FDA Finalizes New Nutrition Facts and Supplement Facts Labels

The FDA today announced a major redesign of nutrition facts label for packaged foods - the first such update in 20 years.  

The new design will make the "calories" and "servings" information more obvious and include a new line for added sugar (in grams and as percent Daily Value).  It will also update serving sizes that are more in line with amounts that people actually consume.  

"Total Fat," "Saturated Fat," and "Trans Fat" will continue to be required but "Calories from Fat" is being removed.  

Vitamin D and potassium will be required on the label.  Calcium and iron will continue to be required.  Vitamins A and C will not be required but may be included.

The daily values for nutrients like sodium, dietary fiber and vitamin D will be updated.

An abbreviated footnote for the %DV.

Manufacturers will need to use the new label by July 26, 2018. However, manufacturers with less than $10 million in annual food sales will have an additional year to comply.



The supplement facts panel will also have minor updates to reflect the changes in the nutrition facts panel.

FDA Proposes Updates to Nutrition Facts Labels on Food Packages

The FDA proposed several changes to the Nutrition Facts label for packaged foods today.  The FDA also proposed to make corresponding updates to the Supplement Facts label on dietary supplements. 

Some of the changes being proposed by the FDA would:

• Require information about the amount of "added sugar" in a food product.
• Update serving size requirements to reflect the amounts people currently eat.  (For example, changing the serving size of ice cream from half a cup to a full cup.)
• Require the declaration of potassium and vitamin D.  Vitamins A and C would no longer be required on the label.
• Revise the Daily Values for a variety of nutrients such as sodium, dietary fiber and vitamin D.
• Remove "Calories from Fat" from the label.
• Update the format to emphasize certain elements.

The FDA also published an alternative format to test public interests.   The agency is accepting public comment on the proposed changes for 90 days before the new rules being finalized .  The new rules aren't slated to take effect for at least two years.

FDA Issues Guidance to Clarify Requirements for Beverages v. Liquid Dietary Suppelments

The FDA published two final guidance documents to help industry determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.

One of the guidances - Distinguishing Liquid Dietary Supplements from Beverages - describes the factors that characterize liquid products that are dietary supplements and those that characterize beverages that are conventional foods.  Such factors include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling and advertising.

The second guidance - Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements - reminds the industry of requirements in the Federal Food, Drug, and Cosmetic Act that apply to substances added to both conventional foods, such as beverages, and to dietary supplements.

Why does it matter whether a food is a beverage or a dietary supplement? 

All ingredients intentionally added to conventional foods or beverages are considered food additives.  Food additives must either be approved by the FDA, deemed generally recognized as safe (GRAS), or otherwise exempted.  A company may self-affirm the GRAS status of a food ingredient in its product(s).  It is not mandatory for the company to submit a self-affirmed GRAS report to the FDA, however, it must be prepared to do so upon the FDA's request.  Further, the costs associated with GRAS determinations can run upwards of $75,000 to $100,00 per ingredient.

Ingredients in a dietary supplement, on the other hand, have different requirements.  For example, if an ingredient meets one of the definitions of dietary ingredient and was used as a dietary ingredient prior to October 1994, no additional proof of safety is required.  Therefore, many companies may have used the dietary supplement route to market their liquid food products to save money.  However, the costs associated with complying with the more stringent good manufacturing practices (GMP) for dietary supplements, as well as their added post-marketing requirements (adverse event reporting and record keeping), can make it more expensive to market a dietary supplement vs. a beverage, in the long run.

Therefore, it is important to consider all the potential costs involved for regulatory compliance when a company decides whether to include a particular ingredient in its next liquid food product.

FTC takes actions against makers of weight-loss products

The Federal Trade Commission (FTC) announced enforcement actions against four companies the agency said used deceptive advertising claims to sell weight-loss products.   In total, the four companies - Sensa, L'Occitane, HCG Diet Direct and LeanSpa - have agreed to pay about $34 million for consumer redress. 

The FTC has also updated guidance for publisher and broadcasters on how to spot phony weight-loss claims when screening ads for publication.  “Gut Check: A Reference Guide for Media on Spotting False Weight-Loss Claims” describes seven weight loss claims that can’t be true and should prompt a “gut check” – a second look to make sure publishers are not running advertisements with claims known to be false.  The guide also contains advice on dealing with problematic areas like consumer testimonials and fine print disclosures.  The Gut Check guidance updates the Red Flag Bogus Weight-Loss Claims reference guide for media that the FTC first published in 2003.

