U.S. Food and Drug Administration

Soy milk. Almond milk. Coconut milk. With the increase in health-conscious shopping and non-dairy diets, these terms and others have become household names.

But the Food & Drug Administration (“FDA”) recently suggested these products don’t constitute milk at all, since they do not come from animals. According to multiple sources, during the Politico Pro Summit in July, the FDA Commissioner commented that the FDA is probably not currently enforcing its “standard of identify” for milk considering the FDA defines “milk” by referencing the milking of cows.

Manufacturers and sellers of non-dairy products currently advertised and labeled as “milk” should keep watch on whether the FDA issues guidance on this issue or decides to strictly enforce its current definition of “milk.” If it does, the marketing for these products may drastically change.

Although they may not immediately connote a traditional form of advertising, food menus and labels serve as a form of advertising in the minds of many consumers and are regulated by Food & Drug Administration (“FDA”).  Read below for two important updates/reminders in the food-related space.

62909081 - calorie dessert for each piece. problem with obesity. popular dessert menu.Menu Labeling:  As a follow up on a prior blog post and as detailed in today’s Consumer Update from the FDA, the FDA is requiring this month that certain types of food establishments post calorie information on menus and menu boards and provide nutrition information upon request in order to help consumers make informed choices in ordering food items.  The FDA’s requirement applies to chain restaurants as well as eating establishments with more than 20 locations, and the FDA’s Consumer Update provides examples of the types of locations where consumers should expect to now see calorie posting, if they don’t already.

Nutrition Facts Label:  Following up on another prior blog post, the FDA recently announced that it is extending the deadline to comply with its Nutrition Facts Label rule and its Serving Size rule by 18 months.  Instead of requiring compliance by certain manufacturers this summer, the FDA will now require compliance by January 1, 2020 for larger food manufacturers and January 1, 2021 for smaller food manufacturers.  This extension is intended to provide sufficient time to ensure industry compliance.

Fast food (hamburger fries and drink) illustrationFollowing upon on my earlier blog post about the Food & Drug Administration’s (“FDA”) menu labeling rule, which implements the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010, the FDA recently released new supplemental guidance in advance of the current compliance deadline in May 2018.  This new guidance is meant to address concerns regarding implementation of the menu labeling rule and is open for public comment until early January 2018.  The FDA cautions that its guidance is not binding and is merely meant to represent the FDA’s current thinking on the issue.  For a more detailed discussion of the menu labeling rule and its impact, take a look at my colleague Alexander S. Radus’ recent post on the firm’s Franchise Law Update blog.

 

Pet products are subject to advertising, labeling, and safety-related laws and regulations just like any human product.  For an update on the Food & Drug Administration’s guidance on the compounding of animal drugs from bulk drug substances and the labeling of pet medications, see Nancy Halpern’s recent blog post on Fox Rothschild’s Animal Law blog.  For more information on the FDA’s regulation of pet and veterinary products, see the FDA’s website.

Last month, the Food & Drug Administration (“FDA”) sent a lengthy warning letter to Nashoba Brook Bakery, a bakery based in Massachusetts, identifying a number of alleged violations of food regulations and labeling regulations.  One such allegation was that the bakery’s Nashoba Granola product improperly listed “love” as an ingredient on its label.  Specifically, the FDA alleged, “Your Nashoba Granola label lists ingredient ‘Love’.  Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1).  ‘Love’ is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.”

The FDA’s love-related allegation has garnered some press both locally and nationally and is a good reminder regarding labeling regulations and the FDA’s enforcement authority.  Other FDA warning letters can be found here.

 

 

The U.S. Food and Drug Administration (“FDA”) regulates dietary supplements as food, not as drugs.  In general, dietary supplements are taken orally and contain a dietary ingredient such as a vitamin, mineral, amino acid, herb, botanical, or other substance used to supplement the diet.  The FDA warns consumers that dietary supplements may be harmful, may contain hidden or deceptively-labeled ingredients, and are not intended to treat, diagnose, cure, or alleviate the effects of any disease.  In fact, the FDA has recalled numerous products containing potentially harmful ingredients.

