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FDA

FDA Issues Final Rule on GRAS

By Food Safety Tech Staff
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FDA

Today FDA issued the final rule, “Substances Generally Recognized as Safe” (GRAS). The rule outlines what kind of scientific evidence can be used to demonstrate safety, along with the role of publications in assessing whether scientific evidence of safety is “generally available and accepted”, according to an FDA release. “The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.”

GRAS substances are not subject to FDA premarket approval but must meet the same safety standards as approved food additives. The agency “strongly encourages” companies to tell FDA of GRAS conclusions through the notification procedure found in the final rule, because the procedure provides the agency with important food safety monitoring information. The document will be published on the Federal Register on Wednesday, August 17.

Jim Lassiter, president and COO of Ingredient Identity

Will FSMA Push Ingredients into a New Era of Scrutiny?

By Maria Fontanazza
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Jim Lassiter, president and COO of Ingredient Identity

In June FDA officially deemed the use of partially hydrogenated oils (PHOs) as unsafe, or technically, not generally recognized as safe (GRAS). The use of PHOs has been debated for more than a decade, and as a result of FDA’s latest ruling on PHOs, food processors must remove these ingredients from their products within three years.

From preservatives to artificial sweeteners to natural flavors, the list of ingredients that go into processed foods can be quite extensive. Consumers are becoming more vigilant about what they put into their bodies, and FSMA will give FDA the authority to act immediately in instances related to safety. Does this mean that some ingredients could be in danger? The answer is yes, according to Jim Lassiter, president and COO of Ingredient Identity.  “[Ingredients] are products that you literally take inside your body, and there is nothing more personal than that,” says Lassiter. Combine this simple yet fundamental fact with consumer awareness and the entrance of FSMA, and food and beverage manufacturers may be entering a new era of scrutiny.

Food Safety Tech: From an ingredients perspective, what challenges are the industry facing?

Jim Lassiter: Implementation of FSMA. Although it’s being implemented at a slower pace than Congress desired, and I believe slower than [FDA’s] original intent, that pace is accelerating. And while the increase in challenges related to the composition and manufacturing of products will be significant, FSMA will be an overall benefit to consumer confidence.

Consumer confidence. Whether the issue is bioengineered foods or disclosure of bioengineered foods through the business of trans fats, or just the general composition and healthful nature of foods. Slowly but surely, increasing consumer awareness of food choices and diet will have a significant impact. Regardless of the type of product, this is going to be universal and will increasingly play a role in decisions that food companies make during product development.

The unknowns. We don’t know what is coming around the corner, whether it’s positive or negative. A lot of effort is being extended within the food sector to discover the next big thing—whether it’s probiotics or prebiotics; addressing product reformulation in light of the elimination of trans fat [requirement]; or something that strikes out of the blue. That is always the most challenging aspect of the ingredients industry. Foods themselves, regardless of what country you are in, are cultural in nature; they are the most personal consumer good that you can obtain. As a result, our awareness as an industry of what we do to products must bear both of those pieces in mind. We have to recognize the cultural nature of food and simultaneously recognize the personal nature of products. As a result, we won’t necessarily have insights into the great unknown or the next big thing, but at least we will have the perspective necessary to deal with any unknowns as we move forward.

FST: In the coming year, what overall effect will FSMA have on food and beverage manufacturers related to ingredients themselves?

Lassiter: From an ingredients perspective, what’s going to happen is simple and straightforward. FSMA grants FDA the broad authority to assist and act in instances where there are issues with safety. That is, however, still nebulously defined and interpreted. So, there’s potential for FDA to suddenly make a determination that an ingredient is not safe or [that it] poses some degree of safety risk. FSMA authorizes FDA to take immediate action rather than [submit] a new process notification, etc. They will also have the authority to take immediate action in the case of violations of good manufacturing practices if the perception can be tied to any aspect of safety. FSMA stands for safety; that is the hinge point on which all of this occurs.

For example, with the revised good manufacturing practice for the manufacturing of food products coming out and the full implementation of HACCP across all food categories, it’s conceivable that FDA will take immediate action on inspection deficiencies in the food manufacturing realm. I think that’s one of the big issues. I don’t want to make it sound like the boogey man is out there, but it is a very real possibility. Ingredients themselves can suddenly be identified as unsafe. I don’t see that necessarily being a very radical reaction. The potential impact is more likely to be broad, but I suspect that at some point in time, there will be an ingredient that pops up out of a FSMA ruling that will suddenly be declared to be unsafe and [consequently] removed from market.