Sensa sold a sprinkle-on food additive that promised users would lose weight without exercising.  Users paid about $60 for one-month supply of Sensa products, which were sold online and at retail chains that included Costco and GNC.  U.S. retail sales between 2008 and 2012 totaled more than $364 million, according to the FTC.  The FTC said Sensa used faulty science in its marketing to mislead consumers and ordered the company to return $26.6 million to consumers.  The case was filed against Sensa, its parent firm, and two individuals who was chief executive and co-owner of the company.

L'Occitane, which the FTC said had no evidence to back up the claim that its skin cream would slim down a person's body, will pay $450,000.  HCG Diet Direct, which marketed a human hormone for weight-loss treatments, will surrender about $7.3 million in assets.

The fourth company, LeanSpa, which marketed acai berry and colon cleanse supplements, was granted a suspended settlement from the FTC because the company's inability to pay.

Weight-loss products remain one of the FTC's top enforcement priorities.   Makers of weight-loss products should ensure that their product claims (including testimonials used) are truthful, not misleading and supported by scientific evidence.

FDA Regulates Keyword Searches on the Internet

The U.S. Food and Drug Administration recently sent a Warning Letter to M.D.R. Fitness Corp., a Florida-based researcher and manufacturer of nutritional supplements.  In the letter, the FDA alleges a number of problems, but the one that's catching attention concerns the company's website search engine.

According to the FDA, typing the keyword "cancer" or "diabetes" into the product search field located on the company's website brings up several products.  Because those products are associated with disease terms, the FDA said, the company is thus “implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases,” which make them unapproved new drugs.

In a previous case, the FDA used metadata as evidence of intended use involving another company's dietary supplement.  Metadata are similar to keyword association in that both are largely invisible to the public.  These recent cases indicate that the FDA is targeting word associations on product websites. 

FDA Issues Draft Guidance On New Dietary Ingredients

The FDA announced today that it has issued draft guidance clarifying agency expectations on new dietary ingredients (NDI) for industry.  The guidance addresses in question-and-answer format what qualifies as an NDI ("a dietary ingredient that was not marketed in the United States before October 15, 1994"), when an NDI notification is necessary, the procedures for submitting an NDI notification, the types of data and information that the FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification.

Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a NDI to their products.  However, in certain situations when the ingredient has been part of the food supply (and is still considered an NDI), an NDI notification to the FDA is not required if it has not been chemically altered for use in supplements.

Under the guidance, minor loss of volatile components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension do not chemically alter an ingredient.

However, the following are examples of processes that the FDA would consider to involve chemical alteration:

• A process which makes or breaks chemical bonds such as hydrolysis or esterification, unless the bonds created by the process are reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion.
• Removal of some components of a tincture or solution in water (e.g., by chromatography, distillation or membrane filtration), which changes the chemical composition of the mixture.
• Use of solvents other than water or aqueous ethanol (tincture) to make an extract.
• High temperature baking or cooking of an ingredient that has not previously been baked or cooked, unless the process causes only minor loss of volatile components with no other changes to the chemical composition of the ingredient.
• Changing the manufacturing method for an ingredient such that the chemical composition is significantly different (e.g., changes that alter the composition of materials used to make the ingredient, use of a different solvent, use of a chromatographic matrix instead of a passive filter).
• Application of nanotechnology that results in new or altered chemical properties of the ingredient.
• Changing agricultural or fermentation conditions to alter the chemical composition of the ingredient, such as by sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.
• Fermentation using a fermentation medium different from the one used to make conventional foods in the food supply (e.g., use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese).
• Use of a botanical ingredient that is at a different life stage than previously used (e.g., making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.)

The guidance also states that if the manufacturing process alter the chemical composition or structure of an "old" dietary ingredient, the resulting compound is probably an NDI and an NDI notification to the FDA would be required.  For example, using a solvent to prepare an extract from a "old" dietary ingredient creates a NDI because the final extract contains only a fractionated subset of the constituent substances in the original dietary ingredient.  In addition, changes that alter the composition of materials used to make the ingredient, such as using a different part of a plant (e.g., using an extract of plant leaves where the root extract from the same plant is an "old" dietary ingredient), would create a NDI.

The 53-page guidance document could greatly impact your business.  It is recommended that you read it carefully and discuss it with your legal and regulatory team. 

The FDA is inviting the public to submit comments about the draft guidance.  Although you can comment on any guidance at any time, to ensure that the agency considers your comments on the draft guidance before it begins work on the final version of the guidance, you should submit your comments by October 3, 2011.

