miércoles, 8 de junio de 2016

FDA Law Blog: FDA Rolls Out Sodium Reduction Initiative, and Salt Remains GRAS

FDA Law Blog: FDA Rolls Out Sodium Reduction Initiative, and Salt Remains GRAS

Posted: 07 Jun 2016 07:58 PM PDT
By Jenifer R. Stach & Ricardo Carvajal –

Carrying through on what had been designated as a high priority item, FDA rolled out its sodium reduction initiative with several actions, all on the same day.  On June 1, 2016, FDA published a Federal Register notice to announce the availability ofdraft guidance, held a same-day webinar (see slides here), issued a response letter denying a 2005 citizen petition submitted by the Center for Science in the Public Interest (CSPI), and updated the FDA Voice blog with a post by CFSAN Director Susan Mayne, Ph.D.

The draft guidance, “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods” provides recommendations to reduce the estimated average U.S. sodium intake of 3,400 mg/day to 2,300 mg/day over the next ten years.  FDA expects that the goal to reduce average sodium intake will benefit the U.S. population in reducing hypertension, a major risk factor in cardiovascular disease and stroke.  However, questions have been raised about what the optimal level of sodium intake might be, and whether low sodium intake exposes most people to increased risk of death and cardiovascular events while only benefiting the small minority of the population with hypertension and a high sodium intake.    

The draft guidance acknowledges that sodium reduction is a complicated endeavor, given the many functions of sodium-containing ingredients in food.  To achieve the short-term and long-term sodium intake goals of 3,000 mg/day and 2,300 mg/day, FDA proposes to set short-term 2-year targets and long-term 10-year targets for sodium content in sixteen major categories of commercially processed, packaged, and prepared foods (see page 4 of the guidance and page 2 of the slides).  These sixteen major categories include:  1) Dairy-Cheese, 2) Fats, Oils, and Dressings, 3) Fruits, Vegetables, and Legumes, 4) Nuts and Seeds, 5) Soups, 6) Sauces, Gravies, Dips, Condiments, and Seasonings, 7) Cereals, 8) Bakery Products, 9) Meat and Poultry, 10) Fish and Other Seafood, 11) Snacks, 12) Sandwiches, 13) Mixed Ingredient Dishes, 14) Salads, 15) Other Combination Foods, and 16) Baby/Toddler Foods.  Within these sixteen categories, FDA has further provided 150 sub-categories (see Appendix 1 to the draft guidance).  In the webinar, Dr. Mayne stated that FDA created the categories to avoid a “one size fits all approach.”  Categories are weighted according to the leading selling products in each category.

In a nod to concerns that sodium reduction could lead to increased levels of other nutrients, the overview section of the draft guidance states that “[c]hange should not negatively affect the nutritional quality of the foods by modifying other nutrient levels (e.g., added sugars or saturated fat) to less-healthy levels (e.g., taking into account all Dietary Guidelines recommendations and FDA policies).”  FDA intends to monitor these levels as part of an ongoing effort to monitor sodium intake levels.

While FDA acknowledged that consumer education is important, the agency has concluded that education is not enough to reduce sodium consumption.  FDA is operating under the premise that “[a]pproximately 75 percent of total sodium intake comes from processed and commercially prepared (e.g., restaurant) foods,” so FDA is relying on industry to take voluntary action with respect to reduced sodium levels in those foods.  The guidance specifically encourages large food manufacturers (whose products make up a significant proportion of national sales in one or more categories) and national and regional restaurant chains to pay particular attention to the recommendations.

FDA also acknowledges ongoing efforts to reduce sodium in foods by the New York City Department of Health and Mental Hygiene in partnership with 70 local and state health departments, initiatives by the United Kingdom’s Food Safety Authority, and the joint FDA and FSIS request for comment on sodium reduction in 2011 (see our blog post here).

As announced in the draft guidance, the Federal Register notice, and webinar slides, FDA is seeking comment on:

  • FDA’s proposed food categories
  • Methods for determining sodium content and developing recommended targets
  • Challenges of implementation for short-term and long-term goals
FDA is providing separate comment periods for the short-term and long-term sodium content targets.  With respect to the short-term 2-year targets, FDA is providing a 90-day comment period, with comments due on August 31, 2016.  For the long-term 10-year target, FDA is providing a 150-day comment period with comments due on October 31, 2016.  FDA intends to hold a series of discussions with stakeholders, with the first discussion to be held as a webinar at the end of June.

In its letter denying CSPI’s citizen petition, FDA described its approach to sodium reduction as “the most effective and appropriate approach at this time based on the scientific and technical information currently available to us about the feasibility sodium reducction across the entire breadth of the complex and heterogeneous U.S. food supply.”  FDA explicitly declined CSPI’s request to revoke the GRAS status of salt, and thereby subject salt to regulation as a food additive.  As we noted in a prior posting, CSPI sued FDA to compel action on its citizen petition.  The denial of the petition and the rollout of FDA’s sodium reduction initiative effectively bring that litigation to a close.  Two days after the rollout, CSPI filed a notice of dismissal.

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