January 15, 2010
FDLI Food Hot Topics, Jan 27-28, 2010, Washington DC
From the Food and Drug Law Institute website:
Not your typical food program, these four, half-day workshops are designed for intermediate level professionals in the food and dietary supplement industries. This is your opportunity to interact with the experts in a small setting focused on critical issues affecting food and dietary supplement law and regulation. Register for one or all four programs!
January 27, 2010
- FDA Enforcement of the New Dietary Supplement GMP’s and What it May
Portend to the Conventional Food Industry if Congress Passes Food Safety
- Food Advertising and the National Advertising Division
January 28, 2010
- The Future of Food and Dietary Supplement Recalls
- Claims Substantiation and Fraud Issues
Post by Donna M. Byrne, Professor of Law, William Mitchell College of Law
December 08, 2009
Liquid Dietary Supplement vs. Beverage -- FDA Guidance
What is a beverage? Beverages are conventional foods that should not be marketed as dietary supplements. And dietary supplements are not supposed to be represented as conventional foods. It's a matter of getting the product, the label, and the marketing plans to line up on the same side of the line. The line is blurry. FDA released draft industry guidance yesterday to help make it clearer:
. . . The Food and Drug Administration (FDA) has observed and become concerned about two trends in the marketing of beverages. First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods. Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement in section 201(ff) of the FFDCA (21 U.S.C. 321(ff)) and must meet the regulatory requirements that apply to conventional foods.
Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts. Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients 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 ingredients are unapproved food additives when used at higher levels or under other new conditions of use. Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.
October 30, 2009
FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C
The U.S. Food and Drug Administration [Friday, Oct. 30] sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:
- To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and
- Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.
Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.
(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)
For more information
FDA Warning Letter to Procter & Gamble
October 03, 2009
Dietary Supplement Labeling Guide
Here's a nifty table showing some of the differences between dietary supplement labeling rules and conventional food labeling rules. The table is presented on Food Label News, an online newsletter by Food Consulting Company, which provides nutritional analysis and labeling advice. From their labeling guide:
A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet; “dietary ingredients” include: vitamins, minerals, herbs/botanicals, amino acids, enzymes, organ tissues, glandulars, metabolites, extracts or concentrates. Dietary supplements have many forms: . . .
August 18, 2009
Dietary Supplements Lawsuit Over FDA Regulations
From FDA Law Blog:
Alliance for Natural Health Sues FDA to Invalidate Dietary Supplement CGMPs By Ricardo Carvajal & JP Ellison –
It’s been a busy month at the Alliance for Natural Health. In addition to suing FDA over its handling of health claims, the Alliance (in conjunction with other plaintiffs) has sued FDA to invalidate certain provisions of the agency’s Current Good Manufacturing Practice (“CGMP”) regulation for dietary supplements. In part, the complaint maintains . . .
August 05, 2009
Bill Would Provide Tax Breaks for Buying Dietary Supplements
Press Release from Congressman Earl Blumenauer's website:
Thursday, 30 July 2009 Washington, DC—Representatives Earl Blumenauer (D-Ore) and Ginny Brown-Waite (R-Fla) today introduced bipartisan legislation that will make those vitamins, wellness and nutritional supplements eligible for FDA-approved health claims more affordable by allowing employees to purchase them using pre-tax dollars already reserved for health needs.
“Fitness, preventive care, good eating, and vitamins keep us healthier longer – and often out of the doctor’s office,” said Rep. Blumenauer. “As we in Congress work to reform our broken health care system, there are small, common sense steps we can take to save money and reduce unnecessary visits to the doctor. Nutritional supplements can significantly improve health, and by making vitamins and supplements more affordable, we can help people stay healthy while reducing medical costs.”
Needless to say, the tax break would not extend to purchases of fresh fruits and vegetables, as these are not eligible for FDA-approved health claims. DMB
July 30, 2009
From the New York Times
Federal regulators warned consumers on Tuesday not to use body-building products that are sold as nutritional supplements but may contain steroids or steroidlike substances, citing reports of acute liver injury and kidney failure. . . .
Generally, the F.D.A. said, buyers should beware of body-building products that claim to enhance or diminish the effects of hormones like testosterone, estrogen or progestin. In particular, the agency said consumers should not buy products labeled with code words like “anabolic” and “tren,” or phrases like “blocks estrogen,” and “minimizes gyno.”