For more information: Federal Register Notice for New Dietary Ingredient Notifications and Related Issues (link for submitting comments; Docket ID: FDA-2011-D-0376): http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0001.

FDA Issues New Food-Safety Regulations

The FDA published two new rules on Wednesday designed to give the agency more power to detain unsafe food and identify potentially hazardous imported foods. 

Under the first rule, FDA will be able to seize food that agents believe could have been processed in unsanitary or unsafe conditions and hold it for up to 30 days.  Previously, the agency could only hold food products if there was specific evidence it was adulterated and presented a serious threat to life.

The second rule requires anyone importing food or animal feed into the United States to tell the FDA if any country has blocked importation of the same product. This requirement will give the agency more information about imported foods, improving its ability to target foods that may be hazardous, officials said. 

The new reporting requirement will be administered through the FDA's existing system requiring prior notice of incoming shipments of imported food, established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The new rules were issued under the authority of the Food Safety Modernization Act, which was signed into law by President Obama in January.  The law gave the FDA greater authority to regulate the U.S. food supply. The law also gave the FDA the power to issue mandatory recalls for companies that did not voluntarily recall contaminated products.

Both new regulations are scheduled to take effect Jul 3, but the FDA will accept comments on them until Aug 3, according to notices published today in the Federal Register.

See:
May 5 Federal Register notice on new administration detention rule.

May 5 Federal Register notice on food import reporting rule

FDA Proposes Draft Menu and Vending Machine Labeling Requirements

The FDA releases documents today regarding proposed regulations for restaurants and vending machine operators to include nutrition details on their menus and vending machines, as part of a healthcare law passed last year.

The FDA proposed that certain restaurants and retail food establishments provide nutrition information for standard menu items, including food on display and self-service dishes.

The rules target restaurants with 20 or more locations, as well as other retail food outlets, coffee shops and convenience stores.  However, a notable exemption to the proposed rules are movie theaters.

The FDA also proposed that companies owning and operating 20 or more food vending machines would be required to provide calorie information in close proximity to the food item or selection button. 

The FDA is seeking public comment on the proposed rule for menu labeling for 60 days (until 06-06-2011). Comments on the proposed rule on vending machines may be submitted for 90 days (until 07-05-2011). The FDA plans to issue final rules before the end of 2011.

The documents may be downloaded here:
1. Food Labeling; Nutritional Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (pdf); docket number FDA-2011-F-0172

2. Food Labeling; Calorie Labeling of Articles of Food in Vending Machines (pdf); docket number FDA-2011-F-0171

President signs food safety legislation

President Obama signed into law Tuesday legislation that represents the first major overhaul of the nation's food-safety infrastructure since 1938.

The Food Safety Modernization Act moves the FDA away from its previous role of responding to adulterated food to a more modern one of requiring companies to stop contamination before it happens by looking for the places where things can go wrong and fixing them.

The Act also allows the agency to issue mandatory recalls and hire more food-safety inspectors.

The FDA will need to draft regulations to enforce the new law.

Some of the changes the Act puts into place:

	Before	Now
Surveillance	Under the FDA's original statute from 1938, the focus was on responding to adulterated food once it was discovered.	Under the new rules, the FDA's focus shifts to stopping outbreaks before they start, by requiring farmers to address places in production where contamination might occur and to require processors to implement written food-safety plans.
Enforcement	The FDA couldn't force a company to recall tainted food; it could only seek a voluntary recall.	When needed, the FDA can order the recall of tainted food.
Specific targets	The FDA had to treat all foods the same, despite the fact that some are more likely to become contaminated than others.	FDA can develop regulations that focus on the highest-risk foods, including fruits, vegetables and imports.
Inspections	The FDA was able to inspect fewer than 20% of domestic food facilities and 1% of foreign food imports. More than half of food facilities have gone five or more years without a federal inspection, according to a 2010 report from the Health and Human Services inspector general.	The FDA will be able to hire 2,500 more field safety inspectors and food-safety experts by 2014 and increase substantially domestic and foreign inspections. The riskiest domestic facilities will be inspected every three years, beginning in 2015.
Records checks	For most plants, when the FDA conducted an inspection, it could only require a spot check of what was happening that day.	The FDA will have access to the food-safety plan, records and test results that are linked to the safety plan.
Exemptions	Big and small farms and producers were treated the same under the statute.	Farmers who primarily sell to farmers' markets or to restaurants, and who sell less than $500,000 a year, don't have to follow the new regulations.

Dannon fined for making health claims for its yogurt product

The Dannon Company will pay a $21 million fine and stop making exaggerated health claims for two very popular Dannon products under an agreement with the federal government and attorneys general from 39 states.