Although federal law requires that dietary supplements be labeled as such (either as a “dietary supplement” or with “[ingredient description] supplement”) and that products be labeled correctly and advertised fairly, the FDA does not pre-approve dietary supplements or require that they be proven safe before they are marketed and sold.  Nor does the Federal Trade Commission (“FTC”) pre-approve any advertising related to dietary supplements.  As a result, there is no requirement that manufacturers/sellers prove that their products are safe or that all advertising claims are accurate before they market or sell the products.  Instead, it is the company’s responsibility to ensure product safety and truthful advertising, and the FDA and FTC only get involved after such products have already entered the market—with the FDA regulating safety issues and the FTC regulating advertising issues.

To bolster its ability to regulate such safety issues, the FDA requires that sellers of dietary supplements report any serious adverse events reported by consumers or health care professionals within 15 days of receipt and that the FDA monitor and investigate those reports.  Likewise, the FDA monitors and investigates any adverse event voluntarily reported by consumers or health care professionals and encourages such voluntary reports to be made directly to the FDA as soon as possible.

As always, manufacturers/sellers of dietary supplements should make sure that their products are safe, properly labeled, and advertised truthfully.  In addition, companies should make sure to report any serious adverse events to the FDA within the required time frame.

Fast food (hamburger fries and drink) illustrationAdvertising comes in many forms. Although menu labeling requirements may not seem like a traditional form of advertising, menus are consumer-facing and undoubtedly contain information that affect consumer purchasing decisions. Thus, it’s important for affected companies and their advertising departments to be aware of menu labeling rules and requirements and to ensure timely compliance.

For a recent discussion on the Food & Drug Administration’s menu labeling rule, which implements the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010, and its extension of the date for restaurants and similar retail food establishments to comply, take a look at my colleague Alexander S. Radus’ recent post on the firm’s Franchise Law Update blog.

Also, for a related discussion on the FDA’s changes to the Nutrition Facts label required for packaged foods, see my earlier post on this blog.

On May 20, 2016, the Food and Drug Administration (“FDA”) announced new changes to the Nutrition Facts label required for packaged foods.  The FDA’s intent was to create a new label that would make it easier for consumer to make informed food choices and would reflect new scientific information, such as the link between a consumer’s diet and chronic diseases (e.g. obesity and heart disease).

The FDA set the original compliance deadline for the new Nutrition Facts label as July 26, 2018, with an additional year for small businesses (manufacturers with food sales of less than $10 million annually).  However, on June 13, 2017, following industry and consumer group feedback, the FDA announced that it intended to extend the original compliance deadline so that it could provide manufacturers with necessary guidance, allow manufacturers additional time to complete and print new labels for their products, and minimize the period during which consumers will see both labels in the marketplace.  The FDA has not yet indicated what the new compliance deadline will be, but industry and consumer groups will certainly be watching closely.

Detailed information regarding the new Nutrition Facts label and the FDA’s changes are available on the FDA’s website.  In addition, the FDA has developed a side-by-side comparison of the original Nutrition Facts label and the new Nutrition Facts label, making the FDA’s changes easy to spot.  For example, certain items of information–“servings per container,” “serving size,” and “calories”–will now appear in bigger and/or bolder font.  In addition, the FDA is requiring that “serving size” be updated to more realistically reflect the amount of food customarily eaten at one time, that certain changes be made for certain size packages, and that “daily values” be updated to reflect new scientific evidence.  The FDA is also requiring the addition or removal of certain items of information.  For example, in light of scientific research indicating that the type of fat is more important than the amount, the FDA has removed “calories from fat” from the label entirely.  The FDA has also removed “vitamin A” and “vitamin C” but has added “vitamin D” and “potassium” in recognition of research indicating that the lack of such nutrients is associated with increased risk of chronic disease and is requiring that manufacturers now declare the actual amount of the four required vitamins/minerals in addition to their “daily value.”  As another addition, the FDA is now requiring “added sugars” be declared directly beneath the “total sugars” listing.  The FDA has also modified the list of required nutrients that must be declared at the bottom of the Nutrition Facts label and has updated the footnote to better explain the meaning of “daily value.”

