What’s the beef with bromoform: is cow burp suppressant a food or a drug?
Adding red seaweed Asparagopsis taxiformis to cows’ diets is known to cut their methane emissions. It’s a rich, natural source of the active compound bromoform, which counteracts the formation of methane in the rumen. Efforts are underway to commercialize production of supplements and feed containing bromoform. However, there’s some uncertainty around the regulatory pathway that these products should take in the US.
Senior regulatory consultant Pete Stevenson, who specializes in animal feed compliance, sheds light on the situation.
What’s going on with bromoform?
Many studies show that feeding red seaweed to ruminants significantly reduces the amount of methane they emit through eructation, or burping. This is of great interest to beef and dairy producers since cows are regularly named as a key greenhouse gas emissions culprit. According to the US Environmental Protection Agency (EPA), a single cow produces between 154 to 264 pounds of methane per year.
Given the US National Climate Task Force’s goal to reduce greenhouse gas emissions, supplementing cows’ diets with red seaweed appears to be an easy win. Cows routinely consume a mixed plant-based diet, so adding red seaweed to the mix is not controversial from a dietary perspective. Additionally, dried red seaweed meets Association of American Feed Control Officials (AAFCO) requirements, providing the level of certain elements is included in product labelling. However, the situation becomes more complex when bromoform is extracted from seaweed for use as an additive in feed products or if the seaweed is marketed for a non-nutritive claim by a producer. Several companies have approached us for guidance on whether a regulatory pathway for food is permissible for these products, or if a pharmaceutical pathway should be taken.
So, is bromoform a food or is it a drug?
No one is disputing the fact that red seaweed is a food. It’s been consumed historically by both humans and animals, and it contains minerals, vitamins, and amino acids as well as the bromoform compound. Adding a handful of seaweed to a cow’s feed is not a contentious issue.
When it comes to producing feeds with red seaweed for the purpose of reducing methane emissions, or extracting the bromoform from red seaweed for use as an additive, the answer is less clear cut. It partly depends on how the extract is marketed and what claims are made about it.
Claiming that a bromoform product reduces methane emissions by a certain percentage or a logarithmic scale makes for an attractive investor proposition. Such products are likely to have high commercial value in the current market. Yet at present, in the US, the only regulatory route for products making such a claim is the pharmaceutical pathway.
The Food and Drug Administration (FDA) has published specific guidance on the regulation of animal feed which may also be regulated as a drug (available here). Under Section 201(g) of the Food Drug and Cosmetic Act Article 321 (which lays out the definition for a drug), bromoform products claiming to reduce methane emissions in cattle are classified as a drug not a food because they are intended to have an effect other than a nutritive or structure/function effect. This means such products are subject to the lengthier, more onerous, and costly pharmaceutical regulatory pathway. They also face more rigorous production requirements in line with FDA’s Current Good Manufacturing Practice (cGMP) Regulations for Medicated Feeds. This brings additional responsibilities surrounding safety and demonstration of efficacy which increases the costs and complexity of production.
Is the situation likely to change?
There’s an ongoing debate on this matter in the US. One school of thought suggests that because bromoform occurs naturally in red seaweed and reduction of methane isn’t treating a disease state or intended for performance benefit in the animal, there may be a pathway for a food classification. FDA is currently evaluating this stance and may use its rulemaking authority to allow for such a product to go into the market. Groups including the American Feed Industry Association (AFIA) and many individual companies have been working with FDA to achieve a right-sized approach.
FDA would likely be somewhat restrictive in the types of claims allowed, but any movement would be a win for manufacturers and growers. However, this is likely to take time as FDA will need to consider evidence surrounding the environmental and physiological effects of increased levels of bromoform, any potential passthrough effects, and the rates of safe consumption for both animals and humans. Because of the nature of this issue, it’s also likely that agencies such as EPA will be consulted, further extending the timelines.
What should bromoform manufacturers do?
It is possible, and may be advisable, for manufacturers and other stakeholders to join the bromoform debate. When manufacturers are more educated on the regulatory environment, and can provide sound science for their products, everyone benefits. Consulting groups and trade associations can also play a vital role as they represent multiple companies and concerns, bringing more gravitas to regulator discussions.
A provisional registration has been granted by the California Department of Food and Agriculture for one seaweed-based additive already. The claim being made for the product is a soft claim suggesting that cows are able to retain more energy because of the additive. The approval was granted under the Generally Recognized as Safe (GRAS) designation for substances added to human food or animal feed. This could set the precedence for commercialization of bromoform-based products for cattle which do not make overt claims related to methane mitigation.
One thing is clear: inhibiting cows’ methane emissions could play a pivotal role in environmentally sustainable beef and dairy production. Manufacturers that navigate the regulatory landscape effectively and proactively have an opportunity to claim a position at the forefront of this emerging market.
Find out more about our services surrounding US animal feed regulations here.