The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford.[2] A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York.[3] In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.[4] The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form.[5] It replaced the earlier Pure Food and Drug Act of 1906.
Contents
[
edit
]
The FDC Act has ten chapters:[6]
Food coloring
[
edit
]
The FD&C Act is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6". The Act made the certification of some food color additives mandatory. The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, and numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs for external application or cosmetics.[10] Color additives derived from natural sources, such as vegetables, minerals or animals, and artificial counterparts of natural derivatives, are exempt from certification. Both artificial and naturally derived color additives are subject to rigorous standards of safety before their approval for use in foods.[11]
Certifiable colors
[
edit
]
Food additives
[
edit
]
The FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used.[citation needed]
Definition of food additive
[
edit
]
A shortened definition of "food additive" is defined by the FDA as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives."[14] The full definition can be found in Section 201(s) of the FD&C Act, which provides for any additional exclusions.[15]
Homeopathic medications
[
edit
]
Homeopathic preparations are regulated and protected under Sections 201(g) and 201(j), provided that such medications are formulated from substances listed in the Homeopathic Pharmacopoeia of the United States, which the Act recognizes as an official drug compendium.[16]
However, under separate authority of FTC Act, the Federal Trade Commission declared in November 2016 that homeopathic products cannot include claims of effectiveness without "competent and reliable scientific evidence". If no such evidence exists, they must state this fact clearly on their labeling.[17]
Bottled water
[
edit
]
Bottled water is regulated by the FDA as a food. The Agency has published identity standards for types of water (mineral water, spring water), and regulations covering water processing and bottling, water quality and product labeling.[18][19][20]
Cosmetics
[
edit
]
This Act defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance." Under the Act, the FDA does not approve cosmetic products, but the Act prohibits the marketing of adulterated or misbranded cosmetics.[21] However, the FDA does not have the authority to order recalls of cosmetics.[22][23] If a company is selling a product that is adulterated or misbranded, the FDA can ask the company to recall their product or sue them.[21] The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated.[21]
Medical devices
[
edit
]
On May 28, 1976, the FD&C Act was amended to include regulation for medical devices.[24] The amendment required that all medical devices be classified into one of three classes:
For devices that were marketed prior to the amendment (preamendment devices) and were classified as Class III, the amendment obligated the FDA to review the device to either reclassify it as a Class II device subject to premarket notification, or to require the device manufacturer to undergo the premarket authorization process and prove the safety and efficacy of the device in order to continue marketing it. Notable examples of such preamendment devices are those used for electroconvulsive therapy, which the FDA started reviewing in 2011.[25][26]
Premarket notification (510(k), PMN)
[
edit
]
Section 510(k)[27] of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device.
This is known as premarket notification, PMN, or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.[citation needed]
Any device that reaches market via a 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976 (a "predicate device"). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA.
A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.
A 2011 study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously cleared by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues.[28] This may lead to a reevaluation of FDA procedures and better oversight.[citation needed]
Premarket approval (PMA)
[
edit
]
Premarket approval (PMA) is the most stringent type of device marketing application required by FDA. Unlike the 510(k) pathway, the maker of the medical device must submit an application to the FDA and must receive approval prior to marketing the device.[29]
The PMA application contains information about how the medical device was designed and how it is manufactured, as well as preclinical and clinical studies of the device, demonstrating that it is safe and effective for its intended use.[30] Because the PMA requires a clinical trial it is significantly more expensive than a 510(k).[31]: 7
Automatic Class III designation (de novo classification)
[
edit
]
The Food and Drug Administration Modernization Act of 1997 created section 513(f)(2) of the FD&C Act, which obligated the FDA to establish a risk-based regulatory system for medical devices. As a result, the FDA established a de novo pathway for devices that would automatically be classified as Class III because there was no already-existing device that could be used a predicate for a 510k submission, but for which general controls or general and special controls could provide a reasonable assurance of safety and effectiveness.[32][33]
Related legislation
[
edit
]
The Wheeler-Lea Act, passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs.
[
edit
]
Descriptions of these can be found at the FDA's web site.[34]
Amendments:
Other laws:[42]
Comparison to state laws
[
edit
]
Some US states have adopted the FD&C Act as an equivalent state law and will by default adopt any changes to the Federal law as changes to the state law as well.[citation needed]
See also
[
edit
]
References
[
edit
]
You may have just started experimenting with homemade cosmetics recipes or have experience making products for friends and family. If you want to take your hobby to the next level, you’ve probably wondered, “Can I make and sell my own beauty products?” No matter where you are in your DIY beauty journey, the answer is yes.
The UK beauty industry is huge. According to comparison platform Finder, it was worth £27 billion as of 2020, ranking as the seventh-largest cosmetics market globally. This means there’s plenty of competition out there for new brands and products, but also lots of opportunities to tap into the market with something new.
Anyone can make and sell beauty products, whether they’re doing it by hand from their kitchen or manufacturing on a larger scale. If you’re thinking about officially launching your line of homemade moisturisers or wondering whether it’s time to share your natural skincare brand with the world, you’ve come to the right place. Read on for our expert tips to help you get started.
