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FDA Releases Warning Letters to CBD and Hemp Oil Companies

Last week the Food & Drug Administration (FDA) made public three new warning letters to Cannabidiol (CBD) and hemp oil product companies sent by FDA and the Federal Trade Commission (FTC). FDA has previously targeted cannabis product companies.

The new warning letters are consistent with FDA Commissioner Scott Gottlieb’s recent statements that the FDA will go after manufacturers of CBD products that make health and wellness claims that FDA views as egregious. For example, the CBD companies in question allegedly marketed their products for Alzheimer’s disease, fibromyalgia, inflammation, skin conditions, autoimmune disorders, anxiety, cancer pain, PTSD and depression, to name a few symptoms. These companies are making food, dietary supplements, and cosmetic products, as well as products for pets (CBD for dogs). (more…)

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Bioengineered Food Disclosures

Earlier this year, the U.S. Department of Agriculture (USDA) proposed a new regulation that would require food manufacturers to disclose information about bioengineered (BE) food and BE food ingredients. The proposed rule is the result of a 2016 law that required the USDA to establish a National Bioengineered Food Disclosure Standard for all food. For purposes of the BE disclosure law, “food” includes alcohol beverages intended for human consumption as well as non-alcohol beverages.

Read the full article.

Originally published in The New Brewer, November/December 2018.

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FDA to Hold Public Workshops Addressing Menu Labeling Final Rule

The US Food and Drug Administration (FDA) has announced a series of public workshops about menu labeling to help the industry comply with requirements to provide calorie and other nutrition information to consumers. The workshops will address the menu labeling final rule, which require certain chain restaurants and similar retail food establishments to give consumers nutrition information on standard menu items. The compliance date for these requirements is May 5, 2017.

These workshops are to continue FDA’s dialogue with the industry about implementation of the menu labeling final rule and provide additional clarity on the requirements. Interested parties will have the opportunity to discuss specific menu labeling questions and concerns directly with FDA subject matter experts through pre-scheduled one-on-one sessions. (more…)

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Raw Materials Compliance

Imagine that you’re waiting for an international hop order to clear customs and you receive a panicked call from your broker. She tells you that the U.S. Food and Drug Administration (FDA) tested the hops for pesticide residues and found some that are not approved for use on hops in the United States. The government will not allow the hops to be imported. What are you to do?

Read the full article, originally published in the November/December 2015 issue of The New Brewer.

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FDA “Action Level” for Arsenic in Apple Juice

On Friday, July 12, the U.S. Food and Drug Administration (FDA) proposed a new “action level” for arsenic in apple juice.  The FDA’s Federal Register notice and other supporting documents that accompanied the announcement are linked below.

An action level generally establishes the threshold at which FDA will consider a food or food ingredient “adulterated” within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act).  For apple juice, FDA proposes a 10 parts per billion (PPB) level.  This level is considerably lower than the 23 PPB “level of concern” previously established by FDA.

The FD&C Act’s ingredient safety standards apply to all “food” – a term defined broadly in the Act to encompass all alcohol beverages.  Thus, the 10 PPB standard will be applied to apple juice used to manufacture hard cider.  As such, cider producers should review the implications of the proposed standard on their own operations and give thought to implementing procedures to comply with the 10 PPB standard in the future.

Click here to read the FDA’s notice in the Federal Register.

Click here to read the draft Guidance for Industry Arsenic in Apple Juice: Action Level.

Click here to read the draft Supporting Document for Action Level for Arsenic in Apple Juice.

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