After 20 years with the current Nutrition Facts label, the FDA has determined that change is in order.  How soon that change will ultimately take effect is yet to be determined.

 

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so that the FDA can ensure each product is safe and effective for its intended use. The FDA is concerned about the marketing and selling of products that have not been approved, particularly because such products may contain dangerous ingredients or may cause harm by negatively impacting beneficial treatments. Often such products are advertised as “natural” or are labeled as a dietary supplement, which may be a tip-off to consumers that the products have not been approved by the FDA.

cancer pic
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The FDA has identified the following advertising phrases as “red flags” that may signify a fraudulent product:

  • Treats all forms of cancer
  • Miraculously kills cancer cells and tumors
  • Shrinks malignant tumors
  • Selectively kills cancer cells
  • More effective than chemotherapy
  • Attacks cancer cells, leaving healthy cells intact
  • Cures cancer

Additionally, the FDA has stated that the following catch phrases should tip-off consumers to a potentially bogus health-related product:

  • One product does it all
  • Personal testimonials
  • Quick fixes
  • “All natural”
  • “Miracle cure”
  • Conspiracy theories

In April, the FDA sent 14 warning letters to companies that it determined were making fraudulent claims on their websites related to purported cancer treatments. Fraudulent claims are those that deceptively promote a product as effective against a specific condition—in this instance, cancer—that has not been scientifically proven to be safe and effective for its claimed purposed. According to the FDA, if the companies to which it sent letters do not comply with its warnings, the FDA may take further legal action in order to ensure that such products do not reach consumers.

The FDA requests that consumers avoid use of potentially unsafe or unproven products and to discuss any cancer treatments with their healthcare providers (or, in the case of pets, with their veterinarian and veterinary oncologist). As always, companies that market or sell products requiring FDA approval should ensure that such products are fairly advertised, are properly labeled, are effective and safe for their intended use, and are indeed approved as required.

The U.S. Food and Drug Administration (“FDA”) requests that consumers report any issues they experience with FDA-regulated products so that the FDA can further protect the public health. But it isn’t always clear which products the FDA regulates and which products it doesn’t. Generally, the FDA regulates the following product categories: certain foods, drugs, biologics, medical devices, electronic products that give off radiation, cosmetics, veterinary products, and tobacco products. Within each category is a number of products subject to the FDA’s regulatory authority. A more detailed, though non-exhaustive, list of the products the FDA regulates can be found on the FDA’s website. According to the FDA, these products account for about one-fifth of annual spending by U.S. consumers.

FDA
Copyright: bakhtiarzein / 123RF Stock Photo

The FDA is committed to ensuring that the products it regulates are safe, effective, and correctly labeled. But the FDA does not pre-approve for safety and effectiveness all of the products it regulates before such products can be marketed and sold. For example, the FDA does pre-approve new drugs, biologics, and certain medical devices, but does not pre-approve cosmetics (with the exception of certain color additives) or dietary supplements (though a notification is required for those containing a new dietary ingredient). However, the FDA requires that cosmetics, dietary supplements, and other products be safe for their intended use and be properly labeled/advertised. Accordingly, for such products that the FDA does not pre-approve, the FDA still has regulatory authority to take action when a safety issue arises. With respect to tobacco products, the FDA does not regulate safety in the same way as with other products, as the FDA views tobacco use as a major threat to public health. Notably, last year, the FDA finalized a new rule extending its regulatory authority to all tobacco products, including e-cigarettes, and restricting youth access to such products.

As always, companies should ensure that they products they market and sell are safe for their intended use, are properly labeled, and are fairly advertised. One form of advertising that has caught the FDA’s attention is the phrase “FDA Approved.” The FDA’s recently-updated explanation on what it does and doesn’t approve (and under what circumstances) can be found on the FDA’s website. The FDA’s website also contains detailed information for companies that market and sell FDA-regulated products, including the ability to search for guidance documents that describe the FDA’s interpretation on various regulatory issues and the ability to submit questions regarding the FDA’s policies, regulations, and regulatory process.