When selling any product, the first step is to figure out who your market is. This is especially important in the beauty industry, where so many different cosmetic products vie for the customers’ attention. Start by thinking about your product’s niche, work out what makes it different from what’s already out there and think carefully about the group of customers most likely to buy into what you’re selling. Targeting a specific group of customers is vital at the beginning of your journey, as it will be easier to make key decisions. You can always expand your business later to target new market segments.
When thinking about your product and target market in these early stages, it may help to ask yourself these questions:
If you’ve not already got a finished product, now’s when you’ll need to get to know different ingredients and experiment with formulas. Consider how each of your ingredients interacts with one another and the properties or benefits that they bring to your product.
If you’re starting out, a natural skincare course will arm you with the knowledge needed to make a key range of products and give you an understanding of some of the raw materials used within the beauty industry.
You may want to make a facial moisturiser, an exciting new bath bomb, a luxurious body lotion or a new range of mineral makeup. There's no reason you can’t make your product work – you just need to think about making it unique and perfect the formula.
Often, when asking that initial question, “Can I make and sell my own beauty products?” fledgling beauty biz owners have a super ambitious goal in mind. While it’s good to aim high, you also need to be realistic as you attempt to break into this incredibly competitive market.
Starting with a small capsule collection of products is sensible as it will be much easier to get it right from the beginning, limiting the amount of formulating, testing, manufacturing and marketing you’ll need to do. Give yourself the best chance of success by reigning yourself in a little, keeping your other great ideas for future product launches.
Once you’ve finished tweaking your formulas, ensure that they’ve been properly tested before you move onto the next stage. Your final products must be safe and stable, plus they’ll need to abide by the cosmetic regulations in the country where you plan to sell.
Each region will have its own laws around how cosmetics must be manufactured, tested, labelled and marketed, so you’ll need to do a lot of research into these regulations to ensure your products and practices are legal and safe.
If you plan to sell beauty products in England, Wales and Scotland, they must comply with the UK Regulation for cosmetics (Schedule 34 of the Product Safety and Metrology Statutory Instrument). If you’re selling products in Northern Ireland, they must comply with Regulation EC 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
The Cosmetic, Toiletry and Perfumery Association (CTPA) is a valuable source of information. Use their help tool to access a variety of useful resources.
Your formulas are in the final stages, so what’s next? Now, you need to build your brand. Consider the feeling you want customers to have when engaging with you and your products. Use this to make decisions about voice, branding, packaging and your website if you’ll be using one.
You must figure out how to communicate your brand values and create a unique customer experience, as this will play a massive part in the marketing of your products. The brand you create should be showcased online, on social media, on the packaging and in any advertising to build brand awareness and tell a story.
In the beauty industry, packaging serves multiple purposes. Not only is it used to represent your brand, market your product and list any ingredients, but it’s also a vessel for your formula. This means you’ll need to choose the correct container to keep it safe, stable and easy to dispense.
You’ll need to find a trusted packaging supplier and source hygienic containers that fit their purpose. Depending on your product, your packaging may need to protect it during shipping, double as an applicator or keep it safe from contamination. Be sure to test your packaging as well as the formula itself, ensuring that it does its job well before you get to the marketing stage.
Your beauty business is just as valid whether you sell at local markets, on social media, through a website or in a brick-and-mortar store. Decide how you’d like to start and make the necessary arrangements to get set up. You may decide to start small and sell locally before moving onto other platforms as your business grows.
If your brand’s differentiator is that it’s affordable or luxury, you’ll have already put a lot of thought into the price you’ll be charging. If you’re still unsure at this point, you’ll need to get clear on pricing now.
Think about your production costs, how many sales you’d need to generate to cover these, and where you want your products to sit on the affordability scale compared to competitors. Additional market research may be helpful at this stage.
Emerging beauty brands must face the challenge of competing for attention in a saturated market, so you should start by thinking back to your target market and find out where the best places are to reach them. Has previous market research provided you with any data that might be helpful?
The cosmetics industry was an early adopter of social media marketing, with 2016 research from Statista showing that 96% of beauty brands already had an Instagram profile at this time. The industry has continued to adapt its strategy in this space, partnering with other brands, blogs and beauty influencers for greater exposure.
Social media is an excellent place to start for any new brand, but you should also experiment with other marketing campaigns to find out what works for you.
Shipping beauty products comes with its own set of challenges, especially with delicate products such as makeup or fragile packaging such as glass or plastics. It’s advisable to run multiple test orders before fulfilling your first sale, ensuring that your customers have a positive experience from the outset.
As well as the design and practicality of your packaging, you’ll also need to consider your returns policy, ensuring that it’s a seamless process for everyone involved. Finally, you’ll need to set up strong customer service processes to keep purchasers updated, track orders and make it easy for customers to contact a representative.
You’re finally ready to launch your new products – congratulations! Take a leap of faith and start making those sales.
Remember, there are many things to learn when starting a new business, so everything doesn’t have to be perfect right away. As you learn more about the process and get a greater insight into your customers, you’ll grow and improve as a small biz, making key changes along the way.