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FDA was Busy in 2013 and its Sleigh is Packed Heading into the New Year

While often rightly the subject of criticism for delay or inaction on important regulatory matters, FDA in late 2013 has been bustling.  The FDA, during the second Obama term, has been pursuing a very aggressive regulatory agenda.  In addition to the widely discussed FSMA regulations (e.g., FSMA LIVES…..FDA Tells Food Importers How It Wants Them To Verify the Safety of the Foods They ImportFDA Proposed Reg will be “Game Changer” for Auditing and Certification OrganizationsFDA Released its Proposed Animal Food Rule: What’s in it?), notable examples include:

  • Trans Fat/PHOs

Based reportedly on new scientific evidence and the findings of expert scientific panels, FDA in early November published notice of its tentative determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for any use in food.  PHOs are the primary dietary source of industrially-produced trans fat.

A partially hydrogenated oil is formed when hydrogen is added to a vegetable oil (a process called hydrogenation) to make it more solid.  PHOs are used by food manufacturers to improve the texture, shelf-life, and flavor stability of foods.  PHOs and, therefore, trans fat, are found in baked goods, such as cakes, cookies and pies; snack foods, such as microwave popcorn; some fast foods; coffee creamer; vegetable shortenings; refrigerator dough products, such as biscuits and cinnamon rolls; and certain other products.

Trans fat consumption has been linked to an increased risk of coronary heart disease (CHD).  To address this health concern, FDA proposed in 1999 that manufacturers be required to declare the amount of trans fat in a food’s Nutrition Facts.  That requirement became effective in 2006.  The Centers for Disease Control and Prevention more recently estimates that a further reduction of trans fat in the food supply would prevent, each year, an additional 7,000 deaths from CHD and up to 20,000 heart attacks.  FDA agrees with expert groups, such as the Institute of Medicine and the American Heart Association, that trans fatty acids have a stronger effect on CHD risk than saturated fatty acids.

In light of the health risks associated with the consumption of trans fat, FDA is proposing that PHOs be regulated as food additives, rather than as self-affirmed GRAS ingredients.  If finalized, this would mean that food manufacturers would no longer be permitted to sell PHOs, either directly or as an ingredient in another food product, without prior FDA approval for use as a food additive.

The comment period on the proposal presently is scheduled to close on March 8, 2014.

  • Off-Label Drug/Device Use – Statements to the Financial Community

In a sharply worded Warning Letter dated November 8, 2013, FDA’s Office of Prescription Drug Promotion (OPDP) took the position that statements made by the CEO of Aegerion Pharmaceuticals, Inc. on episodes of a CNBC investment talk show, “Fast Money,” constituted representations that a company drug product, Juxtapid capsules, was intended for a use not approved by FDA.  This being the case, such statements rendered the drug misbranded by reason of not bearing adequate directions for use (for the unapproved use).

“Off-label” use of a prescription drug or medical device refers to the ability of licensed health care providers to prescribe or use the drug/device for indications, conditions, patients, dosages or routes of administration not yet evaluated and approved by FDA.  The decision to prescribe a prescription drug or use a medical device off-label typically is based on emerging science and clinical evidence, and may or may not differ from the evidence used for FDA to approve the product’s usage in the marketplace.

The Warning Letter (and its aftermath) merit monitoring not only because it represents the first OPDP Warning Letter taking issue with broadcast statements aimed at the financial community, but also because of its apparent juxtaposition with a recent federal appellate court decision (U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012)), essentially holding that representatives of pharmaceutical manufacturers have a right under the First Amendment to make truthful statements regarding their products, even if such statements indirectly promote drugs for uses not approved by FDA.

  • Antibacterial Soap

In mid-December, FDA published a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.  The proposed rule would amend a 1994 tentative final monograph for these over-the-counter (OTC) antiseptic drug products.

Millions of Americans use antibacterial hand soap and body wash products.  Although consumers generally view these products as effective tools to help prevent the spread of germs, FDA believes there is no current evidence that they are any more effective in preventing illness than washing with plain soap and water.  Further, some data suggest that long-term exposure to certain active ingredients used in these antibacterial products — for example, triclosan (in liquid soaps) and triclocarban (in bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.

The comment period on the proposed rule is scheduled to close in June 2014.  Thereafter, the requirements of the ensuing final rule would become effective one year following its publication.  If companies do not demonstrate the safety and effectiveness of their antibacterial hand soaps and body washes, these products would need to be reformulated or relabeled to remain on the market.

  • Animal Feed Antimicrobials

In mid-December, FDA began implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. The plan will also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.  The plan focuses on those antimicrobial drugs that are considered medically important (i.e., are important for treating human infection), and that are approved for use in feed and water of food animals.

Certain antimicrobials historically have been used in the feed or drinking water of cattle, poultry, hogs, and other food animals for “production” purposes (e.g., using less feed to gain weight).  Some of these antimicrobials are important drugs used to treat human infection, prompting concerns about the contribution of this practice to increasing the ability of bacteria and other microbes to resist the effects of a drug (e.g., antibiotic resistance).  Once antimicrobial resistance occurs, a drug may no longer be as effective in treating various illnesses or infections.

In a guidance document issued on December 11th, FDA laid out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these antimicrobial products to remove production indications.  The plan also calls for changing the current OTC status to bring the remaining appropriate therapeutic uses under veterinary oversight.  Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs may no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.  FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months.  These companies would then have a three-year transition period.

  • Acrylamide

Acrylamide is a chemical that can form in some foods during high-temperature cooking processes, such as frying, roasting, and baking.  On November 15, 2013, FDA announced the release of a new draft guidance document, Guidance for Industry: Acrylamide in Foods. The draft guidance provides FDA’s current thinking on procedures that can be used by various sectors of the food industry, including farmers, food processors, and restaurants, to reduce the level of acrylamide in a number of food products.  While acrylamide can form in a large variety of foods, the draft guidance document is focused on potato products (e.g., french fries and potato chips) and cereal grain-based products (e.g., breads, crackers and breakfast cereals).  The document also includes recommendations on cooking/preparing frozen french fries, as well as appropriate techniques for reducing acrylamide in potato and cereal-based foods for food service operations.

The draft guidance document is meant to suggest a range of possible approaches to acrylamide reduction, rather than to identify any specific approach as appropriate.  Nevertheless, FDA recommends that manufacturers evaluate and consider adopting acrylamide reduction approaches relevant to their products, if feasible.  FDA also recommends that manufacturers be aware of acrylamide levels in their products; however, at this time, FDA is not recommending specific limits or action levels for acrylamide or acrylamide precursors.  FDA will continue to monitor acrylamide levels in food to determine if reductions occur over time.

  • GMO Salmon

Nearly a year ago, FDA issued an environmental assessment and finding of no significant impact for Aqua Bounty’s genetically engineered salmon.  The agency is expected to formally approve the product in early 2014.

  • Spice Safety

In November, FDA issued a draft risk profile on pathogens in spices that concluded most imported spices are twice as likely to host salmonella than other imported foods.  Comments are due in March 2014.

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FDA clearly has much afoot as it heads into the New Year.  OFW Law will help cover it for you.

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