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FDA Archive

Food Law and Policy Weekly Review, February 2 – 6, 2015

February 9, 2015


  • Cornell announced a $712,000 in USDA grant for its Northeast Beginning Farmer Program. Part of the the funding will be dedicated to creating training programs and farmer-to-farmer networks for military veterans transitioning into agriculture. Services to be provided by the Farmer Veteran Coalition.
  • For our New York clients and friends, in the farming community, Farm Bureau of New York is pressing the state legislature for an investment tax credit that would reimburse farmers for their expenses on items that are considered an investment in their business, such as construction supplies, machinery and new technology. The credits are intended to support the efforts of young farmers in particular.
  • If you are a food business subject to regulation by the FDA, you might notice an increase in FDA inspections in 2016. That is because the FDA issued a press release outlining its $4.9 billion budget request for FY 2016. The rationale for the request is to implement the Food Safety Modernization Act. According to the press release, a portion of this budget will be earmarked for the hiring and training of new inspectors.
  • In 2015, certain restaurants will have to comply with FDA guidelines on nutrition labeling. A recent study has indicated that affluent customers are more likely to utilize the kind of information required by the regulations.
  • Natural Products Insider advises supplement manufacturers to have a robust game plan to defend against class-action lawsuits. They recommend manufacturers perform label review by an experienced attorney as part of the risk mitigation strategy. Good advice for food manufacturers as well, and label review is one of our core services.
  • Breyer Ice Cream announced it will no longer be using milk from cows given rBST, recombinant Bovine Growth hormone.
  • D.C. Circuit Court of Appeals agreed with a previous finding of the Federal Trade Commission that POM Wonderful made deceptive claims in its advertising.

FDA Prohibits Certain Omega-3 Claims

June 23, 2014

by Jack Hornickel

The FDA recently issued a final rule prohibiting the use of certain nutrient content claims regarding omega-3 fatty acids. After a lengthy review of proposed claims submitted by three companies, FDA refused to permit claims such as “good source of,” “high in,” and “fortified with” docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), while allowing certain claims regarding alpha-linolenic acid (ALA) content. The rule becomes effective January 1, 2016.

Fortified with . . . stench

Fortified with . . . stench

The reason for FDA’s decision is quite logical. Under the Food, Drug, and Cosmetic Act, food producers can request official permission to use nutrient content claims, accompanied by supporting research from the National Academy of Sciences or some other federal health authority. Among other requirements, the request must prove that the nutrient content claim accurately represents the scientific research. Because phrases such as “good source of,” “high in,” and “fortified with” clearly imply a better-than-average nutrient content, the scientific research must identify a daily reference value of the nutrient — in other words, how much of the nutrient we should have in our diets.

After reviewing the provided scientific research from the Food and Nutrition Board of the Institute of Medicine at the National Academy of Sciences, FDA was not convinced. The scientific authority, FDA decided, did not accurately identify a baseline nutrient level to which the claims referred. Thus, without an adequate scientific basis, the nutrient content claims do not convey meaningful information; rather, they mislead consumers.

Omega-3 fatty acids are found in a number of food products and ingredients: soy, walnuts, canola oil, flaxseed, hempseed, chia seed, liver, fish, eggs, algae, and seaweed. Omega-3s are widely believed to reduce inflammation, and risk of heart disease and cancer. Thus, while the new FDA rule seeks to protect consumers from the proverbial snake oil salesman, it leaves consumers to refer to sites such as veganhealth.org and DHAbaby.com for tips on what foods are a “good source of” omega-3s. Food manufacturers may continue to make accurate labeling claims identifying the omega-3 content of their products, such as “contains ___ mg of DHA omega-3 fatty acids per serving.”

FDA Clarifies Honey Labeling Requirements

May 1, 2014

by Gabriella Agostinelli

Americans consume more than 400 million pounds of honey each year, but only about 37% (149 million pounds) of this honey is actually produced in America.  Honey prices also hit a record high last year, costing us around $2.12 per pound. As honey prices are spiking and we increasingly rely on honey imports, American beekeepers and the FDA fear foreign producers are adulterating the product with cheap corn syrup and sugar.

honey-156826_640In response to pressure from the American Beekeeping Federation and several other related trade groups, the FDA has proposed new guidelines for clarifying the meaning of “honey” in food labeling. Under the new guidelines, food companies and other producers adding sweeteners to honey must notify consumers that a product is a “blend.” For example, a product containing mostly honey with added high fructose corn syrup should be labeled “blend of honey and high fructose corn syrup.”

The draft guidance does not address whether honey subjected to ultrafiltration or pollen removal still qualifies as “honey.” For now, the guidelines’ main focus is to prevent adulteration, contamination, or misbranding of the natural sweetener and to promote fairer trade.

While a step forward, the new guidelines may not satisfy honey purists. FDA declined to adopt a formal standard of identity for honey in regulations. And its guidelines are merely non-binding recommendations. They do, however, reflect the agency’s interpretation of the law and positions it is likely to take in enforcement actions. Honey producers already are required by law to identify all extra sweeteners in their products’ ingredient statements. If they identify the product only as “honey” and fail to list all of the ingredients, FDA can take enforcement action against the manufacturer for adulteration and misbranding.