Dannon will stop claiming that one daily serving of Activia yogurt relieves irregularity and that its DanActive dairy drink helps people avoid catching colds or flu, the Federal Trade Commission announced on Wednesday.

"These types of misleading claims are enough to give consumers indigestion," says FTC Chairman Jon Leibowitz. "Companies like Dannon shouldn't exaggerate the strength of scientific support for their products."

The move signals a more aggressive federal watchdog roll over deceptive advertising practices by major marketers under the Obama administration

The FTC charged that Dannon's ads were deceptive because it did not have substantiation for its claims. The commission also charged that Dannon's claims that Activia and DanActive were clinically proven were false.

The FTC complaint and settlement can be downloaded from the FTC website at: http://www.ftc.gov/opa/2010/12/dannon.shtm. 

Here are some tips on substantiation of product claims: http://business.ftc.gov/documents/substantiation-science-compliance.

FDA issues warning letters to makers of caffeinated alcoholic beverages

The FDA today issued warning letters to four companies that make caffeinated alcoholic beverages.  This came nearly a year after the agency asked 30 manufacturers to provide their rationale, and supporting data and information, for concluding that their use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned.

“FDA does not find support for the claim that the addition of caffeine to these  alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

According to the FDA, its action follows a scientific review by the Agency.  FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers.  FDA also performed its own independent laboratory analysis of these products.

Although the warning letters were sent to only four companies who did not respond to the agency's letter last year that asked for the safety data, it appears that the agency is on the path to ban all caffeinated alcoholic beverages.

Latest regulatory trends from RAPS conference

There were several excellent speakers at the RPAS (Regulatory Affairs Professionals Society) annual conference in San Jose last week.  They represented regulatory professionals in the private and public sectors, both domestically and abroad.  Here are some of the take-away messages from the speakers:

• FDA is stepping up enforcement.  This shouldn't come as a surprise if you've been following the agency's enforcement actions lately.  In his speech to the food and dietary supplement industry, FDA's Chief Counsel Ralph S. Tyler stated that the agency has just began its enforcement efforts and that more are yet to come.  Among the areas of concern are the good manufacturing practices (GMP) regulations for dietary supplement products, as well as the notification requirements for new dietary ingredients.  The agency also intends to hold individual more accountable for violations, which would result in more criminal prosecutions of company executives and even employees.
• FTC is stepping up enforcement.  Similarly, the FTC is stepping up enforcement in the area of claim substantiation.  The FTC will be looking at scientific data more closely to determine whether they support claims made about a product.   Companies should pay more attention to testimonials, because according to the government, they are never substantiated. 
• Companies are very interested in the Chinese market, but are frustrated by the regulatory framework there.  Among the conference speakers were five officials from the Chinese State FDA (SFDA), who provided an overview of the medical device approval process in China.  This presentation was one of the popular ones at the conference, and the numbers and types of the questions asked at the end of the presentation showed many companies (large and small) are very interested in the Chinese market, and yet are frustrated with the lack of transparency in the approval process.  Here are some of the policies that can cause frustration:
• According to a SFDA official, if a foreign company manufactures a medical device in China, the company will have to export the finished product out of China.  However, if a Chinese company puts its own label on the same product, it will be able to sell the device in China.  This policy seems to have little to do with safety and efficacy.  
• Also according to the same official, a medical device imported into China will not receive SFDA approval if the device has not received market approval in the country of origin.  The message seemed to be: if this device is not good for your country, it's not good enough for China.
• Questions were asked about whether the SFDA would accept data from clinical trials done outside of the China.  The answer was as clear as water - generally no, but we will decide on a case by case basis, but if we decided you need to do more clinical trials, you need to conduct them in China.  
• Questions were asked about whether the SFDA would meet with companies to discuss their products before the companies submit their applications for approval of their products.  The answer was that the SFDA holds a "open forum" every Thursday during which anyone can participate in a Q&A session with the agency to discuss any regulatory issues.  According to the SFDA official, no appointment is required and people can participate by phone.  So much for confidentiality. 

I am still reviewing my notes and materials from the conference, and plan to blog about other interesting topics I ran across there.

Caffeine and Alcohol, conventional mix or beverage from hell?

Last November, the FDA notified nearly 30 manufacturers of alcoholic beverages containing added caffeine that it intends to look into the safety and legality of their products.  The FDA requested that each manufacturer provide its rationale, and supporting data and information, for concluding that its use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned, within 30 days of the notice.