Second, I think the implementation of HACCP across all food categories will have notable impact, initially through common regulatory action (i.e., via inspection deficiencies reports, which are very common in terms of dietary supplement manufacturer inspections). I think you’ll see those becoming increasingly common in food manufacturing operations, because of the implementation of HACCP more broadly. The first round will be more likely for increased regulatory activity in food manufacturing inspections. If that message is not received and implemented rapidly, then the extension of FSMA is that [FDA] can shut down the plant without any due process whatsoever. That looms as part of the implementation. In terms of ingredients, you’re likely to see [some] that folks may not have previously thought about [as unsafe] identified as potentially hazardous. I’m not sure in what area it will occur, but I’m fairly confident that it will happen at some point in time.  

Part II of Food Safety Tech’s conversation with Jim Lassiter takes a closer look at GRAS self declarations and the areas of confusion among companies.

Does your product contain PHOs? FDA says they're not GRAS.

Partially Hydrogenated Oils Not GRAS, Says FDA

By Maria Fontanazza
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Does your product contain PHOs? FDA says they're not GRAS.

FDA has made it official. The main source of artificial trans fat in processed foods, partially hydrogenated oils (PHOs), are not generally recognized as safe (GRAS) for use in human food. The agency is giving food manufacturers three years to comply. Companies can either reformulate products without PHOs and/or petition FDA to allow specific uses.

Does your product contain PHOs? FDA says they're not GRAS.
Does your product contain PHOs? FDA says they’re not GRAS.

FDA is defining PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than four”.

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in an FDA press release. Manufacturers have been required to indicate the presence of trans fats on product labeling since 2006. The agency estimates that between 2003 and 2012, consumption of trans fat decreased by nearly 78%, and attributes this drop to labeling requirements and consumer awareness. For the past decade, the Institute of Medicine has recommended limiting trans fat consumption.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” stated Stephen Ostroff, M.D, acting commissioner of FDA. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

After issuing its notice in November 2013 that PHOs were not GRAS, FDA received more than 6000 comments in response to this tentative determination. According to the Federal Register notice, the majority of comments from industry, trade associations, advocacy groups, health professionals, and government stakeholders were in favor of FDA’s tentative determination. Those who expressed dissent cited the agency’s scientific analysis as well as its potential effect on trade, taxes, and the potential that it could lead to bans on other substances; some provided alternatives to dealing with the issue of trans fat in food.

Standards for Animal Food Ingredients

The U.S. Food and Drug Administration has announced a strategy to establish ingredient definitions and standards for animal food in order to increase transparency and affirm the safety of the animal food supply, as required by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

As part of the strategy, FDA will review the list of animal food ingredient definitions used by industry and state regulators, which is contained in Association of American Feed Control Officials’ (AAFCO) Official Publication. AAFCO is a voluntary membership organization that includes regulatory officials of U.S. state and federal government agencies. AAFCO provides a forum for these regulatory officials to provide guidance and recommendations to ensure that the regulation of animal feeds is as uniform as possible from state to state.

The Official Publication includes FDA-approved food additives and ingredients that are generally recognized as safe (GRAS), as well as AAFCO-established definitions for other ingredients. The FDA intends to align AAFCO ingredient listings with the agency’s regulatory process and requirements.

The agency has identified the following steps for animal food ingredients:

  • FDA intends to publish a proposed rule establishing as the agency’s standards and definitions for animal food ingredients the AAFCO definitions for those ingredients that are recognized as GRAS or approved by the agency as food additives. This proposed rule will be open for public comment, and the agency will consider those comments before issuing a final rule.
  • FDA scientists will evaluate the remaining animal food ingredients listed in the AAFCO Official Publication that are currently not FDA-approved food additives or regcognized as GRAS.
    • In cases where the scientific literature supports a GRAS determination, the FDA will publish the supporting information in the Federal Register for public comment before affirming the ingredient as GRAS.
    • In cases where the data and information support a finding that the ingredient meets the food additive approval standard, the FDA intends to approve the ingredient as a food additive.
    • In cases where the FDA does not currently have data to make a GRAS determination or to approve the ingredient as a food additive, the agency will require manufacturers of these ingredients to submit a food additive petition in order to allow continued legal use of the product in animal food.

Although animal food ingredient definitions and standards generally do not vary widely across the industry, and consumers can be confident in their accuracy, FDA’s strategy will formalize definitions and standards to meet federal laws and regulations.

The agency intends to work closely with industry during this transition to minimize disruption to animal food production and ensure transparency and clarity for both manufacturers and the public.