ALCOHOL LAW ADVISOR
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
Food Safety and FDA
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FDA to Regulate Brewers and Distillers That Sell Waste Grain for Animal Feed

by | Oct 25, 2013 | ,

The U.S. Food and Drug Administration (FDA) will publish its Preventive Control Rule for Feed next Tuesday, October 29, 2013.  The FDA’s Fact Sheet about the proposed rule can be found here.  The comment period is 120 days and comments accordingly should be due on or around February 26, 2014.  More information is available on the following FDA webpage: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm.

Quite notably, the FDA rule proposes to cover breweries and distilleries if they sell spent grain to farmers for use in animal feed.  This aspect of the rule could regulate hundreds of breweries, distilleries and ethanol plants as animal feed producers.  The rule does propose exempting smaller companies, suggesting between $.5 and $2.5 million in feed sales as the appropriate threshold for regulation.

Among other things, application of the proposed rule to a facility would require:

  1. a written food safety plan;
  2. hazard analysis;
  3. preventive controls for hazards that are reasonably likely to occur;
  4. recall plan for animal food with a hazard that is reasonably likely to occur;
  5. monitoring;
  6. corrective actions;
  7. verification; and
  8. associated record keeping.

The proposed rule also would establish specific good manufacturing practices (GMP) for animal feed.

Any brewer or distiller currently supplying spent grain for feed should pay attention to these proposed rules.  Participation in the comment period may reduce the impact of these regulations or obtain some exemption for the industry.  If those efforts fail, companies above the regulation’s size threshold (whatever that turns out to be) must either gear up to comply with these rules or consider new ways to dispose of their spent grains.



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FDA Issues New Rules on Gluten Labeling

by , and | Aug 2, 2013 | , ,

The U.S. Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it “gluten- free,” “without gluten,” “free of gluten” and “no gluten.”  The rule applies to all FDA-regulated alcohol beverages, which include wines (and ciders) below 7 percent alcohol by volume, and malt beverages that are not made with both barley and hops; but does not apply to alcohol beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.  The notice includes a commitment by the FDA to work with TTB to harmonize labeling issues.  The two agencies consult as needed under an interagency Memorandum of Understanding, and TTB may develop new guidance based on the FDA final rule.

For brewers, FDA intends to issue a proposed rule on gluten-free labeling of hydrolyzed and fermented foods (like beer).  This rule will address compliance when analytical methods are not available because the food is fermented or hydrolyzed or contains fermented or hydrolyzed ingredients.  FDA intends to address the “gluten-free” labeling of beers subject to FDA’s labeling requirements in that proposed rule.

In light of this, FDA will exercise enforcement discretion with respect to the requirements for “gluten-free” labeling for beers subject to FDA labeling requirements.  This will extend to beers that currently make a “gluten-free” claim and that are:  (1) made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten.  This enforcement discretion pertains only to these beers subject to FDA labeling requirements that make a “gluten-free” claim as of August 5, 2013 pending completion of the rulemaking process with respect to fermented or hydrolyzed products.  To the extent that a beer manufacturer wants to make a new gluten-free claim that is not present on a label as of August 5, 2013, they should contact FDA regarding the possible expansion of FDA’s consideration for the exercise of enforcement discretion related to such labeling.

FDA expects beer manufacturers using a “gluten-free” claim to take appropriate measures to prevent cross-contact with gluten-containing grains during production, processing, storage or other handling practices.  Last, FDA notes that beer manufacturers whose beers are subject to FDA’s labeling requirements can make claims about the beer being processed to reduce gluten provided such statements are truthful and not misleading.  FDA cites as examples the statements in TTB’s interim policy on gluten content statements (“Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten.  The gluten content of this product cannot be verified, and this product may contain gluten.”)

For those interested in the application of FDA’s final rule to gluten-free claims about other FDA-regulated products, one of the criteria for using the claim “gluten-free,” is a gluten limit of less than [...]

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FDA to Propose Rules to Address Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors

by and | Jul 26, 2013 |

On Monday, July 29, 2013, U.S. Food and Drug Administration (FDA) will publish two proposed regulations to implement parts of the Food Safety Modernization Act (FSMA).  The proposed rules will address: (A) Foreign Supplier Verification Programs (FSVP); and (B) the accreditation of third-party auditors.  The comment period for these proposed rules runs 120 days, putting the comment deadline on or about November 26, 2013.

A.  FSVP:  In brief, the FSVP proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures equivalent to those domestically under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  These processes and procedures include reasonably appropriate risk-based preventive controls, hazard analysis and risk-based preventive controls, and standards for produce safety.  Moreover, controls should ensure the food is not adulterated or misbranded.

B.  Accreditation of Third-Party Auditors:  Under the accreditation rule, FDA will recognize accreditation bodies, which would in turn accredit third-party auditors to, among other things, conduct food safety audits and issue certifications for foreign facilities and food under specified programs.  Importers will not generally be required to obtain certifications, but in certain circumstances FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the United States that FDA has determined poses a food safety risk.  FDA may also use accreditation to determine whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.

These two new proposed rules are part of several FDA initiatives to implement the FSMA.  Previously, FDA published proposed rules for produce safety and preventative controls for human food.  The comment period for those two proposed rules ends on September 16, 2013.

In addition, FDA has three other regulations to propose in connection with FSMA:  (1) preventative controls for animal feed; (2) protection against intentional adulteration; and (3) sanitary transportation of food.

By Court order, all of FDA’s FSMA rules must be proposed by November, 30, 2013, the comment period must end by March 31, 2014, and FDA must publish all final regulations no later than June 30, 2015.



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FDA “Action Level” for Arsenic in Apple Juice

by | Jul 23, 2013 |

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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TTB Ruling on Voluntary Serving Fact Labeling

by | Jun 7, 2013 | , ,

On May 28, 2013, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published a new Industry Circular, Number 2013-2, that authorizes voluntary “serving facts” labeling on alcohol beverages regulated by TTB under the Federal Alcohol Administration Act (i.e., it does not apply to wine below 7 percent alcohol by volume (ABV) or beers made without malted barley or hops).

The most relevant points:

  1. Everything discussed in Industry Circular 2013-2 concerns voluntary labeling statements.  It mandates no new labeling disclosures.
  2. The serving facts statement mostly contains the same information contained in the “statement of average analysis” required for “light” and similar products.
  3. TTB gives producers and importers the option of adding a statement showing the amount of pure alcohol per serving or per container of a product (e.g., 0.6 fl. oz. of alcohol per serving), accompanied by alcohol content (ABV) information.
  4. The serving facts can be displayed in a panel (FDA style) or “linear” fashion.
  5. Producers and importers have the option of showing serving facts as a substitute for the statement of average analysis required on “light” and similar products.
  6. TTB recognizes a wider range of serving sizes for wine, malt beverages and distilled spirits, depending on the strength of the product.  For example, instead of a 12 oz. serving size for all malt beverages, serving facts statements for higher-strength beers should use smaller serving sizes for progressively higher-alcohol products.
  7. If a producer or importer follows the format authorized by TTB, it can add serving facts to existing labels without the need for a new COLA.


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