isn’t food choice a matter of personal responsibility?

It is, of course, but the food environment greatly influences personal choice.

Two examples:

Large portions: just about anyone presented with a large portion of food with eat more from it, take in more calories (larger portions have more calories!), and underestimate the calories consumed by a much greater proportion than from a smaller amount.

Salt intake: Because 80% or so of salt in the American diet comes from processed and restaurant foods, people eating in restaurants have no control over the amount of salt they take in.

To make it easier for people to take in fewer calories and less salt requires changes in the food environment: serve smaller portions and reduce the salt in restaurant foods.

FDA: Get to work!