FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for December 2017

Posted on Friday, December 22 2017 at 9:08 pm by -

FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products

By Carolina M. Wirth

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry stakeholders regarding its current regulatory framework for homeopathic drug products, the agency has issued a draft guidance proposing a new, risk-based enforcement approach for drug products labeled as homeopathic.  Following the public hearing, FDA received more than 9,000 comments in response to its request for “broad public feedback on its enforcement policies related to drug products labeled as homeopathic.”[1]

According to FDA, after considering the information obtained from the public hearing, as well as the comments submitted to the public docket, it determined that

it is in the best interest of the public health to issue a new draft guidance that proposes a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval.[2]

While the draft guidance provides a risk-based enforcement framework for products labeled as homeopathic, it leaves open the question as to how the agency will address the marketing of homeopathic drug products in the future considering that the draft guidance, when finalized, will withdraw FDA Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed,[3] which was issued by the agency in 1988.
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Posted on Monday, December 4 2017 at 5:39 pm by -

Menu Labeling Update: Plans On-Track for Implementation in May 2018

By: Alyson L. Wooten, Pharm.D.

On November 7, 2017, the U.S. Food and Drug Administration (FDA or the Agency) released the much-anticipated draft supplemental guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). The Draft Guidance provides further details on the Menu Labeling Final Rule (Menu Labeling Rule) and responds to comments the Agency received on the interim final rule, which was released in May 2017.

The Agency’s Menu Labeling Rule has had a long history. The rule requires restaurants and “similar retail food establishments”, such as grocery stores and convenience stores that are part of a chain of 20 or more locations, doing business under the same name, and offering similar food menu items from a menu or menu board to provide: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement with written nutrition information (which must be provided if requested).

After release of the interim rule in May 2017, which was originally presented in 2015, a number of restaurants and stores in New York City filed suit seeking to prevent New York City from enforcing its substantially similar rule against nutritional information (read here). The City agreed to delay enforcing the rule until March 7, 2018, and the parties reached a settlement agreement contingent upon implementation of the rule by this date. Following the settlement, Scott Gottleib, FDA Commissioner, announced that the Agency planned to release a practical guide on the rule before the end of 2017. The November 7 Draft Guidance seeks to fulfill this promise of a “practical guide”, and appears to continue to suggest that the Menu Labeling Rule will be implemented in May 2018.

While many support the overall goal of the Menu Labeling Rule, many organizations such as the National Restaurant Association are concerned about the patchwork of state and local menu requirements, and the burden created by different store formats attempting to comply with varied rules and regulations. The newly issued Draft Guidance attempts to address these issues has been met with mixed reactions.

As an example of the concerns over this rule, a big issue for many pizza chains is the burden of addressing the thousands of topping combinations people may want on their pizza in calorie counts posted on menu boards in the store. Many pizza chains have been pushing for FDA to allow calorie information to be posted on their website instead of in the store location, with the rationale that the majority of customers order their pizza online rather than in-store. The Agency has rejected this approach in the Draft Guidance, noting that calorie count information may appear online but, if they have in-store menu boards, the calorie information must also appear on the board.

The Agency has indicated that it is willing to continue considering feedback and questions concerning the Draft Guidance. Comments on the proposal are due January 8, 2018.