July 16, 2009
FDA: Industry Guidance on Adverse Event Reporting for Dietary Supplements
From the Introduction:
This document provides guidance to the dietary supplement industry for complying with the adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469). As required by section 3(d)(3) of this law, we are issuing guidance to describe the minimum data elements for serious adverse event reports for dietary supplements. We are also providing guidance on (1) how, when, and where to submit a serious adverse event report for a dietary supplement; and (2) records maintenance and access for serious and non-serious adverse event reports and related documents. A separate guidance has been issued on the reporting of serious adverse events for over-the-counter (nonprescription) human drug products marketed without an approved application.
An article summarizing the guidance is available on nutraingredients-usa.com.
July 13, 2009
From Food Ingredients Online (although I'm not sure this is really a food ingredient. I don't quite know what chromium picolinate is!):
. . . In its safety assessment, the EFSA concluded that chromium picolinate does not present a safety concern when used as a source of chromium in food supplements. This assessment is an initial step in the procedure for the formal EU approval of chromium picolinate as an acceptable form of supplemental chromium.
. . .
Chromax chromium picolinate is Nutrition 21's top selling nutritional supplement ingredient in the U.S.
September 19, 2008
Prenatal maternal diet affects asthma risk in offspring
A recent study published in the Journal of Clinical Investigation suggests that a mother's use of folic acid supplements during pregnancy may contribute to development of asthma in her children. This was a mouse study that sought to test the notion that changes in the mother's diet could cause "changes in DNA methylation resulting in aberrant gene transcription" resulting in development of allergic airway disease in the child.
Here's how HealthDay describes the study:
The study, by researchers at National Jewish Health and Duke University, found that pregnant mice fed diets high in supplements containing methyl-donors (folic acid, L-methionine, choline and genistein) had babies with more severe allergic airway disease than mice born to mothers that consumed diets low in methyl-containing foods.
The mice born to mothers fed high methyl-donor diets had greater asthma severity, more airway hyperactivity, more allergic inflammation in the airways, higher levels of IgE in their blood, and their immune system T-cells were more likely to be the type associated with allergy. Male offspring also transmitted a higher predisposition to allergy airway disease to their pups.
The current issue of the Journal of Clinical Investigation also includes an editorial, Prenatal maternal diet affects asthma risk in offspring, by Rachel L. Miller:
. . .One cannot ignore the observation that the increase in asthma prevalence over recent decades approximately coincides with worldwide campaigns that recommend periconceptional dietary folate supplementation. From a public health perspective, the adverse nonrespiratory health consequences of insufficient prenatal folate consumption are legitimate concerns. But an even broader public health issue has surfaced. If confirmed, prenatal exposures may influence the development of asthma not only for our children, but for their children as well.
Here is the study: In utero supplementation with methyl donors enhances allergic airway disease in mice, by John W. Hollingsworth, Shuichiro Maruoka, Kathy Boon, Stavros Garantziotis, Zhuowei Li, John Tomfohr, Nathaniel Bailey, Erin N. Potts, Gregory Whitehead, David M. Brass and David A. Schwartz.
In 1996, the FDA required folate fortification of many flours and flour products in order to prevent spina bifida and other neural tube defects:
In keeping with the recommendations of PHS and the FDA Food Advisory Committee called to study these issues, the Food and Drug Administration is requiring that folic acid be added to specific flour, breads and other grains. These foods were chosen for fortification with folate because they are staple products for most of the U.S. population, and because they have a long history of being successful vehicles for improving nutrition to reduce the risk of classic nutrient deficiency diseases.
These fortified foods include most enriched breads, flours, corn meals, rice, noodles, macaroni and other grain products.
[For what it's worth, I refused to take folic acid supplements, but I made sure I got the full RDA by eating fortified cereal while I was pregnant. My kids both had childhood asthma (but then, I have asthma too).] DMB
February 09, 2008
JUNK FOOD LEADS TO PRISON?
Oxford University Professor John Stein and a team of scientists plan to study the whether the increase in the consumption of junk food in the last fifty years has lead to more violent behavior in young adults. From a January 29, 2008, article in The Independent:
Professor Stein and “[t]he university will lead the £1.4m study in which
1,000 males aged 16 to 21 from three young offenders' institutions in England and Scotland will be randomly allocated either the vitamin-and-mineral supplements or a placebo, and followed over 12 months.”
In a pilot study of 231 prisoners by the same researchers, published in 2002, violent incidents while in custody were cut by a more than a third among those given the supplements. Overall, offences recorded by the prison authorities fell by a quarter.”
Link to press release from the research charity the Wellcome Trust.