FDA is accepting comments on the proposed guidelines until June 9, 2014.

Legal Tools for Food Hubs, Part 3: Planning to Minimize the Burdens of FSMA

April 11, 2014

by Lauren Handel

Food hubs and the farmers who supply them will be significantly impacted by the new regulations FDA is promulgating under the Food Safety Modernization Act (FSMA) — in particular, the rules relating to produce safety and preventive controls. The rules are only in draft form now, and new drafts are due to be released this June. So it remains to be seen exactly how the exemptions will be defined. We will be looking closely at what changes, if any, are made to the exemptions for small businesses. Businesses that might qualify for the exemptions also should pay attention and plan ahead to minimize their regulatory burdens to the extent possible.

Under both the preventive controls and produce rule, businesses will be exempt from all or most requirements if their annual food sales are below certain dollar amounts. Both rules provide a qualified exemption from most of the requirements if a business’s average annual food sales are less than $500,000 and if the majority of its sales are direct to consumers or to local retailers or restaurants. The preventive controls rule also provides a qualified exemption for “very small” businesses, meaning those with annual food sales less than $250,000, $500,000 or $1 million (FDA has not yet decided which limit to use). Also, if a farming business’s annual food sales do not exceed $25,000, it would be completely exempt from the produce rule.

What food sales count toward these limits differs under the two rules. For the preventive controls rule, all food sales of affiliated companies count. In other words, all food sales of separate food processing or handling facilities under common ownership or control will be counted toward the exemption limit. In contrast, for purposes of the produce rule exemptions, the relevant food sales are those of a “farm,” which is defined as a physical place. Thus, as the produce rule is currently drafted, a farming business with multiple farms in different locations might qualify for an exemption on one farm, but not another, depending on the relative food sales from each farm.

When the rules are finalized, small food and farming businesses should consider whether they can structure their businesses or operations to avoid taking on more of a regulatory burden than necessary. It may be possible for a food hub enterprise to keep various parts of the operation under separate ownership and control so that their total food sales will not be aggregated for purposes of determining whether any one facility is exempt from the preventive controls rule. Similarly, a farming business with more than one farm location should consider the exemption criteria when planning what crops to plant on each farm. Of course, such considerations will have to be weighed against business needs and practical concerns.

We will be monitoring this issue as the FSMA rules continue to take shape. If you would like to discuss strategies you might employ in your small food or farming business to plan ahead for FSMA, feel free to contact me or Jason at (888) 908-4959 or info@foodlawfirm.com.

Food Labeling: Do it Right The First Time

August 17, 2012

It is my pleasure to introduce fellow food law geek, Gabriella Agostinelli. Garbiella is a second year law student at SUNY Buffalo School of Law. She is originally from Rochester, NY, absolutely food obsessed, and she hopes to build a professional legal career celebrating food in all its forms. Her first contribution to the LLC contemplates the importance of accurate labeling for food products:

Just weeks after General Mills came under fire for allegedly “deceptive” marketing and labeling claims, similar controversy has now arisen for fellow food giant Hershey Co with its chocolate-syrup labeling. Months ago, the FDA issued a warning to the company that two of their products, Hershey’s Syrup+Calcium and its Syrup Sugar Free with Vitamin & Mineral Fortification, violated the Food Drug and Cosmetic Act. FDA claims that Hershey’s product labels bore nutrient content claims that did not meet the requirements to make the claims, in violation of 21 U.S.C. § 343(r)(1)(A). The products’ nutritional contents did not meet the guidelines warranting the use of a “plus” sign or the word “fortification.”

The FDA regulates a broad range of words food companies can use to market their products. Devices such as plus signs and words like “with” are referred to as “More” claims and their permissible use is described at 21 CFR 101.54(e). For example, producers can only use “more” claims when the food contains more than 10% of the recommended daily intake for the fortified nutrient. This is where Hershey’s dropped the ball.

To avoid further issues, Hershey’s recently changed the plus sign to “with” and has removed “fortification” from the other label.

If seasoned vets like General Mills and Hershey’s can mislabel, one can imagine the potential dangers small businesses could face when labeling their products. A corporate titan like Hershey’s can bounce back from a mistake like this and absorb the financial losses associated with recalling and rebranding. Smaller businesses have zero margin for error.

A good start it to check out the FDA’s Food Labeling Guide, which provides a summary of the required statements that must appear on food labels under federal laws and regulations. The FDA does not pre-approve labels for food products, so it has to be done right the first time around.

There is, however, no substitute for expertise. Food entrepreneurs have a compelling need to distinguish their products from their competitors. That can be done through better sourcing or different recipes, but the label is probably the most important interface they have with new customers. The label is the first chance they get to discuss the things that make them different. New food businesses, therefore, need to push the regulatory limits even more than established businesses, and labeling is a regulatory minefield. No marketing strategy for a food product can be complete without some level of labeling review by someone familiar with the mass of regulation that governs the words you can use on your product.