The Pittsburgh Post-Gazette published a follow-up report on the FDA's inquiry today.  Nearly a year later, 19 of the 27 companies have responded, including some who asked for more time.  Apparently, the FDA is still evaluating this issue "as quickly as possible" but "a decision regarding the use of caffeine in alcoholic beverages could take some time."

An ingredient added to food (other than dietary supplements) is a food additive, which requires pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition.  However, a substance is exempt from the definition of a food additive (and exempt from pre-market approval) if it is GRAS. 

For a particular use of a substance to be GRAS, there must be both (1) evidence of safety, and (2) a basis to conclude that this evidence is generally known and accepted by qualified experts. 

Doctors and state attorney generals have presented their "anti-GRAS" studies showing that those who use caffeinated alcohol beverages drink more often, binge drink more often and are more likely to engage in risky behavior such as driving with a drunk driver.

It would be interesting to see the outcome of this case as well as the basis of these manufactures' GRAS determination, if any.  Rum and Coke, anyone?

The Fed took action against unapproved "drug" manufacturer

The federal government has barred a Montana company from the manufacture and sale of unapproved new drugs and dietary supplements, the FDA announced this week.  The order came in the form of a consent decree, filed in U.S. District Court for the District of Montana Wednesday and subject to court approval.

According to the FDA, the company manufactured and distributed a variety of unapproved new drugs that "were ineffective in treating the diseases they claim to treat."

The products - sold under such names as Black Salve, Cancema and Can-Support -- included topical salves purported to treat skin cancer, and oils and capsules to combat "serious diseases such as breast cancer, asthma, anemia and epilepsy," according to the FDA.

The FDA characterized many of these products as dietary supplements.
"The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers," Autor said. "The FDA is committed to ensuring that consumers do not become victims of false cures."

In signing the consent decree, the company agreed to stop making and selling unapproved new drugs and products with unauthorized health claims and to hire an independent expert to review claims made for any future products, according to the statement.

Had the company hired an independent expert to review claims made for their products before they put them on the market, I suspect they would not have ended up in such deep trouble.

FDA revised selenium health claims, but would you want to use them?

Alliance for Natural Health US, a trade group who sued the FDA after the agency denied their health claim petition, announced last week that it has reached a partial settlement with the FDA regarding the case.

According to Natural Products Insider, the following claims may now be used on labels and in labeling of selenium-containing dietary supplements in the U.S. effective immediately:

• "Selenium may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of prostate cancer."
• "Selenium may reduce the risk of colon cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of colon cancer."
• "Selenium may reduce the risk of bladder, colon, prostate, and thyroid cancers. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers."

Previously, one the claims read: "Two weak studies suggest that selenium intake may reduce the risk of prostate cancer.  However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer."

The trade group asserted that the FDA's previous claim is at odds with the Supreme Court's mandate that there be a "reasonable fit" between the government's goal (of protecting public health and preventing consumer fraud) and the restrictions it imposes on commercial speech.  Specifically, the agency re-wrote the trade group's proposed claim, instead of inserting an appropriate disclaimer after it.  The new claims appeared to remedy that issue.

Although the new claims are shorter and can get the point across more directly, one has to wonder who would put the statement "FDA concludes that it is highly unlikely that" the claim is true on their products.

FTC has no business regulating speech from the heart, says POM Wonderful

Last week, the Federal Trade Commission (FTC) charged POM Wonderful, the maker of a brand of pomegranate juice, with making unsubstantiated health claims about its products.

The federal agency said the juice and supplements firm made "false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction."  The complaint says the company "violated federal law by making deceptive disease prevention and treatment claims" with ads in the New York Times and other publications and on the Internet.

In an editorial published by the LA Times, Michael Hiltzik takes a closer look at POM's reactions to the charge, as well as the scientific research, which was funded by the company, behind the health claims.

It is not surprising that the people at POM are outraged by the charge and content that the federal government is infringing on their right of free speech.

The most interesting part of the editorial is perhaps POM's assertion that the company owner's (Lynda Resnick) statements about the product should not be taken as an "advertisement" and that since they were made in an interview, they are none of the FTC's business.

According to POM, Resnick is "talking about what she personally believes with respect to the science that she's seen. ... Lynda's not a doctor, she's not offering scientific opinion; she's speaking ... as an individual from the heart about what she believes."

A company generally cannot have someone say something for the company that it cannot say under FTC or FDA regulations.   Like Mr. Hiltzik, I am interested in seeing whether POM Wonderful can make that argument stick with the FTC.