Thank you to William Mitchell College of Law student Matthew Dudas for preparing this post.
October 15, 2007
Dietary Supplements Siezed because of health claims
From an FDA news release:
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized on Tuesday approximately $71,000 of goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.
Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims are evident in the products' labeling, including promotional literature and FulLife's Internet Web site.
The agency takes seriously its responsibility to protect Americans from unapproved drugs. FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. Tuesday's action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.
June 25, 2007
FDA Issues Dietary Supplements Final Rule
The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.
Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.
The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.
The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.
April 12, 2007
Cocaine Energy Drink: Food, Drug, or None of these?
From ABC News:
[An energy drink -- "Cocaine" --] contains no actual cocaine, but is being marketed as "The Legal Alternative" to the illegal drug, according to its Web site. Its logo appears to be spelled out in a white powder that resembles the drug.
The Food and Drug Administration said Redux Beverages LLC is illegally marketing the drink as both a street drug alternative and a dietary supplement, according to a warning letter dated April 4 but publicly released Wednesday. The FDA cites as evidence the drink's own labeling and Web site, which include the statements "Speed in a Can," "Liquid Cocaine" and "Cocaine — Instant Rush," according to the letter.
February 24, 2007
Functional Foods in Europe
From NPICenter: A food supplement industry group, the European Botanical Forum, has recently developed a safety evaluation model for possible use in used in future regulation of botanicals under food law.
Botanicals include fruit and vegetables, herbs and spices, herbal teas and infusions, herbs added to foods and beverages for taste or functional purposes and botanical food supplements. Many botanicals however, also have medicinal uses, making the task of determining which legal framework applies to which product difficult.
“Safety is key,” stated Dr Manfred Ruthsatz, Chairman of the European Botanical Forum. “The aim of the negative list is to provide a document that is widely acceptable across the 27 EU member states to allow safe applications under food law on the principle that if there is no safety risk there should [not] be any regulation. The inclusion of botanicals into negative lists, however, should be considered with care since it would preclude use of the botanical entity for all food applications whereas the safety of derivatives, extracts or isolates can be frequently demonstrated.”
The model is a response to European Parliament action last Spring regarding Functional Foods and nutritional supplements. More on European functional foods regulation: Herbalgram.org
January 15, 2007
The 2006 Dole Spinach E. coli 0157:H7 Outbreak of 2006 on MarlerBlog
Bill Marler has posted an article on his Marler Blog detailing the developments of the 2006 bagged spinach E. coli 0157:H7 outbreak and placing the outbreak in the context of earlier produce-related E. coli outbreaks.
E. coli O157:H7 outbreaks associated with lettuce or spinach, specifically the "pre-washed" and "ready-to-eat" varieties sold under various brand and trade names, are by no means a new phenomenon. . . .The Center for Science in the Public Interest found that, of 225 food-poisoning outbreaks from 1990 to 1998, nearly 20 percent (55 outbreaks) were linked to fresh fruits, vegetables, or salads.
Last fall's spinach-sourced E. coli 0157:H7 outbreak, was traced to spinach grown by Natural Selection Foods (aka Earthbound Farm) and marketed by Dole, according to the article. This makes me realize how truly ignorant I am. Natural Selection Foods provides produce to some 20 different labels. Were all the tainted samples Dole because the unlucky lot of spinach happened to be going to Dole? Does Dole have any role in the actual packaging? So much yet to learn!
December 17, 2006
Blurring the Food-Drug line: Nestle buying unit of Novartis
Whatever happened to real food? Food giant Nestle is adding to its ability to sell products that kind of look like food, but have the characteristics of nutritional supplements. Nestle has agreed to buy a unit of Novartis, one of the largest makers of nutritional supplements. Earlier this year Nestle bought Jenny Craig and Uncle Tobys, a cereal bar producer.
This move makes sense as the baby boom generation ages and medical problems increase. This new acquisition will make Nestle the second largest maker of nutritional supplements for hospitals.
Sales of nutritional food are increasing as much as 8 percent a year, compared with 1 percent to 2 percent for the broader food market, according to Kepler Equities. Nestle has sold divisions valued at more than $1 billion that process cocoa and coffee and make food ingredients.
The Novartis unit makes Boost drinks, designed to bring proteins, minerals and vitamins to people with ailments ranging from anorexia to cancer and to aid digestion. It also makes Nutrament energy-drink and Optifast weight-loss products. It has 2,000 employees and operates in 40 countries.